Baclofen

 

CNS depressants, baclofen [2] ---> SPC of [2] of eMC

The concomitant administration of baclofen and other medications that have a suppressing effect on functions of the central nervous system can enhance the action of baclofen

 

NSAID, baclofen

NSAIDs possibly reduce excretion of baclofen (increased risk of toxicity).

 

Ability to drive, baclofen [2] ---> SPC of [2] of eMC

The ability to drive or operate machinery may be considerably impaired during treatment with baclofen

 

Alcohol, baclofen [2] ---> SPC of [2] of eMC

The concomitant intake of alcohol and baclofen should be avoided as the interactions with alcohol are unpredictable.

 

Alizapride, baclofen

Increased CNS depressant effect

 

Analgesics, baclofen [2] ---> SPC of [2] of eMC

The concomitant administration of baclofen and other medications that have a suppressing effect on functions of the central nervous system can enhance the action of baclofen

 

Antihypertensives, baclofen [2] ---> SPC of [2] of eMC

Concomitant use of baclofen with antihypertensives is likely to increase the fall in blood pressure, therefore the dosage of the antihypertensive medication should be adjusted accordingly.

 

Antispastic agents, baclofen [2] ---> SPC of [2] of eMC

Baclofen should not be administered concomitantly with other antispastic agents, so as to avoid possible adverse reactions.

 

Anxiolytics, baclofen [2] ---> SPC of [2] of eMC

The concomitant administration of baclofen and other medications that have a suppressing effect on functions of the central nervous system can enhance the action of baclofen

 

Atenolol, baclofen

The co-administration may potentiate the hypotensive effect

 

Atenolol/chlortalidone [1], baclofen ---> SPC of [1] of eMC

Concomitant use of baclofen may increase the antihypertensive effect making dose adjustments necessary.

 

Atenolol/nifedipine, baclofen

Concurrent use of baclofen may increase the antihypertensive effect

 

Baclofen [1], barbiturates ---> SPC of [1] of eMC

The concomitant administration of baclofen and other medications that have a suppressing effect on functions of the central nervous system can enhance the action of baclofen

 

Baclofen, bendroflumethiazide

Concomitant use of bendroflumethiazide with baclofen may give an increased hypotensive effect.

 

Baclofen [1], benzodiazepines ---> SPC of [1] of eMC

The concomitant administration of baclofen and other medications that have a suppressing effect on functions of the central nervous system can enhance the action of baclofen

 

Baclofen, betablockers ---> SPC of [propranolol] of EMA

Drugs that induce postural hypotension may add their effects to that of beta-blockers.

 

Baclofen, betaxolol

The co-administration enhances the hypotensive effect

 

Baclofen, bisoprolol

The co-administration may increase the risk of hypotension

 

Baclofen [1], breast-feeding ---> SPC of [1] of eMC

Baclofen is excreted in breast milk. Baclofen should not be used during lactation, unless the advantages of the therapy for the mother outweigh the possible risks to the child.

 

Baclofen, buspirone

Baclofen may enhance any sedative effect.

 

Baclofen, carteolol

Increased antihypertensive effect

 

Baclofen, eplerenone [2] ---> SPC of [2] of eMC

Co-administration of eplerenone with baclofen may potentially increase antihypertensive effects and risk of postural hypotension.

 

Baclofen, fampridine [2] ---> SPC of [2] of EMA

Fampridine has been administered concomitantly with baclofen and no pharmacokinetic medicinal product interactions were observed.

 

Baclofen, fentanyl

Concomitant use of intrathecal baclofen and general anaesthetic agents (e. g. fentanyl, propofol) may increase the risk of cardiac disorders and convulsions

 

Baclofen, general anesthetics

Concomitant use of intrathecal baclofen and general anaesthetic agents (e. g. fentanyl, propofol) may increase the risk of cardiac disorders and convulsions

 

Baclofen, hydralazine [2] ---> SPC of [2] of eMC

Concurrent treatment of hydralazine with other antihypertensives may potentate the effects

 

Baclofen, hydrochlorothiazide

Increased antihypertensive effect

 

Baclofen, indapamide [2] ---> SPC of [2] of eMC

Increased antihypertensive effect.

 

Baclofen, isradipine [2] ---> SPC of [2] of eMC

As with all antihypertensives, concomitant treatment with oral baclofen is likely to further increase a possible fall in blood pressure. It may therefore be necessary to monitor blood pressure and adjust the dosage of the antihypertensive

 

Baclofen, levobunolol

The co-administration may enhance the hypotensive effect

 

Baclofen, levodopa/DOPA decarboxylase inhibitors

The co-administration may enhance the levodopa-associated adverse effects

 

Baclofen, lofepramine

An enhanced muscle relaxant effect occurs with baclofen when administered with lofepramine.

 

Baclofen, losartan [2] ---> SPC of [2] of eMC

Concomitant use of losartan with other substances inducing hypotension may increase the risk of hypotension.

 

Baclofen, losartan/hydrochlorothiazide [2] ---> SPC of [2] of eMC

Concomitant use of losartan with drugs that lower blood pressure, as main or side-effect, may increase the risk of hypotension.

 

Baclofen, memantin [2] ---> SPC of [2] of EMA

Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.

 

Baclofen, methyldopa

Concomitant use of methyldopa and baclofen may enhance the hypotensive effect.

 

Baclofen, midazolam [2] ---> SPC of [2] of EMA

Midazolam may cause potentiation of muscle relaxants, with increased CNS depressant effects.

 

Baclofen [1], morphine ---> SPC of [1] of eMC

When Baclofen is combined with morphine, a drop in blood pressure has occurred in one case. It cannot be excluded that in such cases respiratory disturbances or CNS disturbances may also occur.

 

Baclofen, muscle relaxants

The co-administration of baclofen with other muscle relaxants may cause mutual enhancement of effects

 

Baclofen, nebivolol [2] ---> SPC of [2] of eMC

Concomitant use of baclofen with antihypertensives is likely to increase the fall in blood pressure, therefore the dosage of the antihypertensive medication should be adjusted accordingly.

 

Baclofen [1], neuroleptics ---> SPC of [1] of eMC

The concomitant administration of baclofen and other medications that have a suppressing effect on functions of the central nervous system can enhance the action of baclofen

 

Baclofen, oxazepam

Enhanced sedative effect

 

Baclofen, perindopril [2] ---> SPC of [2] of eMC

Increased antihypertensive effect. Monitor blood pressure and adapt antihypertensive dosage if necessary.

 

Baclofen, phenobarbital

Concurrent administration of phenobarbital with other CNS depressants may lead to an additive CNS depressant effects

 

Baclofen, prazosin

Baclofen may enhance the hypotensive effect of prazosin

 

Baclofen [1], pregnancy ---> SPC of [1] of eMC

Baclofen should not be used during pregnancy, unless the advantages of the therapy for the mother outweigh the possible risks to the child.

 

Baclofen, propofol

Concomitant use of intrathecal baclofen and general anaesthetic agents (e. g. fentanyl, propofol) may increase the risk of cardiac disorders and convulsions

 

Baclofen, propranolol [2] ---> SPC of [2] of EMA

Drugs that induce postural hypotension may add their effects to that of beta-blockers.

 

Baclofen, ramipril [2] ---> SPC of [2] of eMC

Potentiation of the risk of hypotension is to be anticipated. Caution is recommended

 

Baclofen, sotalol

Increased antihypertensive effect

 

Baclofen, telmisartan [2] ---> SPC of [2] of EMA

Based on its pharmacological properties it can be expected that baclofen may potentiate the hypotensive effects of all antihypertensives including telmisartan

 

Baclofen, telmisartan/amlodipine [2] ---> SPC of [2] of EMA

Medicinal products with blood pressure lowering potential may potentiate the hypotensive effects of all antihypertensives

 

Baclofen, tiapride

Enhancement of CNS depressant effect

 

Baclofen, tizanidine [2] ---> SPC of [2] of eMC

Sedatives may enhance the sedative action of tizanidine.

 

Baclofen, tramadol [2] ---> SPC of [2] of eMC

Concomitant administration of tramadol with other centrally acting drugs may potentiate CNS depressant effects.

 

Baclofen, triamterene

The co-administration of triamterene and baclofen may enhance the hypotensive effect

 

Baclofen [1], tricyclic antidepressants ---> SPC of [1] of eMC

The co-administration of baclofen with tricyclic antidepressants can potentiate the effect of baclofen and as a result considerable muscle relaxation may occur.

 

Baclofen, trimipramine

Concomitant use increases muscle hypotonia

 

Baclofen, xipamide

The co-administration may potentiate the hypotensive effect

 

Baclofen, ziconotide [2] ---> SPC of [2] of EMA

An increased incidence of somnolence has been observed. The simultaneous use is discouraged.

 

 

           CONTRAINDICATIONS of Baclofen

            

           Baclofen must not be administered in case of:

           - hypersensitivity to the active substance or to any of the excipients

           - therapy-resistant epilepsy.

           Baclofen should be administered only into the subarachnoid space. Baclofen must not be administered by the intravenous, intramuscular, subcutaneous or epidural routes.

            

           http://www.medicines.org.uk/emc/






Baloxavir (Xofluza)

Antacids, baloxavir [2] ---> SmPC of [2] of EMA

Products that contain polyvalent cations may decrease plasma concentrations of baloxavir. Xofluza should not be taken with products that contain polyvalent cations

 

Baloxavir [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made whether to discontinue breast-feeding or to abstain from baloxavir marboxil therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Baloxavir [1], calcium ---> SmPC of [1] of EMA

Products that contain polyvalent cations may decrease plasma concentrations of baloxavir. Xofluza should not be taken with products that contain polyvalent cations

 

Baloxavir [1], fertility ---> SmPC of [1] of EMA

No effects on male or female fertility were observed in animal studies performed with baloxavir marboxil (see section 5.3).

 

Baloxavir [1], influenza vaccine ---> SmPC of [1] of EMA

Interaction studies with influenza vaccines and baloxavir marboxil have not been conducted. In studies of naturally acquired and experimental influenza, treatment with Xofluza did not impair the humoral antibody response to influenza infection.

 

Baloxavir [1], iron ---> SmPC of [1] of EMA

Products that contain polyvalent cations may decrease plasma concentrations of baloxavir. Xofluza should not be taken with products that contain polyvalent cations

 

Baloxavir [1], laxatives ---> SmPC of [1] of EMA

Products that contain polyvalent cations may decrease plasma concentrations of baloxavir. Xofluza should not be taken with products that contain polyvalent cations

 

Baloxavir [1], magnesium ---> SmPC of [1] of EMA

Products that contain polyvalent cations may decrease plasma concentrations of baloxavir. Xofluza should not be taken with products that contain polyvalent cations

 

Baloxavir [1], polyvalent cations ---> SmPC of [1] of EMA

Products that contain polyvalent cations may decrease plasma concentrations of baloxavir. Xofluza should not be taken with products that contain polyvalent cations

 

Baloxavir [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is preferable to avoid the use of Xofluza during pregnancy.

 

Baloxavir [1], selene ---> SmPC of [1] of EMA

Products that contain polyvalent cations may decrease plasma concentrations of baloxavir. Xofluza should not be taken with products that contain polyvalent cations

 

Baloxavir [1], zinc ---> SmPC of [1] of EMA

Products that contain polyvalent cations may decrease plasma concentrations of baloxavir. Xofluza should not be taken with products that contain polyvalent cations

  

 

            CONTRAINDICATIONS of Baloxavir (Xofluza)     

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

            https://www.ema.europa.eu/en/documents/product-information/xofluza-epar-product-information_en.pdf 02/06/2025 






Bambuterol

 

Antidiabetics, bambuterol

The co-administration may decrease the hypoglycemic effect of antidiabetic agent

 

Bambuterol [1], betablockers ---> SPC of [1] of eMC

Beta-receptor (including eye-drops), especially those which are non-selective, may partly or totally inhibit the effect of beta-stimulants. Bambuterol and non-selective beta-blockers should not normally be administered concurrently.

 

Bambuterol, biguanides

The co-administration may decrease the hypoglycemic effect of antidiabetic agent

 

Bambuterol [1], breast-feeding ---> SPC of [1] of eMC

A decision must be made whether to discontinue breast-feeding or to discontinue bambuterol therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Bambuterol [1], corticosteroids ---> SPC of [1] of eMC

Hypokalemia may result from beta2-agonist therapy and may be potentiated by concomitant treatment with corticosteroids

 

Bambuterol, digital glycosides

The co-administration may increase the risk of adverse drug reactions

 

Bambuterol, halogenated anaesthetics

The co-administration may increase the risk of arrhythmias

 

Bambuterol, hypokalemia

Concomitant hypokalaemic treatment may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists. Use with caution

 

Bambuterol, insulin

The co-administration may decrease the hypoglycemic effect of antidiabetic agent

 

Bambuterol [1], loop diuretics ---> SPC of [1] of eMC

Hypokalemia may result from beta2-agonist therapy and may be potentiated by concomitant treatment with diuretics

 

Bambuterol [1], metabolised by plasma cholinesterase ---> SPC of [1] of eMC

Bambuterol may interact with muscle relaxants metabolised by plasma cholinesterase due to the plasma cholinesterase is partly, but fully reversibly, inhibited by bambuterol.

 

Bambuterol, mivacurium

Drugs that may reduce plasma cholinesterase activity may also prolong the neuromuscular blocking action of mivacurium.

 

Bambuterol [1], non-selective betablockers ---> SPC of [1] of eMC

Beta-receptor (including eye-drops), especially those which are non-selective, may partly or totally inhibit the effect of beta-stimulants. Bambuterol and non-selective beta-blockers should not normally be administered concurrently.

 

Bambuterol [1], pregnancy ---> SPC of [1] of eMC

Caution is recommended during the first trimester of pregnancy. Beta-agonists should be used with caution at the end of pregnancy because of the tocolytic effect.

 

Bambuterol [1], succinylcholine ---> SPC of [1] of eMC

Bambuterol prolongs the muscle-relaxing effect of suxamethonium (succinylcholine). This is due to the fact that plasma cholinesterase, which inactivates suxamethonium, is partly inhibited by bambuterol.

 

Bambuterol, sulfonylureas

The co-administration may decrease the hypoglycemic effect of antidiabetic agent

 

Bambuterol [1], suxamethonium ---> SPC of [1] of eMC

Bambuterol prolongs the muscle-relaxing effect of suxamethonium (succinylcholine). This is due to the fact that plasma cholinesterase, which inactivates suxamethonium, is partly inhibited by bambuterol.

 

Bambuterol [1], sympathomimetics ---> SPC of [1] of eMC

Bambuterol should be used with caution in patients receiving other sympathomimetics.

 

Bambuterol [1], thiazides ---> SPC of [1] of eMC

Hypokalemia may result from beta2-agonist therapy and may be potentiated by concomitant treatment with diuretics

 

Bambuterol [1], xanthines ---> SPC of [1] of eMC

Hypokalemia may result from beta2-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives

 

Beta-adrenergic agonists, betablockers ---> SPC of [bambuterol] of eMC

Beta-blocking agents (including eye drops), especially the non-selective ones such as propranolol, may partially or totally inhibit the effect of beta-stimulants.

 

Beta-adrenergic agonists, non-selective betablockers ---> SPC of [bambuterol] of eMC

Beta-blocking agents (including eye drops), especially the non-selective ones such as propranolol, may partially or totally inhibit the effect of beta-stimulants.

 

Beta2-adrenergic agonists, steroids ---> SPC of [bambuterol] of eMC

Hypokalaemia may result from beta2-agonist therapy and may be potentiated by concomitant treatment with corticosteroids

 

Beta2-adrenergic agonists, thiazides ---> SPC of [bambuterol] of eMC

Hypokalaemia may result from beta2-agonist therapy and may be potentiated by concomitant treatment with diuretics

 

 

           CONTRAINDICATIONS of Bambuterol

            

           - Bambec tablets are contraindicated in patients with a history of hypersensitivity to any of their ingredients.

           - Bambec is presently not recommended for children due to limited clinical data in this age group.

            

           http://www.medicines.org.uk/emc/


 


              

 

Baricitinib (Olumiant)

Azathioprine, baricitinib [2] ---> SmPC of [2] of EMA

In rheumatoid arthritis and juvenile idiopathic arthritis, use of baricitinib with potent immunosuppressive medicinal products such as was limited in clinical studies, and a risk of additive immunosuppression cannot be excluded.

 

Baricitinib [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Baricitinib [1], cyclosporine ---> SmPC of [1] of EMA

In rheumatoid arthritis and juvenile idiopathic arthritis, use of baricitinib with potent immunosuppressive medicinal products such as was limited in clinical studies, and a risk of additive immunosuppression cannot be excluded.

 

Baricitinib [1], cyclosporine ---> SmPC of [1] of EMA

Coadministration of baricitinib with ciclosporin (Pgp/BCRP inhibitor) or methotrexate (substrate of several transporters including OATP1B1, OAT1, OAT3, BCRP, MRP2, MRP3, and MRP4) resulted in no clinically meaningful effects on baricitinib exposure.

 

Baricitinib [1], cytochrome P450 ---> SmPC of [1] of EMA

In vitro, baricitinib is a cytochrome P450 enzyme (CYP)3A4 substrate although less than 10 % of the dose is metabolised via oxidation.

 

Baricitinib [1], diclofenac ---> SmPC of [1] of EMA

Concomitant use of the OAT3 inhibitors ibuprofen and diclofenac may lead to increased exposure of baricitinib, however their inhibition potential of OAT3 is less compared to probenecid and thus a clinically relevant interaction is not expected.

 

Baricitinib [1], digoxin ---> SmPC of [1] of EMA

In clinical pharmacology studies there were no clinically meaningful effects on exposure when baricitinib was coadministered with digoxin (Pgp substrate) or methotrexate (substrate of several transporters).

 

Baricitinib [1], ethinyl estradiol ---> SmPC of [1] of EMA

In clinical pharmacology studies, coadministration of baricitinib with the CYP3A substrates simvastatin, ethinyl oestradiol, or levonorgestrel resulted in no clinically meaningful changes in the PK of these medicinal products.

 

Baricitinib [1], fertility ---> SmPC of [1] of EMA

Studies in animals suggest that treatment with baricitinib has the potential to decrease female fertility while on treatment, but there was no effect on male spermatogenesis (see section 5.3).

 

Baricitinib [1], fluconazole ---> SmPC of [1] of EMA

Coadministration of baricitinib with fluconazole (moderate CYP3A/CYP2C19/CYP2C9 inhibitor) or rifampicin (strong CYP3A inducer) resulted in no clinically meaningful changes to baricitinib exposure.

 

Baricitinib [1], ibuprofen ---> SmPC of [1] of EMA

Concomitant use of the OAT3 inhibitors ibuprofen and diclofenac may lead to increased exposure of baricitinib, however their inhibition potential of OAT3 is less compared to probenecid and thus a clinically relevant interaction is not expected.

 

Baricitinib [1], immunosuppressives ---> SmPC of [1] of EMA

In rheumatoid arthritis and juvenile idiopathic arthritis, use of baricitinib with potent immunosuppressive medicinal products such as was limited in clinical studies, and a risk of additive immunosuppression cannot be excluded.

 

Baricitinib [1], ketoconazole ---> SmPC of [1] of EMA

In clinical pharmacology studies, coadministration of baricitinib with ketoconazole (strong CYP3A inhibitor) resulted in no clinically meaningful effect on the PK of baricitinib.

 

Baricitinib [1], leflunomide ---> SmPC of [1] of EMA

The prodrug leflunomide rapidly converts to teriflunomide which is a weak OAT3 inhibitor and therefore may lead to an increase in baricitinib exposure.

 

Baricitinib [1], methotrexate ---> SmPC of [1] of EMA

Coadministration of baricitinib with ciclosporin (Pgp/BCRP inhibitor) or methotrexate (substrate of several transporters including OATP1B1, OAT1, OAT3, BCRP, MRP2, MRP3, and MRP4) resulted in no clinically meaningful effects on baricitinib exposure.

 

Baricitinib [1], OAT3 inhibitors ---> SmPC of [1] of EMA

Consequently, the recommended dose in patients taking OAT3 inhibitors with a strong inhibition potential, such as probenecid, is 2 mg once daily (see section 4.2).

 

Baricitinib [1], omeprazole ---> SmPC of [1] of EMA

Elevating gastric pH with omeprazole had no clinically significant effect on baricitinib exposure.

 

Baricitinib [1], pregnancy ---> SmPC of [1] of EMA

Baricitinib is contraindicated during pregnancy (see section 4.3). Women of childbearing potential have to use effective contraception during and for at least 1 week after treatment.

 

Baricitinib [1], probenecide ---> SmPC of [1] of EMA

In a clinical pharmacology study, dosing of probenecid (an OAT3 inhibitor with strong inhibition potential) resulted in approximately a 2-fold increase in AUC(0-inf) with no change in tmax or Cmax of baricitinib.

 

Baricitinib [1], rifampicin ---> SmPC of [1] of EMA

Coadministration of baricitinib with fluconazole (moderate CYP3A/CYP2C19/CYP2C9 inhibitor) or rifampicin (strong CYP3A inducer) resulted in no clinically meaningful changes to baricitinib exposure.

 

Baricitinib [1], simvastatine ---> SmPC of [1] of EMA

In clinical pharmacology studies, coadministration of baricitinib with the CYP3A substrates simvastatin, ethinyl oestradiol, or levonorgestrel resulted in no clinically meaningful changes in the PK of these medicinal products.

 

Baricitinib [1], tacrolimus ---> SmPC of [1] of EMA

In rheumatoid arthritis and juvenile idiopathic arthritis, use of baricitinib with potent immunosuppressive medicinal products such as was limited in clinical studies, and a risk of additive immunosuppression cannot be excluded.

 

Baricitinib [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

Use with live, attenuated vaccines during, or immediately prior to, Olumiant therapy is not recommended.

 

Baricitinib, cenobamate [2] ---> SmPC of [2] of EMA

In vitro studies have shown that cenobamate inhibits OAT3. Therefore, concomitant administration of cenobamate and medicinal products transported by OAT3 may result in higher exposure of these medicinal products.

 

 

 

            CONTRAINDICATIONS of Baricitinib (Olumiant)     

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Pregnancy (see section 4.6).   

 

            https://www.ema.europa.eu/en/documents/product-information/olumiant-epar-product-information_en.pdf 19/12/2025 

 





          

Barnidipine

 

Ability to drive, barnidipine

It should be taken into account that occasionally dizziness or vertigo may occur during treatment with hypotensive medicinal products

 

Alcohol, barnidipine

The co-administration may increase the antihypertensive effect. Alcohol consumption should be avoided

 

Antihypertensives, barnidipine

The co-administration of barnidipine with other antihypertensive may enhance the antihypertensive effect

 

Azole antifungals, barnidipine

The strong CYP3A4 inhibition may increase the plasma concentrations of barnidipine. Barnidipine should not be concomitantly prescribed with strong CYP3A4 inhibitors.

 

Barnidipine, breast-feeding

Breast-feeding is not recommended during the treatment with barnidipine

 

Barnidipine, carbamazepine

The enzymatic inductor may decrease the plasma levels of barnidipine. Caution is recommended

 

Barnidipine, cimetidine

The moderate CYP3A4 inhibition may increase the plasma concentrations of barnidipine. Caution is recommend with the concomitant use of barnidipine with weak CYP3A4 inhibitors

 

Barnidipine, clarithromycin

The strong CYP3A4 inhibition may increase the plasma concentrations of barnidipine. Barnidipine should not be concomitantly prescribed with strong CYP3A4 inhibitors.

 

Barnidipine, cyclosporine

The strong CYP3A4 inhibition may increase the plasma concentrations of barnidipine. Barnidipine should not be concomitantly prescribed with strong CYP3A4 inhibitors.

 

Barnidipine, enzyme inductors

The enzymatic inductor may decrease the plasma levels of barnidipine. Caution is recommended

 

Barnidipine, erythromycin

The strong CYP3A4 inhibition may increase the plasma concentrations of barnidipine. Barnidipine should not be concomitantly prescribed with strong CYP3A4 inhibitors.

 

Barnidipine, grapefruit juice

The barnidipine pharmacokinetic wasn't significant altered with the concomitant use of grapefruit juice, but a little effect was seen

 

Barnidipine, itraconazol

The strong CYP3A4 inhibition may increase the plasma concentrations of barnidipine. Barnidipine should not be concomitantly prescribed with strong CYP3A4 inhibitors.

 

Barnidipine, ketoconazole

The strong CYP3A4 inhibition may increase the plasma concentrations of barnidipine. Barnidipine should not be concomitantly prescribed with strong CYP3A4 inhibitors.

 

Barnidipine, moderate CYP3A4 inhibitors

The moderate CYP3A4 inhibition may increase the plasma concentrations of barnidipine. Caution is recommend with the concomitant use of barnidipine with weak CYP3A4 inhibitors

 

Barnidipine, phenytoin

The enzymatic inductor may decrease the plasma levels of barnidipine. Caution is recommended

 

Barnidipine, pregnancy

Should only be used during pregnancy if the expected benefits outweigh the potential risks.

 

Barnidipine, protease inhibitors

The strong CYP3A4 inhibition may increase the plasma concentrations of barnidipine. Barnidipine should not be concomitantly prescribed with strong CYP3A4 inhibitors.

 

Barnidipine, rifampicin

The enzymatic inductor may decrease the plasma levels of barnidipine. Caution is recommended

 

Barnidipine, strong CYP3A4 inductors

The strong CYP3A4 induction may decrease plasma levels of barnidipine.

 

Barnidipine, strong CYP3A4 inhibitors

The strong CYP3A4 inhibition may increase the plasma concentrations of barnidipine. Barnidipine should not be concomitantly prescribed with strong CYP3A4 inhibitors.

 

CYP3A4 inductors, barnidipine

The CYP3A4 induction may decrease plasma levels of barnidipine. Caution is recommend with the concomitant use of barnidipine with weak CYP3A4 inductors






Basiliximab (Simulect)

Azathioprine, basiliximab [2] ---> SmPC of [2] of EMA

The use of basiliximab in a triple therapy regimen including azathioprine or mycophenolate mofetil did not increase adverse events or infections in the basiliximab group as compared to placebo

 

Basiliximab [1], breast-feeding ---> SmPC of [1] of EMA

Simulect is contraindicated in pregnancy and lactation (see section 4.3). Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation and the suckling neonate exposed to basiliximab in breast milk.

 

Basiliximab [1], contraceptives ---> SmPC of [1] of EMA

Women of childbearing potential must use effective contraception during and up to 16 weeks after treatment.

 

Basiliximab [1], mycophenolate mofetil ---> SmPC of [1] of EMA

The use of basiliximab in a triple therapy regimen including azathioprine or mycophenolate mofetil did not increase adverse events or infections in the basiliximab group as compared to placebo

 

Basiliximab [1], pregnancy ---> SmPC of [1] of EMA

Simulect is contraindicated in pregnancy and lactation (see section 4.3). Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation and the suckling neonate exposed to basiliximab in breast milk.

 

Basiliximab [1], vaccinations ---> SmPC of [1] of EMA

The use of live attenuated vaccines should therefore be avoided in patients treated with Simulect. Inactivated vaccines may be administered to immunosuppressed patients

 

Basiliximab, imlifidase [2] ---> SmPC of [2] of EMA

Recommended time interval after administration of 0.25 mg/kg imlifidase: 4 days

 

 

             CONTRAINDICATIONS of Basiliximab (Simulect)            

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Pregnancy and lactation

              

             https://www.ema.europa.eu/en/documents/product-information/simulect-epar-product-information_en.pdf 19/12/2025


            



 


Bazedoxifene (Conbriza)

Ability to drive, bazedoxifene [2] ---> SmPC of [2] of EMA

Patients may experience visual symptoms such as visual acuity disturbance or blurred vision. If such symptoms occur, patients should avoid driving or use of machines that requires accurate visual perception until symptoms have resolved

 

Antacids, bazedoxifene [2] ---> SmPC of [2] of EMA

There were no significant pharmacokinetic interactions between bazedoxifene and antacids with aluminium

 

Atorvastatin, bazedoxifene [2] ---> SmPC of [2] of EMA

There were no significant pharmacokinetic interactions between bazedoxifene and atorvastatin

 

Azithromycin, bazedoxifene [2] ---> SmPC of [2] of EMA

There were no significant pharmacokinetic interactions between bazedoxifene and azithromycin

 

Bazedoxifene [1], breast-feeding ---> SmPC of [1] of EMA

It is not known whether bazedoxifene is excreted in human milk. CONBRIZA is only indicated for use in postmenopausal women and should not be used during breast-feeding

 

Bazedoxifene [1], carbamazepine ---> SmPC of [1] of EMA

The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce UGTs potentially leading to decreased systemic concentrations of bazedoxifene.

 

Bazedoxifene [1], cytochrome P450 ---> SmPC of [1] of EMA

Bazedoxifene undergoes little or no cytochrome P450 (CYP)-mediated metabolism. Bazedoxifene does not induce or inhibit the activities of major CYP isoenzymes.

 

Bazedoxifene [1], diazepam ---> SmPC of [1] of EMA

Based on in vitro bazedoxifene plasma protein-binding characteristics, interactions with warfarin, digoxin or diazepam are unlikely.

 

Bazedoxifene [1], digoxin ---> SmPC of [1] of EMA

Based on in vitro bazedoxifene plasma protein-binding characteristics, interactions with warfarin, digoxin or diazepam are unlikely.

 

Bazedoxifene [1], fertility ---> SmPC of [1] of EMA

Studies in rats have shown adverse effects on fertility (see section 5.3). The potential risk for humans is unknown.

 

Bazedoxifene [1], hormone-binding globulin ---> SmPC of [1] of EMA

Bazedoxifene increased hormone-binding globulin concentrations, including corticosteroid-binding globulin (CBG), sex hormone-binding globulin (SHBG) and thyroxine-binding globulin (TBG).

 

Bazedoxifene [1], ibuprofen ---> SmPC of [1] of EMA

There were no significant pharmacokinetic interactions between bazedoxifene and ibuprofen

 

Bazedoxifene [1], magnesium hydroxide ---> SmPC of [1] of EMA

There were no significant pharmacokinetic interactions between bazedoxifene and magnesium hydroxide

 

Bazedoxifene [1], phenobarbital ---> SmPC of [1] of EMA

The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce UGTs potentially leading to decreased systemic concentrations of bazedoxifene.

 

Bazedoxifene [1], phenytoin ---> SmPC of [1] of EMA

The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce UGTs potentially leading to decreased systemic concentrations of bazedoxifene.

 

Bazedoxifene [1], pregnancy ---> SmPC of [1] of EMA

CONBRIZA is only for use in postmenopausal women. It is contraindicated in women of child-bearing potential

 

Bazedoxifene [1], rifampicin ---> SmPC of [1] of EMA

The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce UGTs potentially leading to decreased systemic concentrations of bazedoxifene.

 

Bazedoxifene [1], strong glucuronidation inductors ---> SmPC of [1] of EMA

The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce UGTs potentially leading to decreased systemic concentrations of bazedoxifene.

 

Bazedoxifene [1], warfarin ---> SmPC of [1] of EMA

Based on in vitro bazedoxifene plasma protein-binding characteristics, interactions with warfarin, digoxin or diazepam are unlikely.

 

Bazedoxifene, ospemifene [2] ---> SmPC of [2] of EMA

The safety of using ospemifene concomitantly with oestrogens or other SERMS has not been studied and its concurrent use is not recommended.

 

 

             CONTRAINDICATIONS of Bazedoxifene (Conbriza)

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.   

             - CONBRIZA is only indicated for use in postmenopausal women. Bazedoxifene must not be taken by women of child-bearing potential              

             - Unexplained uterine bleeding.           

             - Patients with signs or symptoms of endometrial cancer; safety in this patient group has not been adequately studied.            

                          

             https://www.ema.europa.eu/en/documents/product-information/conbriza-epar-product-information_en.pdf 20/05/2025 





          

BCG intravesical

 

BCG intravesical [1], antibiotics ---> SPC of [1] of eMC

The anti-tumour activity may be influenced by concomitant therapy with antibiotics. It is recommended to postpone the intravesical instillation until the end of the antibiotic-treatment

 

BCG intravesical [1], antineoplastics ---> SPC of [1] of eMC

The co-administration may interfere with the development of the immune response and thus with the anti-tumor efficacy. The combination is not recommended

 

BCG intravesical [1], breast-feeding ---> SPC of [1] of eMC

BCG intravesical instillation for carcinoma of the bladder is contraindicated during lactation

 

BCG intravesical [1], ethambutol ---> SPC of [1] of eMC

The treatment with anti-tuberculosis drugs is contraindicated

 

BCG intravesical [1], immunosuppressives ---> SPC of [1] of eMC

The co-administration may interfere with the development of the immune response and thus with the anti-tumor efficacy. The combination is not recommended

 

BCG intravesical, infliximab [2] ---> SPC of [2] of EMA

The therapeutic infectious agents could result in clinical infections, including disseminated infections. The concurrent administration is not is recommended

 

BCG intravesical [1], isoniazid ---> SPC of [1] of eMC

The treatment with anti-tuberculosis drugs is contraindicated

 

BCG intravesical [1], para-aminosalicylic acid ---> SPC of [1] of eMC

The treatment with anti-tuberculosis drugs is contraindicated

 

BCG intravesical [1], pregnancy ---> SPC of [1] of eMC

BCG intravesical instillation for carcinoma of the bladder is contraindicated during pregnancy

 

BCG intravesical [1], radiotherapy ---> SPC of [1] of eMC

The co-administration may interfere with the development of the immune response and thus with the anti-tumor efficacy. The combination is not recommended

 

BCG intravesical [1], rifampicin ---> SPC of [1] of eMC

The treatment with anti-tuberculosis drugs is contraindicated

 

BCG intravesical [1], streptomycin ---> SPC of [1] of eMC

The treatment with anti-tuberculosis drugs is contraindicated

 

BCG intravesical [1], tuberculostatics ---> SPC of [1] of eMC

The treatment with anti-tuberculosis drugs is contraindicated

 

 

           CONTRAINDICATIONS of BCG intravesical

            

           - Urinary tract infections. Therapy with OncoTICE should be interrupted until the bacterial culture from urine becomes negative and therapy with antibiotics and/or urinary antiseptics is stopped.

           - Gross haematuria. In these cases OncoTICE therapy should be stopped or postponed until the haematuria has been successfully treated or has resolved.

           - In patients with a positive Tuberculin test, OncoTICE instillations are contra-indicated only if there is supplementary medical evidence for an active tuberculous infection.

           - Treatment with anti-tuberculosis drugs like streptomycin, para-amino-salicylic acid (PAS), isoniazid (INH), rifampicin and ethambutol.

           - Impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy.

           - Positive HIV serology.

           - Pregnancy and lactation.

            

           http://www.medicines.org.uk/emc/


 




Becaplermin (Regranex)

Becaplermin [1], breast-feeding ---> SPC of [1] of EMA

Should not be used during lactation

 

Becaplermin [1], pregnancy ---> SPC of [1] of EMA

Should not be used during pregnancy

 

 

            CONTRAINDICATIONS of Becaplermin (Regranex)          

            - Hypersensitivity to the active substance or to any of the excipients.

            - Any known malignancies

            - In patients with clinically infected ulcers.

             

            https://www.ema.europa.eu/en/documents/product-information/regranex-epar-product-information_en.pdf 15/08/2012 (withdrawn)

           




          

Beclometasone

 

Barbiturates, beclometasone

The enzymatic induction may increase the metabolism and decrease the plasma concentrations of corticosteroid

 

Beclometasone [1], breast–feeding –––> SPC of [1] of eMC

The administration of beclometasone during lactation is not recommended unless strictly indicated after a careful risk / benefit evaluation.

 

Beclometasone, furosemide

Diuretic effect antagonised (sodium retention) and increased risk of hypokalaemia.

 

Beclometasone, non–potassium–sparing diuretics

The hypokalaemic effect of diuretics may be potentiated by corticosteroids

 

Beclometasone, phenytoin

Phenytoin may decrease the plasma concentrations of corticosteroid

 

Beclometasone [1], pregnancy –––> SPC of [1] of eMC

Beclometasone should not be used in pregnancy, unless strictly indicated after a careful risk / benefit evaluation.

 

Beclometasone, rifampicin

Rifampicin enhances the corticosteroid metabolism and its therapeutic effects may be reduced. Therefore it may be necessary to adjust the dose of corticosteroid accordingly

 

Beclometasone, thiazides

Diuretic effect antagonised (sodium retention) and increased risk of hypokalaemia.

 

 

           CONTRAINDICATIONS of Beclometasone

            

           Clipper 5 mg gastro–resistant prolonged release tablets are contraindicated in patients with:

           – hypersensitivity to beclometasone dipropionate or to any of the excipients

           – tubercular, local mycotic and viral infections

            

           http://www.medicines.org.uk/emc/


 



Beclometasone/formoterol/glycopyrronium (Trimbow)

Alcohol, beclometasone/formoterol/glycopyrronium [2] ---> SmPC of [2] of EMA

L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.

 

Anticholinergics, beclometasone/formoterol/glycopyrronium [2] ---> SmPC of [2] of EMA

Due to the anticholinergic effect of glycopyrronium, the long-term co-administration of Trimbow with other anticholinergic-containing medicinal products is not recommended

 

Antihistamines, beclometasone/formoterol/glycopyrronium [2] ---> SmPC of [2] of EMA

Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias.

 

Beclometasone/formoterol/glycopyrronium [1], beta-adrenergic medicinal product ---> SmPC of [1] of EMA

Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects; therefore, caution is required when other beta-adrenergic medicinal products are prescribed concomitantly with formoterol.

 

Beclometasone/formoterol/glycopyrronium [1], betablockers ---> SmPC of [1] of EMA

Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects; therefore, caution is required when other beta-adrenergic medicinal products are prescribed concomitantly with formoterol.

 

Beclometasone/formoterol/glycopyrronium [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Trimbow therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mothers.

 

Beclometasone/formoterol/glycopyrronium [1], cobicistat ---> SmPC of [1] of EMA

Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids; however, the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded

 

Beclometasone/formoterol/glycopyrronium [1], corticosteroids ---> SmPC of [1] of EMA

Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists

 

Beclometasone/formoterol/glycopyrronium [1], digital glycosides ---> SmPC of [1] of EMA

Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.

 

Beclometasone/formoterol/glycopyrronium [1], disopyramide ---> SmPC of [1] of EMA

Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias.

 

Beclometasone/formoterol/glycopyrronium [1], disulfiram ---> SmPC of [1] of EMA

There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole.

 

Beclometasone/formoterol/glycopyrronium [1], diuretics ---> SmPC of [1] of EMA

Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists

 

Beclometasone/formoterol/glycopyrronium [1], fertility ---> SmPC of [1] of EMA

No specific studies have been performed with Trimbow with regard to the safety in human fertility. Animal studies have shown impairment of fertility (see section 5.3).

 

Beclometasone/formoterol/glycopyrronium [1], furazolidone ---> SmPC of [1] of EMA

Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions

 

Beclometasone/formoterol/glycopyrronium [1], halogenated hydrocarbon ---> SmPC of [1] of EMA

There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.

 

Beclometasone/formoterol/glycopyrronium [1], hypokalemia ---> SmPC of [1] of EMA

Hypokalaemia may be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics

 

Beclometasone/formoterol/glycopyrronium [1], levodopa ---> SmPC of [1] of EMA

L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.

 

Beclometasone/formoterol/glycopyrronium [1], metronidazole ---> SmPC of [1] of EMA

There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole.

 

Beclometasone/formoterol/glycopyrronium [1], non-selective betablockers ---> SmPC of [1] of EMA

Non-cardioselective beta-blockers (including eye drops) should be avoided in patients taking inhaled formoterol. If they are administered for compelling reasons, the effect of formoterol will be reduced or abolished.

 

Beclometasone/formoterol/glycopyrronium [1], oxytocin ---> SmPC of [1] of EMA

L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.

 

Beclometasone/formoterol/glycopyrronium [1], phenothiazines ---> SmPC of [1] of EMA

Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias.

 

Beclometasone/formoterol/glycopyrronium [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is preferable to avoid the use of Trimbow during pregnancy and during labour.

 

Beclometasone/formoterol/glycopyrronium [1], procainamide ---> SmPC of [1] of EMA

Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias.

 

Beclometasone/formoterol/glycopyrronium [1], procarbazine ---> SmPC of [1] of EMA

Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions

 

Beclometasone/formoterol/glycopyrronium [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias.

 

Beclometasone/formoterol/glycopyrronium [1], quinidine ---> SmPC of [1] of EMA

Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias.

 

Beclometasone/formoterol/glycopyrronium [1], renal excretion ---> SmPC of [1] of EMA

Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms

 

Beclometasone/formoterol/glycopyrronium [1], ritonavir ---> SmPC of [1] of EMA

Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids; however, the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded

 

Beclometasone/formoterol/glycopyrronium [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids; however, the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded

 

Beclometasone/formoterol/glycopyrronium [1], thyroxine ---> SmPC of [1] of EMA

L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.

 

Beclometasone/formoterol/glycopyrronium [1], tricyclic antidepressant ---> SmPC of [1] of EMA

Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias.

 

Beclometasone/formoterol/glycopyrronium [1], xanthines ---> SmPC of [1] of EMA

Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists

 

Beclometasone/formoterol/glycopyrronium, IMAOs [2] ---> SmPC of [2] of EMA

Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias.

 


CONTRAINDICATIONS of  Beclometasone/formoterol/glycopyrronium (Trimbow)

            - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

 

            https://www.ema.europa.eu/en/documents/product-information/trimbow-epar-product-information_en.pdf  05/11/2024 

 

Other trade names: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), Trydonis,

 





Bedaquiline (Sirturo)

Ability to drive, bedaquiline [2] ---> SmPC of [2] of EMA

Bedaquiline may have a minor influence on the ability to drive and use machines. Dizziness has been reported in some patients taking bedaquiline and should be considered when assessing a patient's ability to drive or operate machinery (see section 4.8).

 

Alcohol, bedaquiline [2] ---> SmPC of [2] of EMA

Other hepatotoxic medicinal products and alcohol should be avoided while on SIRTURO, especially in patients with diminished hepatic reserve.

 

Bedaquiline [1], breast-feeding ---> SmPC of [1] of EMA

Women who are treated with bedaquiline should not breastfeed.

 

Bedaquiline [1], carbamazepine ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], ciprofloxacin ---> SmPC of [1] of EMA

Co-administration of SIRTURO and CYP3A4 inhibitors does not have a clinically relevant effect on bedaquiline exposure. Therefore, the co-administration of SIRTURO and CYP3A4 inhibitors is allowed, and no dose adjustment is needed.

 

Bedaquiline [1], clarithromycin ---> SmPC of [1] of EMA

In healthy adults, 10 days of co-administration of another strong CYP3A4 inhibitor, clarithromycin, with single-dose bedaquiline increased the mean bedaquiline exposure (AUC) by 14% [90% CI (9; 19)].

 

Bedaquiline [1], clofazimine ---> SmPC of [1] of EMA

In the open-label Phase IIb trial, long-term co-administration of clofazimine and SIRTURO, as part of a combination therapy for up to 24 weeks, did not affect bedaquiline exposure.

 

Bedaquiline [1], cycloserine ---> SmPC of [1] of EMA

In a placebo-controlled clinical study in adults with TB, no major impact of co-administration of SIRTURO on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed.

 

Bedaquiline [1], CYP3A4 inductors ---> SmPC of [1] of EMA

Bedaquiline exposure may be reduced during co-administration with inducers of CYP3A4.This exposure difference was however not associated with a reduction in therapeutic effect.

 

Bedaquiline [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA

Bedaquiline exposure may be increased during co-administration with inhibitors of CYP3A4.

 

Bedaquiline [1], delamanid ---> SmPC of [1] of EMA

When bedaquiline is co-administered with other medicinal products that prolong the QTc interval (including clofazimine, delamanid, or fluoroquinolones), an additive effect on QT prolongation is expected (see section 4.5).

 

Bedaquiline [1], efavirenz ---> SmPC of [1] of EMA

Efavirenz is a moderate inducer of CYP3A activity and co-administration with bedaquiline may result in reduced bedaquiline exposure and loss of activity, and is, therefore, not recommended.

 

Bedaquiline [1], erythromycin ---> SmPC of [1] of EMA

Co-administration of SIRTURO and CYP3A4 inhibitors does not have a clinically relevant effect on bedaquiline exposure. Therefore, the co-administration of SIRTURO and CYP3A4 inhibitors is allowed, and no dose adjustment is needed.

 

Bedaquiline [1], ethambutol ---> SmPC of [1] of EMA

In a placebo-controlled clinical study in adults with TB, no major impact of co-administration of SIRTURO on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed.

 

Bedaquiline [1], etravirine ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], fertility ---> SmPC of [1] of EMA

No human data on the effect of bedaquiline on fertility are available. In female rats, there was no effect on mating or fertility with bedaquiline treatment, however some effects were observed in male rats (see section 5.3).

 

Bedaquiline [1], fluconazole ---> SmPC of [1] of EMA

Co-administration of SIRTURO and CYP3A4 inhibitors does not have a clinically relevant effect on bedaquiline exposure. Therefore, the co-administration of SIRTURO and CYP3A4 inhibitors is allowed, and no dose adjustment is needed.

 

Bedaquiline [1], fluoroquinolone antibiotics that have a potential for significant QT prolongation ---> SmPC of [1

Bedaquiline treatment initiation is not recommended in patients treated with fluoroquinolone antibiotics that have a potential for significant QT prolongation, unless the benefits of bedaquiline are considered to outweigh the potential risks

 

Bedaquiline [1], fluoroquinolones ---> SmPC of [1] of EMA

When bedaquiline is co-administered with other medicinal products that prolong the QTc interval (including clofazimine, delamanid, or fluoroquinolones), an additive effect on QT prolongation is expected (see section 4.5).

 

Bedaquiline [1], foods ---> SmPC of [1] of EMA

SIRTURO should be taken orally with food, as administration with food increases oral bioavailability by about 2-fold. SIRTURO tablets should be swallowed whole with water.

 

Bedaquiline [1], hepatotoxic drugs ---> SmPC of [1] of EMA

Other hepatotoxic medicinal products and alcohol should be avoided while on SIRTURO, especially in patients with diminished hepatic reserve.

 

Bedaquiline [1], isoniazid ---> SmPC of [1] of EMA

The short-term coadministration of bedaquiline with isoniazid/pyrazinamide in healthy subjects did not result in clinically relevant changes in the exposure (AUC) to bedaquiline, isoniazid or pyrazinamide. No dose-adjustment is required

 

Bedaquiline [1], kanamycin ---> SmPC of [1] of EMA

In a placebo-controlled clinical study in adults with TB, no major impact of co-administration of SIRTURO on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed.

 

Bedaquiline [1], ketoconazole ---> SmPC of [1] of EMA

The short-term co-administration of bedaquiline and ketoconazole (strong CYP3A4 inhibitor) in healthy adults increased the mean bedaquiline exposure (AUC) by 22% [90% CI (12; 32)].

 

Bedaquiline [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA

Co-administration of SIRTURO and CYP3A4 inhibitors does not have a clinically relevant effect on bedaquiline exposure. Therefore, the co-administration of SIRTURO and CYP3A4 inhibitors is allowed, and no dose adjustment is needed.

 

Bedaquiline [1], moxifloxacin ---> SmPC of [1] of EMA

Bedaquiline treatment initiation is not recommended in patients treated with fluoroquinolone antibiotics that have a potential for significant QT prolongation, unless the benefits of bedaquiline are considered to outweigh the potential risks

 

Bedaquiline [1], nevirapine ---> SmPC of [1] of EMA

Co-administration of single-dose bedaquiline and multiple-dose nevirapine did not result in clinically relevant changes in the exposure to bedaquiline.

 

Bedaquiline [1], ofloxacin ---> SmPC of [1] of EMA

In a placebo-controlled clinical study in adults with TB, no major impact of co-administration of SIRTURO on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed.

 

Bedaquiline [1], phenobarbital ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], phenytoin ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is recommended to avoid the use of Sirturo during pregnancy unless the benefit of therapy is considered to outweigh the risks.

 

Bedaquiline [1], pyrazinamide ---> SmPC of [1] of EMA

In a placebo-controlled clinical study in adults with TB, no major impact of co-administration of SIRTURO on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed.

 

Bedaquiline [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

SIRTURO may prolong the QT interval. An electrocardiogram should be obtained before initiation of treatment with SIRTURO and at least monthly after starting treatment to monitor the QTc interval.

 

Bedaquiline [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Serum potassium, calcium, and magnesium should be obtained at baseline and corrected if abnormal. Follow-up monitoring of electrolytes should be performed if QT prolongation is detected (see sections 4.5 and 4.8).

 

Bedaquiline [1], rifabutin ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], rifamicyn ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], rifampicin ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], rifapentine ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], ritonavir ---> SmPC of [1] of EMA

Co-administration of SIRTURO and CYP3A4 inhibitors does not have a clinically relevant effect on bedaquiline exposure. Therefore, the co-administration of SIRTURO and CYP3A4 inhibitors is allowed, and no dose adjustment is needed.

 

Bedaquiline [1], sparfloxacin ---> SmPC of [1] of EMA

Bedaquiline treatment initiation is not recommended in patients treated with fluoroquinolone antibiotics that have a potential for significant QT prolongation, unless the benefits of bedaquiline are considered to outweigh the potential risks

 

Bedaquiline [1], St. John's wort ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

Due to the possibility of a reduction of the therapeutic effect of bedaquiline due to a decrease in systemic exposure, co-administration of bedaquiline and moderate or strong CYP3A4 inducers used systemically should be avoided.

 

Bedaquiline [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Co-administration of SIRTURO and CYP3A4 inhibitors does not have a clinically relevant effect on bedaquiline exposure. Therefore, the co-administration of SIRTURO and CYP3A4 inhibitors is allowed, and no dose adjustment is needed.

 

Bedaquiline [1], syncope ---> SmPC of [1] of EMA

If syncope occurs, an electrocardiogram should be obtained to detect any QT prolongation.

 

Bedaquiline, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA

Long-term co-administration of SIRTURO as part of a combination therapy and lopinavir/ritonavir in patients co-infected with HIV resulted in a mild increase in mean bedaquiline exposure at Week 24. No dose adjustment is required.

 

Bedaquiline, simeprevir [2] ---> SmPC of [2] of EMA

No clinically relevant drug-drug interaction is expected. No dose adjustment is required

 

 

 

            CONTRAINDICATIONS of Bedaquiline (Sirturo)  

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

            https://www.ema.europa.eu/en/documents/product-information/sirturo-epar-product-information_en.pdf 24/11/2025 

 






Belantamab mafodotin (Blenrep)

Ability to drive, belantamab mafodotin [2] ---> SmPC of [2] of EMA

Patients should be advised to use caution when driving or operating machines as BLENREP may affect their vision.

 

Belantamab mafodotin [1], breast-feeding ---> SmPC of [1] of EMA

Women should be advised to discontinue breast-feeding prior to initiating treatment with BLENREP and for 3 months after the last dose.

 

Belantamab mafodotin [1], fertility ---> SmPC of [1] of EMA

Based on findings in animals and the mechanism of action, belantamab mafodotin may impair fertility in females and males of reproductive potential

 

Belantamab mafodotin [1], medicinal products ---> SmPC of [1] of EMA

Based on available in vitro and clinical data, there is a low risk of pharmacokinetic or pharmacodynamic drug interactions for belantamab mafodotin (see section 5.2).

 

Belantamab mafodotin [1], men ---> SmPC of [1] of EMA

Men with female partners of child-bearing potential should use effective contraception during treatment with BLENREP and for 6 months after the last dose.

 

Belantamab mafodotin [1], men ---> SmPC of [1] of EMA

Men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.

 

Belantamab mafodotin [1], pregnancy ---> SmPC of [1] of EMA

BLENREP should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus. If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the foetus.

 

Belantamab mafodotin [1], women of childbearing potential ---> SmPC of [1] of EMA

The pregnancy status of child-bearing women should be verified prior to initiating therapy with BLENREP. Women of child-bearing potential should use effective contraception during treatment with BLENREP and for 4 months after the last dose.

 

Belantamab mafodotin [1], women of childbearing potential ---> SmPC of [1] of EMA

Therefore, women of childbearing potential who may desire children in the future should be counselled prior to therapy regarding the option of having eggs frozen before treatment.

 

 

 

            CONTRAINDICATIONS of Belantamab mafodotin (Blenrep)         

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

            https://www.ema.europa.eu/en/documents/product-information/blenrep-epar-product-information_en.pdf 13/03/2024 (withdraw)     


 


Belatacept (Nulojix)

Ability to drive, belatacept [2] ---> SmPC of [2] of EMA

Belatacept has a minor influence on the ability to drive and use machines since it may cause fatigue, malaise and/or nausea.

 

Belatacept [1], breast-feeding ---> SmPC of [1] of EMA

Women should not breast-feed while in treatment with a belatacept-based regimen.

 

Belatacept [1], metabolized by cytochrome P450 ---> SmPC of [1] of EMA

Belatacept is not expected to affect cytochrome P450 enzymes via effects on cytokines.

 

Belatacept [1], mycophenolate mofetil ---> SmPC of [1] of EMA

Belatacept is not expected to interrupt the enterohepatic recirculation of MPA. At a given dose of MMF, MPA exposure is approximately 40% higher with belatacept coadministration than with ciclosporin coadministration.

 

Belatacept [1], pregnancy ---> SmPC of [1] of EMA

Belatacept should not be used in pregnant women unless clearly necessary.

 

Belatacept [1], vaccinations ---> SmPC of [1] of EMA

Immunosuppressant therapy may affect response to vaccination. Therefore, during treatment with belatacept, vaccinations may be less effective.

 

Belatacept [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

Immunosuppressant therapy may affect response to vaccination. Therefore, during treatment with belatacept, vaccinations may be less effective. The use of live vaccines should be avoided

 

Belatacept, imlifidase [2] ---> SmPC of [2] of EMA

Recommended time interval after administration of 0.25 mg/kg imlifidase: 1 week

 

 

             CONTRAINDICATIONS of Belatacept (Nulojix)                

             - Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.            

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

                          

             https://www.ema.europa.eu/en/documents/product-information/nulojix-epar-product-information_en.pdf. 14/03/2019      

                        






Belimumab (Benlysta)

Ability to drive, belimumab [2] ---> SmPC of [2] of EMA

The clinical status of the subject and the adverse reaction profile of Benlysta should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.

 

Belimumab [1], breast-feeding ---> SmPC of [1] of EMA

It is recommended that a decision should be made whether to discontinue breast-feeding or to discontinue Benlysta therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Belimumab [1], CYP substrates with a narrow therapeutic index ---> SmPC of [1] of EMA

On initiation or discontinuation of belimumab, therapeutic monitoring should be considered for patients being treated with CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin).

 

Belimumab [1], fertility ---> SmPC of [1] of EMA

There are no data on the effects of belimumab on human fertility. Effects on male and female fertility have not been formally evaluated in animal studies (see section 5.3).

 

Belimumab [1], pregnancy ---> SmPC of [1] of EMA

Benlysta should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus.

 

Belimumab [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

Live vaccines should not be given for 30 days before, or concurrently with Benlysta, as clinical safety has not been established.

 

Belimumab [1], warfarin ---> SmPC of [1] of EMA

On initiation or discontinuation of belimumab, therapeutic monitoring should be considered for patients being treated with CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin).

 

Belimumab [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential must use effective contraception during Benlysta treatment and for at least 4 months after the last treatment.

 

 

             CONTRAINDICATIONS of Belimumab (Benlysta)           

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

              

             https://www.ema.europa.eu/en/documents/product-information/benlysta-epar-product-information_en.pdf 07/10/2025








Belzutifan (Welireg)

Ability to drive, belzutifan [2] ---> SmPC of [2] of EMA

Belzutifan has minor influence on the ability to drive and use machines. Dizziness and fatigue may occur following administration of belzutifan (see section 4.8).

 

Belzutifan [1], breast-feeding ---> SmPC of [1] of EMA

Because of the potential for serious adverse reactions in breast-fed children, advise women not to breast-feed during treatment with belzutifan and for 1 week after the last dose.

 

Belzutifan [1], CYP2B6 substrates ---> SmPC of [1] of EMA

Co-administration with belzutifan may result in a clinically relevant decrease in the plasma concentration of sensitive CYP2B6 and/or CYP2C8 substrates.

 

Belzutifan [1], CYP2C19 inhibitors ---> SmPC of [1] of EMA

Coadministration of belzutifan with inhibitors of UGT2B17 or CYP2C19 increases plasma exposures of belzutifan, which may increase the incidence and severity of adverse reactions of belzutifan.

 

Belzutifan [1], CYP2C8 substrates ---> SmPC of [1] of EMA

Co-administration with belzutifan may result in a clinically relevant decrease in the plasma concentration of sensitive CYP2B6 and/or CYP2C8 substrates.

 

Belzutifan [1], CYP3A4 substrates ---> SmPC of [1] of EMA

Coadministration of belzutifan with CYP3A4 substrates, including hormonal contraceptives, decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates.

 

Belzutifan [1], dual UGT2B17 and CYP2C19 poor metabolisers ---> SmPC of [1] of EMA

The magnitude of this decrease may be more pronounced in patients who are dual UGT2B17 and CYP2C19 poor metabolisers (see section 5.2).

 

Belzutifan [1], fertility ---> SmPC of [1] of EMA

Based on findings in animals, belzutifan may impair fertility in males and females of reproductive potential (see section 5.3). Patients should be advised of this potential risk. The reversibility of the effect on fertility is unknown.

 

Belzutifan [1], foods ---> SmPC of [1] of EMA

The tablets should be swallowed whole and may be taken with or without food. Tablets should not be split, crushed or chewed, as it is not known whether this impacts absorption of belzutifan.

 

Belzutifan [1], hormonal contraceptives ---> SmPC of [1] of EMA

Coadministration of belzutifan with CYP3A4 substrates, including hormonal contraceptives, decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates.

 

Belzutifan [1], MATE1 inhibitors ---> SmPC of [1] of EMA

Based on in vitro data, MATE- 2K inhibition by belzutifan is expected at clinically relevant exposures, and inhibition of MATE1 cannot be excluded.

 

Belzutifan [1], midazolam ---> SmPC of [1] of EMA

In a clinical study, repeat administration of belzutifan 120 mg daily resulted in a 40% reduction in midazolam area under the curve (AUC), an effect consistent with a weak CYP3A4 inducer.

 

Belzutifan [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA

Belzutifan may exhibit moderate CYP3A4 induction in patients who have higher belzutifan plasma exposures (see section 5.2).

 

Belzutifan [1], pregnancy ---> SmPC of [1] of EMA

Studies in animals have shown reproductive toxicity (see section 5.3). Belzutifan is contraindicated during pregnancy (see section 4.3). If pregnancy occurs during treatment with belzutifan, treatment should be discontinued.

 

Belzutifan [1], sensitive substrates of CYP3A4 ---> SmPC of [1] of EMA

Coadministration of belzutifan with sensitive CYP3A4 substrates, for which minimal decrease in concentration may lead to therapeutic failures of the substrate should be avoided.

 

Belzutifan [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential have to use highly effective contraceptive methods during treatment with belzutifan and for at least 1 week after the last dose due to the potential risk to the foetus

 

Belzutifan [1], women of childbearing potential ---> SmPC of [1] of EMA

Coadministration of belzutifan with hormonal contraceptives may lead to contraceptive failure (see sections 4.4 and 4.6) or an increase in breakthrough bleeding.

 

 

 

            CONTRAINDICATIONS of Belzutifan (Welireg)   

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Pregnancy in patients with VHL disease-associated tumours (see section 4.6).  

 

            https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf 13/01/2026 





          

Bemiparin

 

Acetylsalicylic acid, bemiparin

The concomitant administration of bemiparin and acetyl salicylic acid is not advisable. Increased risk of bleeding.

 

Anticoagulants, bemiparin

The concomitant administration of bemiparin and anticoagulants is not advisable. Increased risk of bleeding.

 

Bemiparin, breast-feeding

Where it is necessary for lactating mothers to receive bemiparin, they should be advised to avoid breast-feeding.

 

Bemiparin, clopidogrel

The concomitant administration of bemiparin and clopidogrel is not advisable. Increased risk of bleeding.

 

Bemiparin, dextran

The concomitant administration of bemiparin and dextran is not advisable. Increased risk of bleeding.

 

Bemiparin, glucocorticoids

The concomitant administration of bemiparin and systemic glucocorticoids is not advisable. Increased risk of bleeding.

 

Bemiparin, hyperkalemia

Medicinal products that increase the serum potassium concentration should only be taken concomitantly under especially careful medical supervision

 

Bemiparin, nitroglycerine

Interaction of heparin with intravenous nitroglycerine (which can result in a decrease in efficacy) cannot be ruled out for bemiparin.

 

Bemiparin, nonsteroidal antiinflammatory drugs

The concomitant administration of bemiparin and NSAIDs is not advisable. Increased risk of bleeding.

 

Bemiparin, platelet aggregation inhibitors

The concomitant administration of bemiparin and platelet inhibitors is not advisable. Increased risk of bleeding.

 

Bemiparin, pregnancy

For bemiparin, no clinical data on exposed pregnancies are available. Therefore, caution should be exercised when prescribing to pregnant women.

 

Bemiparin, salicylates

The concomitant administration of bemiparin and salicylates is not advisable. Increased risk of bleeding.

 

Bemiparin, ticlopidine

The concomitant administration of bemiparin and ticlopidine is not advisable. Increased risk of bleeding.

 

Bemiparin, vitamin K antagonists

The concomitant administration of bemiparin and vitamin K antagonists is not advisable. Increased risk of bleeding.


 

 



Bempedoic acid (Nilemdo)

Asunaprevir, bempedoic acid [2] ---> SmPC of [2] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Atorvastatin, bempedoic acid [2] ---> SmPC of [2] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], bosentan ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], breast-feeding ---> SmPC of [1] of EMA

Because of the potential for serious adverse reactions, women taking Nilemdo should not breast- feed their infants. Nilemdo is contraindicated during breast-feeding

 

Bempedoic acid [1], ethinylestradiol/norethindrone ---> SmPC of [1] of EMA

Bempedoic acid had no effect on the pharmacokinetics of oral contraceptive norethindrone/ethinyl estradiol.

 

Bempedoic acid [1], ezetimibe ---> SmPC of [1] of EMA

Total ezetimibe (ezetimibe and its glucuronide form) and ezetimibe glucuronide AUC and Cmax increased approximately 1.6- and 1.8-fold, respectively. These elevations are not clinically meaningful and do not impact dosing recommendations.

 

Bempedoic acid [1], fertility ---> SmPC of [1] of EMA

No data on the effect of Nilemdo on human fertility are available. Based on animal studies, no effect on reproduction or fertility is expected with Nilemdo (see section 5.3).

 

Bempedoic acid [1], fimasartan ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], fluvastatin ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], glecaprevir ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], grazoprevir ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], metformin ---> SmPC of [1] of EMA

Bempedoic acid had no effect on the pharmacokinetics or pharmacodynamics of metformin.

 

Bempedoic acid [1], OAT2 substrates ---> SmPC of [1] of EMA

Inhibition of OAT2 by bempedoic acid may also potentially increase plasma concentrations of medicinal products that are substrates of OAT2.

 

Bempedoic acid [1], pitavastatin ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], pravastatine ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], pregnancy ---> SmPC of [1] of EMA

Nilemdo is contraindicated during pregnancy

 

Bempedoic acid [1], pregnancy ---> SmPC of [1] of EMA

Nilemdo may cause foetal harm when administered to pregnant women. Nilemdo should be discontinued prior to conception or as soon as pregnancy is recognized (see section 4.3).

 

Bempedoic acid [1], probenecide ---> SmPC of [1] of EMA

Administration of bempedoic acid with steady-state probenecid resulted in an increase in bempedoic acid area under the curve and in bempedoic acid active metabolite. These elevations are not clinically meaningful and do not impact dosing recommendations.

 

Bempedoic acid [1], rosuvastatin ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], simvastatine ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], statins ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], voxilaprevir ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential should use effective contraception during treatment (see section 4.4).

 

 

 

            CONTRAINDICATIONS of Bempedoic acid (Nilemdo)      

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Pregnancy (see section 4.6).   

            - Breast-feeding (see section 4.6).         

            - Concomitant use with simvastatin > 40 mg daily (see sections 4.2, 4.4, and 4.5).             

 

            https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf 20/06/2024             

 


 


Bempedoic acid/ezetimibe (Nustendi)

Ability to drive, bempedoic acid/ezetimibe [2] ---> SmPC of [2] of EMA

When driving vehicles or using machines, it should be taken into account that dizziness has been reported with bempedoic acid and ezetimibe

 

Asunaprevir, bempedoic acid/ezetimibe [2] ---> SmPC of [2] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Atorvastatin, bempedoic acid/ezetimibe [2] ---> SmPC of [2] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], bosentan ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], breast-feeding ---> SmPC of [1] of EMA

Because of the potential for serious adverse reactions, women taking Nustendi should not breast- feed their infants. Nustendi is contraindicated during breast-feeding

 

Bempedoic acid/ezetimibe [1], cholestyramine ---> SmPC of [1] of EMA

The incremental low-density lipoprotein cholesterol (LDL-C) reduction due to adding Nustendi to cholestyramine may be lessened by this interaction

 

Bempedoic acid/ezetimibe [1], coumarin anticoagulants ---> SmPC of [1] of EMA

If Nustendi is added to warfarin, other coumarin anticoagulants, or fluindione, INR should be appropriately monitored

 

Bempedoic acid/ezetimibe [1], cyclosporine ---> SmPC of [1] of EMA

Caution should be exercised when initiating Nustendi in the setting of ciclosporin. Ciclosporin concentrations should be monitored in patients receiving Nustendi and ciclosporin (see section 4.4).

 

Bempedoic acid/ezetimibe [1], dapsone ---> SmPC of [1] of EMA

In clinical interaction studies, ezetimibe had no effect on the pharmacokinetics of dapsone, dextromethorphan, digoxin, glipizide, tolbutamide, or midazolam, during coadministration.

 

Bempedoic acid/ezetimibe [1], dextromethorphan ---> SmPC of [1] of EMA

In clinical interaction studies, ezetimibe had no effect on the pharmacokinetics of dapsone, dextromethorphan, digoxin, glipizide, tolbutamide, or midazolam, during coadministration.

 

Bempedoic acid/ezetimibe [1], digoxin ---> SmPC of [1] of EMA

In clinical interaction studies, ezetimibe had no effect on the pharmacokinetics of dapsone, dextromethorphan, digoxin, glipizide, tolbutamide, or midazolam, during coadministration.

 

Bempedoic acid/ezetimibe [1], ethinyl estradiol/levonorgestrel ---> SmPC of [1] of EMA

In clinical interaction studies, ezetimibe had no effect on the pharmacokinetics of oral contraceptives ethinyl estradiol and levonorgestrel.

 

Bempedoic acid/ezetimibe [1], ethinylestradiol/norethindrone ---> SmPC of [1] of EMA

Bempedoic acid had no effect on the pharmacokinetics of oral contraceptive norethindrone/ethinyl estradiol.

 

Bempedoic acid/ezetimibe [1], fenofibrate ---> SmPC of [1] of EMA

Concomitant fenofibrate or gemfibrozil administration modestly increased total ezetimibe concentrations (approximately 1.5- and 1.7-fold, respectively). Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis.

 

Bempedoic acid/ezetimibe [1], fertility ---> SmPC of [1] of EMA

No data on the effect of Nustendi on human fertility are available. Based on animal studies, no effect on reproduction or fertility is expected with Nustendi (see section 5.3).

 

Bempedoic acid/ezetimibe [1], fimasartan ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], fluindione ---> SmPC of [1] of EMA

However, there have been postmarketing reports of increased INR in patients who had ezetimibe added to warfarin or fluindione.

 

Bempedoic acid/ezetimibe [1], fluvastatin ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], gemfibrozil ---> SmPC of [1] of EMA

Concomitant fenofibrate or gemfibrozil administration modestly increased total ezetimibe concentrations (approximately 1.5- and 1.7-fold, respectively).

 

Bempedoic acid/ezetimibe [1], glecaprevir ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], glipizide ---> SmPC of [1] of EMA

In clinical interaction studies, ezetimibe had no effect on the pharmacokinetics of dapsone, dextromethorphan, digoxin, glipizide, tolbutamide, or midazolam, during coadministration.

 

Bempedoic acid/ezetimibe [1], grazoprevir ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], metformin ---> SmPC of [1] of EMA

Bempedoic acid had no effect on the pharmacokinetics or pharmacodynamics of metformin.

 

Bempedoic acid/ezetimibe [1], midazolam ---> SmPC of [1] of EMA

In clinical interaction studies, ezetimibe had no effect on the pharmacokinetics of dapsone, dextromethorphan, digoxin, glipizide, tolbutamide, or midazolam, during coadministration.

 

Bempedoic acid/ezetimibe [1], OAT2 inhibitors ---> SmPC of [1] of EMA

Inhibition of OAT2 by bempedoic acid may also potentially increase plasma concentrations of medicinal products that are substrates of OAT2.

 

Bempedoic acid/ezetimibe [1], OATP1B1 substrates ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], OATP1B3 substrates ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], pitavastatin ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], pravastatine ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], pregnancy ---> SmPC of [1] of EMA

Nustendi is contraindicated during pregnancy

 

Bempedoic acid/ezetimibe [1], pregnancy ---> SmPC of [1] of EMA

Nustendi may cause foetal harm when administered to pregnant women. Nustendi should be discontinued prior to conception or as soon as pregnancy is recognized (see section

 

Bempedoic acid/ezetimibe [1], probenecide ---> SmPC of [1] of EMA

These elevations are not clinically meaningful and do not impact dosing recommendations.

 

Bempedoic acid/ezetimibe [1], rosuvastatin ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], simvastatine ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], statins ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], tolbutamide ---> SmPC of [1] of EMA

In clinical interaction studies, ezetimibe had no effect on the pharmacokinetics of dapsone, dextromethorphan, digoxin, glipizide, tolbutamide, or midazolam, during coadministration.

 

Bempedoic acid/ezetimibe [1], voxilaprevir ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], warfarin ---> SmPC of [1] of EMA

However, there have been postmarketing reports of increased INR in patients who had ezetimibe added to warfarin or fluindione.

 

Bempedoic acid/ezetimibe [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential should use effective contraception during treatment (see section 4.4).

 

Bempedoic acid/ezetimibe, cyclosporine [2] ---> SmPC of [2] of EMA

Ciclosporin concentrations should be monitored in patients receiving Nustendi and ciclosporin

 

 

 

            CONTRAINDICATIONS of Bempedoic acid/ezetimibe (Nustendi)    

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Pregnancy (see section 4.6).   

            - Breast-feeding (see section 4.6).         

            - Concomitant use with simvastatin > 40 mg daily (see sections 4.2, 4.4, and 4.5).             

            - Nustendi coadministered with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.    

            - When Nustendi is coadministered with a statin, please refer to the summary of product characteristics (SmPC) for that particular statin therapy.  

 

            https://www.ema.europa.eu/en/documents/product-information/nustendi-epar-product-information_en.pdf 20/06/2024             

 


           

 

Benazepril

 

NSAID, benazepril

Concomitant use of NSAIDs and ACE inhibitors may increase the risk of renal failure and hyperkalemia.

 

Ability to drive, benazepril

As with other antihypertensives, the ability to drive and use machines may be reduced

 

Alcohol, benazepril

Enhancement of hypotension and effect of alcohol

 

Aliskiren [1], benazepril ---> SPC of [1] of EMA

The combination of ACE inhibitors with aliskiren is contraindicated in diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) and is not recommended in other patients

 

Allopurinol, benazepril

Increased blood count alterations

 

Amiloride, benazepril

Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.

 

Antihypertensives, benazepril

Benazepril may enhance the hypotensive effect of other antihypertensive drugs

 

Aurothiomalate, benazepril

Nitritoid reactions following injectable gold have been reported more frequently in patients receiving ACE inhibitor therapy.

 

Benazepril, breast-feeding

The use of benazepril in breast-feeding is not recommended for preterm infants and for the first few weeks after delivery, due to the hypothetical risk of cardiovascular and renal effects and because there is not enough clinical experience

 

Benazepril, corticosteroids

Increased blood count alterations

 

Benazepril, cyclosporine

Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.

 

Benazepril, cytostatics

Increased blood count alterations

 

Benazepril, dihydropyrimidine dehydrogenase inhibitors 4

The co-administration of ACE inhibitors and dipeptidyl peptidase 4 inhibitors (e. g. vildagliptin) may increase the risk of angioedema

 

Benazepril, diuretics

Patients on diuretics, and especially those who are volume and/or salt depleted, may experience excessive reduction in blood pressure after initiation of therapy with an ACE inhibitor.

 

Benazepril, erythropoietin

The co-administration of ACE inhibitors may decrease the response to erythropoietin

 

Benazepril, gold

Nitritoid reactions following injectable gold have been reported more frequently in patients receiving ACE inhibitor therapy.

 

Benazepril, heparin

Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.

 

Benazepril, hyperkalemia

Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.

 

Benazepril, immunosuppressives

Increased blood count alterations

 

Benazepril, indometacin

It has been shown that the antihypertensive effect of ACE inhibitors may be decreased with the co-administration of indometacin

 

Benazepril, insulin

Concomitant treatment with ACE inhibitors and antidiabetic agents may cause a pronounced hypoglycaemic effect with the risk of hypoglycaemia.

 

Benazepril, lithium

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.

 

Benazepril, narcotics

Increased hypotensive effect.

 

Benazepril, oral antidiabetics

Concomitant treatment with ACE inhibitors and antidiabetic agents may cause a pronounced hypoglycaemic effect with the risk of hypoglycaemia.

 

Benazepril, potassium

Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.

 

Benazepril, potassium-sparing diuretics

Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.

 

Benazepril, pregnancy

The use of ACE inhibitors is not recommended during the first trimester of pregnancy. The use of ACE inhibitors is contra-indicated during the 2nd and 3rd trimester of pregnancy

 

Benazepril, probenecide

A pre-treatment with probenecid may increase the pharmacodynamic response to ACE inhibitors. Dose adjustment may be necessary

 

Benazepril, procainamide

Increased blood count alterations

 

Benazepril, sodium

Decreased hypotensive effect

 

Benazepril, spironolactone

Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.

 

Benazepril, sympathomimetics ---> SPC of [lisinopril] of eMC

Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.

 

Benazepril, table salt

Decreased hypotensive effect

 

Benazepril, triamterene

Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.


 

Bendamustine

 

CYP1A2 inhibitors, bendamustine [2] ---> SPC of [2] of eMC

Bendamustine metabolism involves cytochrome P450 (CYP) 1A2 isoenzyme. Therefore, the potential for interaction with CYP1A2 inhibitors

 

Ability to drive, bendamustine [2] ---> SPC of [2] of eMC

Ataxia, peripheral neuropathy and somnolence have been reported during treatment with bendamustine

 

Aciclovir, bendamustine [2] ---> SPC of [2] of eMC

Bendamustine metabolism involves cytochrome P450 (CYP) 1A2 isoenzyme. Therefore, the potential for interaction with CYP1A2 inhibitors

 

Bendamustine [1], breast-feeding ---> SPC of [1] of eMC

Breast feeding must be discontinued during treatment with bendamustine

 

Bendamustine [1], cimetidine ---> SPC of [1] of eMC

Bendamustine metabolism involves cytochrome P450 (CYP) 1A2 isoenzyme. Therefore, the potential for interaction with CYP1A2 inhibitors

 

Bendamustine [1], ciprofloxacin ---> SPC of [1] of eMC

Bendamustine metabolism involves cytochrome P450 (CYP) 1A2 isoenzyme. Therefore, the potential for interaction with CYP1A2 inhibitors

 

Bendamustine [1], cyclosporine ---> SPC of [1] of eMC

Combination of bendamustine with cyclosporine may result in excessive immunosuppression with risk of lymphoproliferation.

 

Bendamustine [1], fluvoxamine ---> SPC of [1] of eMC

Bendamustine metabolism involves cytochrome P450 (CYP) 1A2 isoenzyme. Therefore, the potential for interaction with CYP1A2 inhibitors

 

Bendamustine [1], myelosuppressive agents ---> SPC of [1] of eMC

When bendamustine is combined with myelosuppressive agents, the effect of bendamustine and/or the co-administered medicinal products on the bone marrow may be potentiated

 

Bendamustine, obinutuzumab [2] ---> SPC of [2] of EMA

The combination of obinutuzumab with chlorambucil or bendamustine may increase neutropenia

 

Bendamustine [1], pregnancy ---> SPC of [1] of eMC

During pregnancy bendamustine should not be used unless clearly necessary

 

Bendamustine, rolapitant [2] ---> SPC of [2] of EMA

Rolapitant is an inhibitor of Breast-Cancer-Resistance Protein (BCRP). Increased plasma concentrations of BCRP substrates may result in potential adverse reactions.

 

Bendamustine [1], strong CYP1A2 inhibitors ---> SPC of [1] of eMC

Bendamustine metabolism involves cytochrome P450 (CYP) 1A2 isoenzyme. Therefore, the potential for interaction with CYP1A2 inhibitors

 

Bendamustine [1], tacrolimus ---> SPC of [1] of eMC

Combination of bendamustine with tacrolimus may result in excessive immunosuppression with risk of lymphoproliferation.

 

Bendamustine [1], vaccinations with live organism vaccines ---> SPC of [1] of eMC

Cytostatics can reduce antibody formation following live-virus vaccination and increase the risk of infection which may lead to fatal outcome.

 

Bendamustine [1], yellow fever vaccine ---> SPC of [1] of eMC

Cytostatics can reduce antibody formation following live-virus vaccination and increase the risk of infection which may lead to fatal outcome. The vaccine is contraindicated

 

 

           CONTRAINDICATIONS of Bendamustine

            

           - Hypersensitivity to the active substance or to any of the excipients

           - During breast feeding

           - Severe hepatic impairment (serum bilirubin> 3.0 mg/dl)

           - Jaundice

           - Severe bone marrow suppression and severe blood count alterations (leukocyte and/or platelet values dropped to < 3,000/µl or < 75,000/µl, respectively)

           - Major surgery less than 30 days before start of treatment

           - Infections, especially involving leukocytopenia

           - Yellow fever vaccination

            

           http://www.medicines.org.uk/emc/


 




Benralizumab (Fasenra)

Benralizumab [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from using Fasenra taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Benralizumab [1], CYP450 enzymes ---> SmPC of [1] of EMA

Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of benralizumab.

 

Benralizumab [1], eosinophils ---> SmPC of [1] of EMA

Eosinophil depletion does not produce chronic systemic alterations of proinflammatory cytokines.

 

Benralizumab [1], fertility ---> SmPC of [1] of EMA

There are no fertility data in humans. Animal studies showed no adverse effects of benralizumab treatment on fertility (see section 5.3).

 

Benralizumab [1], pharmacokinetics ---> SmPC of [1] of EMA

An effect of benralizumab on the pharmacokinetics of co-administered medicinal products is not expected (see section 5.2).

 

Benralizumab [1], pregnancy ---> SmPC of [1] of EMA

It is preferable to avoid the use of Fasenra during pregnancy. Its administration to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.

 

 

             CONTRAINDICATIONS of Benralizumab (Fasenra)        

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

              

             https://www.ema.europa.eu/en/documents/product-information/fasenra-epar-product-information_en.pdf  14/02/2025 



          

Benzbromarone

 

Acetylsalicylic acid, benzbromarone ---> SPC of [clopidogrel/acetylsalicylic acid] of EMA

Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.

 

Allopurinol, benzbromarone

Decreased allopurinol effect

 

Antituberculous therapy, benzbromarone

The co-administration of benzbromarone with hepatotoxic drugs is contraindicated

 

Benzbromarone, breast-feeding

Benzbromarone should not be used during breastfeeding

 

Benzbromarone, clopidogrel/acetylsalicylic acid [2] ---> SPC of [2] of EMA

Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.

 

Benzbromarone, hepatotoxic drugs

The co-administration of benzbromarone with hepatotoxic drugs is contraindicated

 

Benzbromarone, pregnancy

The administration of benzbromarone during pregnancy is contraindicated

 

Benzbromarone, pyrazinamide

Pyrazinamide can decrease the effect of benzbromarone. Concomitant use of benzbromarone and pyrazinamide increases the risk of hepatotoxic adverse effects

 

Benzbromarone, salicylates

Decreased uricosuric effect

 

Benzbromarone, sulfinpyrazone

Decreased uricosuric effect

 

Benzbromarone, vitamin K antagonists

The co-administration may enhance the effect of anticoagulant

 

Benzbromarone, warfarin

Benzbromarone may enhance the effect and/or toxicity of warfarin


 

Benzocaine

 

Anticholinesterase, benzocaine

Cholinesterase inhibitors inhibit benzocaine metabolism

 

Benzocaine [1], breast-feeding ---> SPC of [1] of eMC

No clinical data are available on the use of this product during lactation

 

Benzocaine, glibenclamide

The co-administration may weaken the hypoglycemic effect

 

Benzocaine, hyaluronidase

Hyaluronidase increases the incidence of systemic reaction of benzocaine

 

Benzocaine, lidocaine/prilocaine [2] ---> SPC of [2] of EMA

Methaemoglobinaemia may be accentuated in patients already taking medicinal products known to induce the condition

 

Benzocaine [1], pregnancy ---> SPC of [1] of eMC

No clinical data are available on the use of this product during pregnancy

 

Benzocaine [1], sulphamides ---> SPC of [1] of eMC

Benzocaine, like other derivatives of para-aminobenzoic acid, inhibits the actions of sulphonamides and therefore should not be used concomitantly with any sulphonamide.

 

Benzocaine [1], sulphonamides ---> SPC of [1] of eMC

Benzocaine, like other derivatives of para-aminobenzoic acid, inhibits the actions of sulphonamides and therefore should not be used concomitantly with any sulphonamide.

 

 

           CONTRAINDICATIONS of Benzocaine

            

           - Known sensitivity to benzocaine or any of the other ingredients.

           - Not to be used in those individuals suspected of lacking the normal ability to convert methaemoglobin to haemoglobin,

           - Not for use in children below the age of 12 years.

            

           http://www.medicines.org.uk/emc/


 

 

Benzoyl peroxide

 

Benzoyl peroxide [1], breast-feeding ---> SPC of [1] of eMC

Topical benzoyl peroxide should be used during lactation only if the expected benefit justifies the potential risk. If used during lactation, it should not be applied to the breast area to avoid accidental ingestion by the infant.

 

Benzoyl peroxide [1], pregnancy ---> SPC of [1] of eMC

Benzoyl peroxide should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.

 

 

           CONTRAINDICATIONS of Benzoyl peroxide

            

           - Patients with a known hypersensitivity to any of the ingredients should not use the product.

            

           http://www.medicines.org.uk/emc/


 

 

 

Beremagene geperpavec (Vyjuvek)

Beremagene geperpavec [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Vyjuvek therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

 

Beremagene geperpavec [1], fertility ---> SmPC of [1] of EMA

No nonclinical or clinical studies have been performed to evaluate the effect of beremagene geperpavec on fertility.

 

Beremagene geperpavec [1], medicinal products ---> SmPC of [1] of EMA

No interaction studies have been conducted with Vyjuvek. Interactions with topical medicinal products have not been investigated in clinical trials. Other topical medicinal products should not be concomitantly administered with Vyjuvek.

 

Beremagene geperpavec [1], pregnancy ---> SmPC of [1] of EMA

Pregnant women should not handle dressing waste. Carers or HCPs applying the gel should comply with the requirement to cover wounds with dressings.

 

Beremagene geperpavec [1], pregnancy ---> SmPC of [1] of EMA

There are no data from the use of beremagene geperpavec in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). The use of Vyjuvek is not recommended during pregnancy.

 

Beremagene geperpavec [1], squamous cell carcinoma ---> SmPC of [1] of EMA

Vyjuvek should not be applied to wounds with a confirmed or suspicious diagnosis of squamous cell carcinoma (SCC). Vyjuvek may still be applied to other wounds in patients who develop SCC.

 

Beremagene geperpavec [1], sterility ---> SmPC of [1] of EMA

Although beremagene geperpavec is tested for sterility, a risk of transmission of infectious agents exists.

 

Beremagene geperpavec [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

There is no data to suggest that Vyjuvek may interfere with the body's ability to appropriately respond to a live virus vaccines.

 

 

 

            CONTRAINDICATIONS of Beremagene geperpavec (Vyjuvek)      

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

            https://www.ema.europa.eu/en/documents/product-information/vyjuvek-epar-product-information_en.pdf 06/05/2025             

 




Berotralstat (Orladeyo)

BCRP inductors, berotralstat [2] ---> SmPC of [2] of EMA

P-gp and BCRP inducers (e.g. rifampicin, St. John's wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of berotralstat. The use of P-gp inducers is not recommended with berotralstat.

 

Berotralstat [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Orladeyo therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Berotralstat [1], contraceptives ---> SmPC of [1] of EMA

As a moderate inhibitor of CYP3A4, berotralstat may increase concentrations of oral contraceptives metabolised by CYP3A4.

 

Berotralstat [1], cyclosporine ---> SmPC of [1] of EMA

Refer to the SmPC for concomitant medicines that are predominantly metabolised by CYP3A4, particularly those with a narrow therapeutic index (e.g. cyclosporine, fentanyl). Dose adjustments of these medicines may be required

 

Berotralstat [1], dabigatran ---> SmPC of [1] of EMA

Refer to the SmPC for concomitants that are P-gp substrates, particularly with a narrow therapeutic index (e.g. digoxin) or whose prescribing information recommends therapeutic monitoring. Dose adjustments of these medicines may be required

 

Berotralstat [1], desipramine ---> SmPC of [1] of EMA

Berotralstat is a moderate inhibitor of CYP2D6, increasing the Cmax and AUC of dextromethorphan by 196% and 177%, respectively, and the Cmax and AUC of desipramine by 64% and 87%, respectively.

 

Berotralstat [1], desogestrel ---> SmPC of [1] of EMA

The effect of berotralstat on the CYP2C9 conversion of desogestrel to etonogestrel (active metabolite) was negligible. No dose adjustment is recommended for concomitant use of desogestrel.

 

Berotralstat [1], dextromethorphan ---> SmPC of [1] of EMA

Berotralstat is a moderate inhibitor of CYP2D6, increasing the Cmax and AUC of dextromethorphan by 196% and 177%, respectively, and the Cmax and AUC of desipramine by 64% and 87%, respectively.

 

Berotralstat [1], digoxin ---> SmPC of [1] of EMA

Refer to the SmPC for concomitants that are P-gp substrates, particularly with a narrow therapeutic index (e.g. digoxin) or whose prescribing information recommends therapeutic monitoring. Dose adjustments of these medicines may be required

 

Berotralstat [1], drugs primarily metabolised by CYP2C19 ---> SmPC of [1] of EMA

No dose adjustment is recommended for concomitant use of medicines that are predominantly metabolised by CYP2C19 (e.g. omeprazole) (see section 5.2).

 

Berotralstat [1], drugs primarily metabolised by CYP2C9 ---> SmPC of [1] of EMA

No dose adjustment is recommended for concomitant use of medicines that are predominantly metabolised by CYP2C9 (e.g. tolbutamide) (see section 5.2).

 

Berotralstat [1], drugs primarily metabolised by CYP2D6 ---> SmPC of [1] of EMA

Concomitant administration may increase exposure of other medicines that are CYP2D6 substrates.

 

Berotralstat [1], drugs primarily metabolised by CYP2D6 with narrow therapeutic index ---> SmPC of [1] of EMA

Refer to the SmPC for concomitants predominantly metabolised by CYP2D6, particularly with a narrow therapeutic index or whose prescribing information recommends therapeutic monitoring. Dose adjustments of these medicines may be required

 

Berotralstat [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA

Concomitant administration may increase concentrations of other medicines that are CYP3A4 substrates.

 

Berotralstat [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of EMA

Refer to the SmPC for concomitant medicines that are predominantly metabolised by CYP3A4, particularly those with a narrow therapeutic index (e.g. cyclosporine, fentanyl). Dose adjustments of these medicines may be required

 

Berotralstat [1], electrolyte disturbances ---> SmPC of [1] of EMA

The concomitant use of other medicinal products known to prolong the QT. It is preferable to avoid the use of berotralstat in these patients. If treatment is required, appropriate monitoring (e.g. ECGs) should be considered.

 

Berotralstat [1], fentanyl ---> SmPC of [1] of EMA

Refer to the SmPC for concomitant medicines that are predominantly metabolised by CYP3A4, particularly those with a narrow therapeutic index (e.g. cyclosporine, fentanyl). Dose adjustments of these medicines may be required

 

Berotralstat [1], fertility ---> SmPC of [1] of EMA

No effect on fertility was observed in animal studies (see section 5.3).

 

Berotralstat [1], foods ---> SmPC of [1] of EMA

Berotralstat is to be administered with food to minimise gastrointestinal adverse events.

 

Berotralstat [1], inhibition of P-gp and BCRP ---> SmPC of [1] of EMA

No dose adjustment of berotralstat is recommended for concomitant use with P-gp and BCRP inhibitors.

 

Berotralstat [1], liver insufficiency ---> SmPC of [1] of EMA

Patients with moderate or severe hepatic impairment may develop increased serum berotralstat concentrations that are associated with a risk of prolonged QT. Use of berotralstat in these patients should be avoided.

 

Berotralstat [1], midazolam ---> SmPC of [1] of EMA

Berotralstat is a moderate inhibitor of CYP3A4, increasing the Cmax and AUC of oral midazolam by 45% and 124%, respectively, and the Cmax and AUC of amlodipine by 45% and 77%, respectively.

 

Berotralstat [1], omeprazole ---> SmPC of [1] of EMA

No dose adjustment is recommended for concomitant use of medicines that are predominantly metabolised by CYP2C19 (e.g. omeprazole) (see section 5.2).

 

Berotralstat [1], P-glycoprotein substrates ---> SmPC of [1] of EMA

Refer to the SmPC for concomitants that are P-gp substrates, particularly with a narrow therapeutic index (e.g. digoxin) or whose prescribing information recommends therapeutic monitoring. Dose adjustments of these medicines may be required

 

Berotralstat [1], P-glycoprotein substrates with small therapeutic index ---> SmPC of [1] of EMA

Refer to the SmPC for concomitants that are P-gp substrates, particularly with a narrow therapeutic index (e.g. digoxin) or whose prescribing information recommends therapeutic monitoring. Dose adjustments of these medicines may be required

 

Berotralstat [1], P-gp inductors ---> SmPC of [1] of EMA

P-gp and BCRP inducers (e.g. rifampicin, St. John's wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of berotralstat. The use of P-gp inducers is not recommended with berotralstat.

 

Berotralstat [1], pimozide ---> SmPC of [1] of EMA

Refer to the SmPC for concomitants predominantly metabolised by CYP2D6, particularly with a narrow therapeutic index or whose prescribing information recommends therapeutic monitoring. Dose adjustments of these medicines may be required

 

Berotralstat [1], pregnancy ---> SmPC of [1] of EMA

Berotralstat is not recommended during pregnancy.

 

Berotralstat [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

An increase in QT prolongation may be observed with higher concentrations of berotralstat (see section 5.1).

 

Berotralstat [1], renal insufficiency ---> SmPC of [1] of EMA

Patients with severe renal impairment may be at risk of prolonged QT. It is preferable to avoid the use of berotralstat in these patients. If treatment is required, appropriate monitoring (e.g. ECGs) should be considered.

 

Berotralstat [1], rifampicin ---> SmPC of [1] of EMA

P-gp and BCRP inducers (e.g. rifampicin, St. John's wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of berotralstat. The use of P-gp inducers is not recommended with berotralstat.

 

Berotralstat [1], St. John's wort ---> SmPC of [1] of EMA

P-gp and BCRP inducers (e.g. rifampicin, St. John's wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of berotralstat. The use of P-gp inducers is not recommended with berotralstat.

 

Berotralstat [1], thioridazine ---> SmPC of [1] of EMA

Refer to the SmPC for concomitants predominantly metabolised by CYP2D6, particularly with a narrow therapeutic index or whose prescribing information recommends therapeutic monitoring. Dose adjustments of these medicines may be required

 

Berotralstat [1], tolbutamide ---> SmPC of [1] of EMA

No dose adjustment is recommended for concomitant use of medicines that are predominantly metabolised by CYP2C9 (e.g. tolbutamide) (see section 5.2).

 

Berotralstat [1], tricyclic antidepressant ---> SmPC of [1] of EMA

Refer to the SmPC for concomitants predominantly metabolised by CYP2D6, particularly with a narrow therapeutic index or whose prescribing information recommends therapeutic monitoring. Dose adjustments of these medicines may be required

 

Berotralstat [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential must use effective contraception during treatment with berotralstat and for at least 1 month following the last dose. Berotralstat is not recommended in women of childbearing potential not using contraception.

 

 

 

            CONTRAINDICATIONS of Berotralstat (Orladeyo)            

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

            https://www.ema.europa.eu/en/documents/product-information/orladeyo-epar-product-information_en.pdf 23/09/2024             

 





Besilesomab (Scintimun)

Antibiotics, besilesomab [2] ---> SmPC of [2] of EMA

Active substances which inhibit inflammation or affect the haematopoietic system (such as antibiotics and corticosteroids) may lead to false negative results.

 

Besilesomab [1], breast-feeding ---> SmPC of [1] of EMA

If the administration is considered necessary, breast-feeding should be interrupted for 3 days and the expressed milk discarded.

 

Besilesomab [1], breast-feeding ---> SmPC of [1] of EMA

Close contact with infants should be restricted during the first 12 hours after the injection.

 

Besilesomab [1], corticosteroids ---> SmPC of [1] of EMA

Active substances which inhibit inflammation or affect the haematopoietic system (such as antibiotics and corticosteroids) may lead to false negative results.

 

Besilesomab [1], pregnancy ---> SmPC of [1] of EMA

The use of besilesomab is contraindicated in pregnant women (see section 4.3).

 

Besilesomab [1], women of childbearing potential ---> SmPC of [1] of EMA

When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise.

 

 

             CONTRAINDICATIONS of Besilesomab (Scintimun)

             - Hypersensitivity to the active substance, to other murine antibodies, to any of the excipients listed in section 6.1or to any of the components of the labelled radiopharmaceutical.

             - Positive screening test for human anti-mouse antibody (HAMA).     

             - Pregnancy    

                          

             https://www.ema.europa.eu/en/documents/product-information/scintimun-epar-product-information_en.pdf 04/12/2024

    

 




          

Betahistine

 

IMAOs, betahistine

Caution is recommended when using betahistine and MAO inhibitors concomitantly.

 

Antihistamines, betahistine [2] ---> SPC of [2] of eMC

Betahistine is a histamine analogue, concurrent administration of H1 antagonists may cause a mutual attenuation of effect of the active agents.

 

Betahistine [1], breast-feeding ---> SPC of [1] of eMC

Betahistine should not be used during breastfeeding.

 

Betahistine, foods

Take this medication with food

 

Betahistine, hydroxyzine [2] ---> SPC of [2] of eMC

Hydroxyzine may antagonise the effects of betahistine

 

Betahistine [1], pregnancy ---> SPC of [1] of eMC

As a precautionary measure, it is preferable to avoid the use of betahistine during pregnancy.

 

 

           CONTRAINDICATIONS of Betahistine

            

           - Betahistine is encountered in patients on betahistine.

           - Patients with bronchial asthma should be monitored carefully during the treatment with betahistine.

           - Caution is advised in prescribing betahistine to patients with either urticaria, rashes or allergic rhinitis, because of the possibility of aggravating these symptoms.

           - Caution is advised in patients with severe hypotension.

           - Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

            

           http://www.medicines.org.uk/emc/


 



Betaine anhydrous (Cystadane)

GABA analogues, betaine anhydrous [2] ---> SPC of [2] of EMA

To minimise the risk of potential drug interactions, it is advisable to leave 30 minutes between the intake of betaine anhydrous and amino acids mixtures and/or medicinal products containing vigabatrin and GABA analogues

 

Amino acids, betaine anhydrous [2] ---> SPC of [2] of EMA

To minimise the risk of potential drug interactions, it is advisable to leave 30 minutes between the intake of betaine anhydrous and amino acids mixtures and/or medicinal products containing vigabatrin and GABA analogues

 

Betaine anhydrous [1], breast-feeding ---> SPC of [1] of EMA

Because of lack of data, caution should be exercised when prescribing Cystadane to breast-feeding women.

 

Betaine anhydrous [1], pregnancy ---> SPC of [1] of EMA

Cystadane should not be used during pregnancy unless clearly necessary

 

Betaine anhydrous [1], vigabatrin ---> SPC of [1] of EMA

To minimise the risk of potential drug interactions, it is advisable to leave 30 minutes between the intake of betaine anhydrous and amino acids mixtures and/or medicinal products containing vigabatrin and GABA analogues

 

 

             CONTRAINDICATIONS of Betaine anhydrous (Cystadane)       

             - Hypersensitivity to active substance

              

https://www.ema.europa.eu/en/documents/product-information/cystadane-epar-product-information_en.pdf 12/12/2024 


            


          

Betamethasone

 

Atazanavir/cobicistat [1], betamethasone ---> SPC of [1] of EMA

Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.

 

Atosiban [1], betamethasone ---> SPC of [1] of EMA

Interaction studies have been performed with labetalol and betamethasone in healthy, female volunteers. No clinically relevant interaction was found between atosiban and betamethasone or labetalol.

 

Betamethasone [1], breast-feeding ---> SPC of [1] of eMC

A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

 

Betamethasone, cobicistat [2] ---> SPC of [2] of EMA

Corticosteroids primarily metabolised by CYP3A. Plasma concentrations of these medicinal products may be increased when co-administered with cobicistat, resulting in reduced serum cortisol concentrations.

 

Betamethasone, darunavir/cobicistat [2] ---> SPC of [2] of EMA

Concomitant use of REZOLSTA and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.

 

Betamethasone, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA

Concomitant use of Genvoya and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.

 

Betamethasone, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA

Concomitant use of Stribild and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.

 

Betamethasone [1], pregnancy ---> SPC of [1] of eMC

The administration of betamethasone valerate during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus.

 

 

           CONTRAINDICATIONS of Betamethasone

            

           Hypersensitivity to the active substance or any of the excipients in the excipients

           The following conditions should not be treated with betamethasone valerate:

           - Untreated cutaneous infections

             - Rosacea

             - Acne vulgaris

             - Pruritus without inflammation

             - Perianal and genital pruritus

             - Perioral dermatitis

           Betamethasone valerate is contraindicated in dermatoses in infants under one year of age, including dermatitis

            

           http://www.medicines.org.uk/emc/


 


Bevacizumab (Avastin)

Ability to drive, bevacizumab [2] ---> SmPC of [2] of EMA

If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive and use machines until symptoms abate.

 

Anti-EGFR antibodies, bevacizumab [2] ---> SmPC of [2] of EMA

EGFR monoclonal antibodies should not be administered for the treatment of mCRC in combination with bevacizumab-containing chemotherapy.

 

Antineoplastics, bevacizumab [2] ---> SmPC of [2] of EMA

No clinically relevant pharmacokinetic interaction of co-administered chemotherapy on Avastin pharmacokinetics has been observed based on the results of a population PK analysis.

 

Bevacizumab [1], breast-feeding ---> SmPC of [1] of EMA

Women must discontinue breast-feeding during therapy and not breast-feed for at least 6 months following the last dose of Avastin.

 

Bevacizumab [1], capecitabine ---> SmPC of [1] of EMA

Results from one trial in metastatic colorectal cancer patients demonstrated no significant effect of bevacizumab on the pharmacokinetics of capecitabine and its metabolites

 

Bevacizumab [1], chemotherapy ---> SmPC of [1] of EMA

No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population pharmacokinetic analyses.

 

Bevacizumab [1], cisplatin ---> SmPC of [1] of EMA

Trial results demonstrated no significant effect of bevacizumab on the pharmacokinetics of cisplatin.

 

Bevacizumab [1], fertility ---> SmPC of [1] of EMA

There are no clinical trial data on the use of Avastin in pregnant women. Studies in animals have shown reproductive toxicity including malformations (see section 5.3). Long term effects of the treatment with bevacizumab on fertility are unknown.

 

Bevacizumab [1], gemcitabine ---> SmPC of [1] of EMA

Conclusions on the impact of bevacizumab on gemcitabine pharmacokinetics cannot be drawn.

 

Bevacizumab [1], interferon alfa-2a ---> SmPC of [1] of EMA

Results from one trial in renal cancer patients demonstrated no significant effect of bevacizumab on the pharmacokinetics of interferon alfa-2a.

 

Bevacizumab [1], irinotecan ---> SmPC of [1] of EMA

Results from a dedicated drug-drug interaction trial demonstrated no significant effect of bevacizumab on the pharmacokinetics of irinotecan and its active metabolite SN38.

 

Bevacizumab [1], pharmacokinetics ---> SmPC of [1] of EMA

No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of coadministered interferon alpha 2a, erlotinib, or the chemotherapies irinotecan, capecitabine, oxaliplatin, and cisplatin.

 

Bevacizumab [1], platinum compounds ---> SmPC of [1] of EMA

Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed mainly in patients treated with platinum-or taxane-based therapies

 

Bevacizumab [1], pregnancy ---> SmPC of [1] of EMA

Avastin is contraindicated in pregnancy

 

Bevacizumab [1], radiotherapy ---> SmPC of [1] of EMA

The safety and efficacy of concomitant administration of radiotherapy and Avastin has not been established.

 

Bevacizumab [1], sunitinib ---> SmPC of [1] of EMA

In two clinical trials of metastatic renal cell carcinoma, microangiopathic haemolytic anaemia (MAHA) was reported in 7 of 19 patients treated with bevacizumab and sunitinib malate combination.

 

Bevacizumab [1], taxanes ---> SmPC of [1] of EMA

Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed mainly in patients treated with platinum-or taxane-based therapies

 

Bevacizumab [1], VEGF inhibitors ---> SmPC of [1] of EMA

Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors.

 

Bevacizumab [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.

 

 

             CONTRAINDICATIONS of Bevacizumab (Avastin)          

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.

             - Pregnancy

              

             https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf 25/04/2025 

 

Other trade names:

Abevmy, Alymsys, Avzivi, Aybintio, Equidacent, Lytenava, Mvasi, Onbevzi, Oyavas, Vegzelma, Zirabev, 



Bexarotene (Targretin)

Ability to drive, bexarotene [2] ---> SmPC of [2] of EMA

Patients who experience dizziness or visual difficulties during therapy must not drive or operate machinery.

 

Atorvastatin, bexarotene [2] ---> SmPC of [2] of EMA

Under similar conditions, bexarotene concentrations were not affected by concomitant administration of atorvastatin or levothyroxine.

 

Bexarotene [1], breast-feeding ---> SmPC of [1] of EMA

Bexarotene should not be used in breast-feeding mothers.

 

Bexarotene [1], clarithromycin ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates may theoretically lead to an increase in plasma bexarotene concentrations.

 

Bexarotene [1], cyclophosphamide ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], cyclosporine ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4 substrates having a narrow therapeutic margin

 

Bexarotene [1], CYP3A4-metabolised cytotoxics ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], dexamethasone ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4). Co-administration with CYP3A4 inducers may theoretically cause a reduction in plasma bexarotene concentrations.

 

Bexarotene [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates may theoretically lead to an increase in plasma bexarotene concentrations.

 

Bexarotene [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4 substrates having a narrow therapeutic margin

 

Bexarotene [1], erythromycin ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates may theoretically lead to an increase in plasma bexarotene concentrations.

 

Bexarotene [1], etoposide ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], fertility ---> SmPC of [1] of EMA

There are no human data on the effect of bexarotene on fertility. In male dogs, some effects have been documented (see section 5.3). Effects on fertility cannot be excluded.

 

Bexarotene [1], finasteride ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], foods ---> SmPC of [1] of EMA

Because safety and efficacy data from clinical trials are based upon administration with food, it is recommended that Targretin capsules be administered with food.

 

Bexarotene [1], gemfibrozil ---> SmPC of [1] of EMA

A population analysis of plasma bexarotene concentrations in patients with CTCL indicated that concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene.

 

Bexarotene [1], grapefruit juice ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4, grapefruit juice may theoretically lead to an increase in plasma bexarotene concentrations.

 

Bexarotene [1], ifosfamide ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], insulin ---> SmPC of [1] of EMA

Bexarotene may potentially enhance the action of insulin, agents enhancing insulin secretion (e.g. sulfonylureas), or insulin-sensitisers (e.g. thiazolidinediones), resulting in hypoglycaemia (see section 4.4).

 

Bexarotene [1], itraconazol ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates may theoretically lead to an increase in plasma bexarotene concentrations.

 

Bexarotene [1], ketoconazole ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates may theoretically lead to an increase in plasma bexarotene concentrations.

 

Bexarotene [1], levothyroxine ---> SmPC of [1] of EMA

Under similar conditions, bexarotene concentrations were not affected by concomitant administration of atorvastatin or levothyroxine.

 

Bexarotene [1], men ---> SmPC of [1] of EMA

Male patients with sexual partners who are pregnant, possibly pregnant, or may potentially become pregnant must use condoms during sexual intercourse while taking bexarotene and for at least one month after the last dose.

 

Bexarotene [1], oral contraceptives ---> SmPC of [1] of EMA

Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestive contraceptives.

 

Bexarotene [1], ovarian cancer ---> SmPC of [1] of EMA

CA125 assay values in patients with ovarian cancer may be accentuated with bexarotene therapy.

 

Bexarotene [1], pancreatitis ---> SmPC of [1] of EMA

Patients with CTCL having risk factors for pancreatitis (e.g., medications known to be associated with pancreatic toxicity) should not be treated with bexarotene, unless the potential benefit outweighs the risk.

 

Bexarotene [1], phenobarbital ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4). Co-administration with CYP3A4 inducers may theoretically cause a reduction in plasma bexarotene concentrations.

 

Bexarotene [1], phenytoin ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4). Co-administration with CYP3A4 inducers may theoretically cause a reduction in plasma bexarotene concentrations.

 

Bexarotene [1], pregnancy ---> SmPC of [1] of EMA

Bexarotene is contraindicated in pregnancy

 

Bexarotene [1], pregnancy ---> SmPC of [1] of EMA

If this medicinal product is used inadvertently during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be informed of the potential hazard to the foetus.

 

Bexarotene [1], protease inhibitors ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates may theoretically lead to an increase in plasma bexarotene concentrations.

 

Bexarotene [1], retinol ---> SmPC of [1] of EMA

Because of the relationship of bexarotene to vitamin A, patients should be advised to limit vitamin A supplements to ≤15,000 IU/day to avoid potential additive toxic effects.

 

Bexarotene [1], rifampicin ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4). Co-administration with CYP3A4 inducers may theoretically cause a reduction in plasma bexarotene concentrations.

 

Bexarotene [1], sirolimus ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4 substrates having a narrow therapeutic margin

 

Bexarotene [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

On the basis of the oxidative metabolism of bexarotene by cytochrome P450 3A4 (CYP3A4). Co-administration with CYP3A4 inducers may theoretically cause a reduction in plasma bexarotene concentrations.

 

Bexarotene [1], sulfonylureas ---> SmPC of [1] of EMA

Bexarotene may potentially enhance the action of insulin, agents enhancing insulin secretion (e.g. sulfonylureas), or insulin-sensitisers (e.g. thiazolidinediones), resulting in hypoglycaemia (see section 4.4).

 

Bexarotene [1], sun ---> SmPC of [1] of EMA

Patients should be advised to minimise exposure to sunlight and avoid sun lamps during therapy with bexarotene, as in vitro data indicate that bexarotene may potentially have a photosensitising effect.

 

Bexarotene [1], tacrolimus ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4 substrates having a narrow therapeutic margin

 

Bexarotene [1], tamoxifen ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], thiazolidinedione ---> SmPC of [1] of EMA

Bexarotene may potentially enhance the action of insulin, agents enhancing insulin secretion (e.g. sulfonylureas), or insulin-sensitisers (e.g. thiazolidinediones), resulting in hypoglycaemia (see section 4.4).

 

Bexarotene [1], vinblastine ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], vinburnine ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], vinca alkaloids ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], vincamine ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], vincristine ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], vindesine ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], vinflunine ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], vinorelbine ---> SmPC of [1] of EMA

Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics

 

Bexarotene [1], vitamin A ---> SmPC of [1] of EMA

Because of the relationship of bexarotene to vitamin A, patients should be advised to limit vitamin A supplements to ≤15,000 IU/day to avoid potential additive toxic effects.

 

Bexarotene [1], women of childbearing potential ---> SmPC of [1] of EMA

Thus, if treatment with bexarotene is intended in a woman with childbearing potential, a reliable, non-hormonal contraceptive method is also recommended.

 

 

             CONTRAINDICATIONS of Bexarotene (Targretin)                     

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Pregnancy and lactation.       

             - Women of child-bearing potential without effective birth-control measures.             

             - History of pancreatitis.           

             - Uncontrolled hypercholesterolaemia.            

             - Uncontrolled hypertriglyceridaemia.  

             - Hypervitaminosis A.     

             - Uncontrolled thyroid disease.             

             - Hepatic insufficiency.              

             - Ongoing systemic infection.     

                          

             https://www.ema.europa.eu/en/documents/product-information/targretin-epar-product-information_en.pdf 12/05/2025 




          

Bezafibrate

 

CYP3A4 inhibitors, bezafibrate

The CYP3A4 inhibition may increase the plasma concentrations of bezafibrate

 

IMAOs, bezafibrate [2] ---> SPC of [2] of eMC

MAO-inhibitors (with hepatotoxic potential) should not be administered together with bezafibrate.

 

Antidiabetics, bezafibrate

The action of anti-diabetic medication might be potentiated

 

Bezafibrate [1], bile-acid sequestrants ---> SPC of [1] of eMC

Should combined therapy with an ion-exchange resin be considered necessary, there should be an interval of 2 hours between the intake of the resin and bezafibrate as the absorption of bezafibrate otherwise may be impaired.

 

Bezafibrate [1], breast-feeding ---> SPC of [1] of eMC

There is insufficient information on the excretion of bezafibrate or its metabolites in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from bezafibrate

 

Bezafibrate [1], cholestyramine ---> SPC of [1] of eMC

Should combined therapy with an ion-exchange resin be considered necessary, there should be an interval of 2 hours between the intake of the resin and bezafibrate as the absorption of bezafibrate otherwise may be impaired.

 

Bezafibrate, colchicine

Concomitant use of medicinal products that may cause rhabdomyolysis, in particular fibrates and statins, may increase the risk of rhabdomyolysis

 

Bezafibrate [1], coumarin anticoagulants ---> SPC of [1] of eMC

Care is required in administering bezafibrate to patients taking coumarin-type anti-coagulants, the action of which may be potentiated.

 

Bezafibrate, cyclosporine [2] ---> SPC of [2] of eMC

Care should be taken when using ciclosporin together with other active substances that exhibit nephrotoxic synergy

 

Bezafibrate [1], estrogens ---> SPC of [1] of eMC

Since oestrogens may lead to a rise in lipid levels, the prescribing of bezafibrate in patients taking oestrogens or oestrogen-containing contraceptives must be critically considered on an individual basis.

 

Bezafibrate, fluvastatin [2] ---> SPC of [2] of eMC

An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors together with bezafibrate

 

Bezafibrate, furosemide

Bezafibrate may enhance the furosemide effect due to displacement from its plasma protein binding

 

Bezafibrate, glibenclamide

The co-administration may enhance the hypoglycemic effect

 

Bezafibrate [1], immunosuppressives ---> SPC of [1] of eMC

In isolated cases, a pronounced though reversible impairment of renal function has been reported in organ transplant patients receiving immuno-suppressant therapy and concomitant bezafibrate.

 

Bezafibrate [1], insulin ---> SPC of [1] of eMC

As bezafibrate improves glucose utilization the action of antidiabetic medication, including insulin, may be potentiated. Hypoglycaemia has not been observed although increased monitoring of the glycaemic status may be warranted

 

Bezafibrate, perhexiline

Bezafibrate may enhance the adverse/toxic effect of perhexiline. Avoid concomitant use

 

Bezafibrate, phenytoin

Bezafibrate may enhance the phenytoin effect due to displacement from its plasma protein binding

 

Bezafibrate [1], pregnancy ---> SPC of [1] of eMC

There are limited data from the use of bezafibrate in pregnant women. It is not recommended during pregnancy and in women of childbearing potential not using contraception

 

Bezafibrate [1], statins ---> SPC of [1] of eMC

Interaction between statins and fibrates may vary in nature and intensity depending on the combination of the administered drugs. An interaction between these two classes of drugs may, in some cases, also contribute to an increase in the risk of myopathy

 

Bezafibrate, strong CYP3A4 inhibitors

The strong CYP3A4 inhibition may increase the plasma concentrations of bezafibrate

 

Bezafibrate [1], sulfonylureas ---> SPC of [1] of eMC

As bezafibrate improves glucose utilization the action of antidiabetic medication, including insulin, may be potentiated. Hypoglycaemia has not been observed although increased monitoring of the glycaemic status may be warranted

 

 

           CONTRAINDICATIONS of Bezafibrate

            

           - Significant hepatic disease (other than fatty infiltration of the liver associated with raised triglyceride values).

           - Gall-bladder diseases with or without cholelithiasis.

           - Patients with nephrotic syndrome and severe renal failure (serum creatinine > 530 µmol/l; creatinine clearance < 15 ml/min) and patients undergoing dialysis

           - Combination therapy of bezafibrate with HMG CoA reductase inhibitors in patients with predisposing factors for myopathy

           - Known hypersensitivity to bezafibrate, to any component of the product or to other fibrates.

           - Known photoallergic or phototoxic reactions to fibrates.

            

           http://www.medicines.org.uk/emc/


 

 


Bezlotoxumab (Zinplava)

Bezlotoxumab [1], breast-feeding ---> SmPC of [1] of EMA

A decision should be made whether to discontinue breastfeeding or to not administer ZINPLAVA, taking into account the importance of ZINPLAVA to the mother.

 

Bezlotoxumab [1], cytochrome P450 ---> SmPC of [1] of EMA

Therapeutic monoclonal antibodies do not typically have significant drug-drug interaction potential, as they do not directly affect cytochrome P450 enzymes and are not substrates of hepatic or renal transporters.

 

Bezlotoxumab [1], exogenous toxin ---> SmPC of [1] of EMA

Bezlotoxumab-mediated drug-drug interactions are unlikely as the target of bezlotoxumab is an exogenous toxin.

 

Bezlotoxumab [1], fertility ---> SmPC of [1] of EMA

There was no binding of bezlotoxumab to reproductive tissue in tissue cross-reactivity studies, and no notable effects in the male and female reproductive organs in repeat dose toxicity studies in mice (see section 5.3).

 

Bezlotoxumab [1], pregnancy ---> SmPC of [1] of EMA

ZINPLAVA should not be used during pregnancy unless the clinical condition of the woman requires treatment with bezlotoxumab.

 

 

             CONTRAINDICATIONS of Bezlotoxumab (Zinplava)     

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

                          

             https://www.ema.europa.eu/en/documents/product-information/zinplava-epar-product-information_en.pdf 01/03/2024      

                        


            

Bicalutamide

 

Ability to drive, bicalutamide [2] ---> SPC of [2] of eMC

It should be noted that occasionally dizziness or somnolence may occur

 

Astemizole, bicalutamide [2] ---> SPC of [2] of eMC

Bicalutamide, CYP3A4 inhibitor, may increase the plasma concentrations of astemizole. The co-administration is contraindicated.

 

Bicalutamide [1], breast-feeding ---> SPC of [1] of eMC

Not applicable, since this medicinal product is not used in women.

 

Bicalutamide [1], calcium antagonists ---> SPC of [1] of eMC

Caution should be used when administering bicalutamide (CYP3A4 inhibitor) with a calcium antagonist (metabolised by CYP3A4)

 

Bicalutamide [1], cimetidine ---> SPC of [1] of eMC

Caution should be exercised when administering bicalutamide to patients taking medicinal products that inhibit the oxidation processes in the liver

 

Bicalutamide [1], cisapride ---> SPC of [1] of eMC

Bicalutamide, CYP3A4 inhibitor, may increase the plasma concentrations of cisapride. The co-administration is contraindicated.

 

Bicalutamide [1], coumarin anticoagulants ---> SPC of [1] of eMC

Bicalutamide can displace the coumarin anticoagulant, warfarin, from its protein binding site. It is recommended that prothrombin time is closely monitored if bicalutamide is started in patients who are already receiving coumarin anticoagulants.

 

Bicalutamide [1], drugs primarily metabolised by CYP3A4 ---> SPC of [1] of eMC

Bicalutamide has been shown to inhibit cytochrome P450 (CYP 3A4), as such, caution should be exercised when co-administered with drugs metabolised predominantly by CYP 3A4

 

Bicalutamide [1], enzyme inhibitors ---> SPC of [1] of eMC

Caution should be exercised when administering bicalutamide to patients taking medicinal products that inhibit the oxidation processes in the liver

 

Bicalutamide [1], ketoconazole ---> SPC of [1] of eMC

Caution should be exercised when administering bicalutamide to patients taking medicinal products that inhibit the oxidation processes in the liver

 

Bicalutamide, lomitapide [2] ---> SPC of [2] of EMA

Weak CYP3A4 inhibitors are expected to increase the exposure of lomitapide when taken simultaneously. Separate the dose of the medications by 12 hours OR decrease the dose of Lojuxta by half.

 

Bicalutamide [1], midazolam ---> SPC of [1] of eMC

Mean midazolam exposure (AUC) was increased by up to 80 %, after coadministration of bicalutamide for 28 days.

 

Bicalutamide [1], pregnancy ---> SPC of [1] of eMC

Not applicable, since this medicinal product is not used in women.

 

Bicalutamide [1], terfenadine ---> SPC of [1] of eMC

Bicalutamide, CYP3A4 inhibitor, may increase the plasma concentrations of terfenadine. The co-administration is contraindicated.

 

Bicalutamide [1], warfarin ---> SPC of [1] of eMC

Bicalutamide can displace the coumarin anticoagulant, warfarin, from its protein binding site. It is recommended that prothrombin time is closely monitored if bicalutamide is started in patients who are already receiving coumarin anticoagulants.

 

 

           CONTRAINDICATIONS of Bicalutamide

            

           - Hypersensitivity to the active substance or to any of the excipients

           - Bicalutamide is contraindicated in women and children.

           - Co-administration of terfenadine, astemizole or cisapride with bicalutamide is contra-indicated

            

           http://www.medicines.org.uk/emc/


 



Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy)

Ability to drive, bictegravir/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Patients should be informed that dizziness has been reported during treatment with the components of Biktarvy

 

Antacids, bictegravir/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Chelation with polyvalent cations. Biktarvy should be administered at least 2 hours before, or with food 2 hours after antacids containing magnesium and/or aluminium.

 

Antiretrovirals, bictegravir/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Biktarvy should not be co-administered with other antiretroviral medicinal products.

 

Atazanavir, bictegravir/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration is not recommended.

 

Azithromycin, bictegravir/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Interaction not studied. Coadministration of azithromycin or clarithromycin may increase bictegravir plasma concentrations.

 

BCRP substrates, bictegravir/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir)

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], breast-feeding ---> SmPC of [1] of EMA

Biktarvy should not be used during breast-feeding. In order to avoid transmission of HIV to the infant it is recommended that women living with HIV do not breast-feed their infants.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], calcium carbonate ---> SmPC of [1] of EMA

Chelation with polyvalent cations. Biktarvy and calcium-containing supplements can be taken together, without regard to food.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], carbamazepine ---> SmPC of [1] of EMA

Co-administration is not recommended.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], clarithromycin ---> SmPC of [1] of EMA

Interaction not studied. Coadministration of azithromycin or clarithromycin may increase bictegravir plasma concentrations.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], cyclosporine ---> SmPC of [1] of EMA

Co-administration of ciclosporin (IV or oral use) is not recommended. If the combination is needed, clinical and biological monitoring, notably renal function, is recommended.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], dronedarone ---> SmPC of [1] of EMA

Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir)

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], ethinylestradiol/norgestimate ---> SmPC of [1] of EMA

No dose adjustment is required upon co-administration.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], ferrous fumarate ---> SmPC of [1] of EMA

Chelation with polyvalent cations. Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], fertility ---> SmPC of [1] of EMA

No human data on the effect of Biktarvy on fertility are available. Animal studies indicate no effects of bictegravir, emtricitabine or tenofovir alafenamide on mating or fertility (see section 5.3).

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], glecaprevir/pibrentasvir ---> SmPC of [1] of EMA

Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir)

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], iron ---> SmPC of [1] of EMA

Chelation with polyvalent cations. Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], itraconazol ---> SmPC of [1] of EMA

No dose adjustment is required upon co-administration.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], ledipasvir/sofosbuvir ---> SmPC of [1] of EMA

No dose adjustment is required upon co-administration.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], MATE1 substrates ---> SmPC of [1] of EMA

Biktarvy may be co-administered with substrates of OCT2 and MATE1.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], metformin ---> SmPC of [1] of EMA

In patients with moderate renal impairment, close monitoring should be considered when starting coadministration of bictegravir with metformin, due to the increased risk for lactic acidosis in these patients.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], methadone ---> SmPC of [1] of EMA

Caution is recommended.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], midazolam ---> SmPC of [1] of EMA

No dose adjustment is required upon co-administration.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], OCT2 substrates ---> SmPC of [1] of EMA

Biktarvy may be co-administered with substrates of OCT2 and MATE1.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], oxcarbazepine ---> SmPC of [1] of EMA

Co-administration is not recommended.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], P-glycoprotein substrates ---> SmPC of [1] of EMA

Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir)

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], phenobarbital ---> SmPC of [1] of EMA

Co-administration is not recommended.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], phenytoin ---> SmPC of [1] of EMA

Co-administration is not recommended.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], posaconazole ---> SmPC of [1] of EMA

No dose adjustment is required upon co-administration.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], pregnancy ---> SmPC of [1] of EMA

Biktarvy should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], rifabutin ---> SmPC of [1] of EMA

Co-administration is not recommended due to the expected decrease of tenofovir alafenamide.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], rifampicin ---> SmPC of [1] of EMA

Co-administration of rifampicin may decrease tenofovir alafenamide plasma concentrations. Co-administration is contraindicated due to the effect of rifampicin on the bictegravir component of Biktarvy.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], rifapentine ---> SmPC of [1] of EMA

Co-administration is not recommended.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], sertraline ---> SmPC of [1] of EMA

No dose adjustment is required upon co-administration.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], sofosbuvir/velpatasvir/voxilaprevir ---> SmPC of [1] of EMA

No dose adjustment is required upon co-administration.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], St. John's wort ---> SmPC of [1] of EMA

Co-administration may decrease bictegravir and tenofovir alafenamide plasma concentrations. Co-administration with St John's wort is contraindicated, due to the effect of St John's wort on the bictegravir component of Biktarvy.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], strong BCRP inhibitors ---> SmPC of [1] of EMA

Co-administration of Biktarvy with other medicinal products that inhibit P-gp and BCRP may increase the absorption and plasma concentration of tenofovir alafenamide.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

Co-administration of bictegravir and medicinal products that potently induce both CYP3A and UGT1A1 is contraindicated

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Co-administration of bictegravir with medicinal products that potently inhibit both CYP3A and UGT1A1, such as atazanavir, may significantly increase plasma concentrations of bictegravir, therefore co-administration is not recommended.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], strong P-gp inductors ---> SmPC of [1] of EMA

Medicinal products that induce P-gp are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma level of tenofovir alafenamide, which may lead to loss of therapeutic effect of Biktarvy and development of resistance.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], strong P-gp inhibitors ---> SmPC of [1] of EMA

Co-administration of Biktarvy with other medicinal products that inhibit P-gp and BCRP may increase the absorption and plasma concentration of tenofovir alafenamide.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], strong UGT1A1 inductors ---> SmPC of [1] of EMA

Co-administration of bictegravir and medicinal products that potently induce both CYP3A and UGT1A1 is contraindicated

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], strong UGT1A1 inhibitors ---> SmPC of [1] of EMA

Co-administration of bictegravir with medicinal products that potently inhibit both CYP3A and UGT1A1, such as atazanavir, may significantly increase plasma concentrations of bictegravir, therefore co-administration is not recommended.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], sucralfate ---> SmPC of [1] of EMA

Co-administration is not recommended.

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], verapamil ---> SmPC of [1] of EMA

Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir)

 

Bictegravir/emtricitabine/tenofovir alafenamide [1], voriconazole ---> SmPC of [1] of EMA

No dose adjustment is required upon co-administration.

 

Bictegravir/emtricitabine/tenofovir alafenamide, boceprevir ---> SmPC of [boceprevir] of EMA

Co-administration is not recommended.

 

 

 

            CONTRAINDICATIONS of Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy)      

            - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

            - Co-administration with rifampicin and St John’s Wort (Hypericum perforatum) (see section 4.5).    

 

            https://www.ema.europa.eu/en/documents/product-information/biktarvy-epar-product-information_en.pdf 23/07/2024             

 



          

Bifonazole

 

Bifonazole, breast-feeding

Should not be used during breast-feeding

 

Bifonazole, latex

Decreased functionality

 

Bifonazole, pregnancy

Strict indication


 

 

 

Bilastine

 

OATP1A2 substrates, bilastine [2] ---> SPC of [2] of eMC

Medicinal products that are substrates or inhibitors of OATP1A2 may likewise have the potential to decrease bioavailability of bilastine (OATP1A2 substrate).

 

OATP1B2 inhibitors, bilastine [2] ---> SPC of [2] of eMC

Medicinal products that are substrates or inhibitors of OATP1A2 may likewise have the potential to decrease bioavailability of bilastine (OATP1A2 substrate).

 

P-gp inhibitors, bilastine [2] ---> SPC of [2] of eMC

Concomitant intake of bilastine, substrate for P-gp, may likewise have the potential to increase plasma concentrations of bilastine.

 

Ability to drive, bilastine [2] ---> SPC of [2] of eMC

Patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

 

Bilastine [1], breast-feeding ---> SPC of [1] of eMC

A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy

 

Bilastine [1], cyclosporine ---> SPC of [1] of eMC

Concomitant intake of bilastine, substrate for P-gp, may likewise have the potential to increase plasma concentrations of bilastine.

 

Bilastine [1], diltiazem ---> SPC of [1] of eMC

Concomitant intake of bilastine, substrate for P-gp, may likewise have the potential to increase plasma concentrations of bilastine.

 

Bilastine [1], erythromycin ---> SPC of [1] of eMC

Concomitant intake of bilastine, substrate for P-gp, may likewise have the potential to increase plasma concentrations of bilastine.

 

Bilastine [1], foods ---> SPC of [1] of eMC

Food significantly reduces the oral bioavailability of bilastine by 30%.

 

Bilastine [1], grapefruit juice ---> SPC of [1] of eMC

Medicinal products that are substrates or inhibitors of OATP1A2 may likewise have the potential to decrease bioavailability of bilastine (OATP1A2 substrate).

 

Bilastine [1], ketoconazole ---> SPC of [1] of eMC

Concomitant intake of bilastine, substrate for P-gp, may likewise have the potential to increase plasma concentrations of bilastine.

 

Bilastine [1], pregnancy ---> SPC of [1] of eMC

As a precautionary measure, it is preferable to avoid the use of bilastine during pregnancy

 

Bilastine [1], rifampicin ---> SPC of [1] of eMC

Medicinal products that are substrates or inhibitors of OATP1A2 may likewise have the potential to decrease bioavailability of bilastine (OATP1A2 substrate).

 

Bilastine [1], ritonavir ---> SPC of [1] of eMC

Concomitant intake of bilastine, substrate for P-gp, may likewise have the potential to increase plasma concentrations of bilastine.

 

Bilastine [1], strong P-gp inhibitors ---> SPC of [1] of eMC

Concomitant intake of bilastine, substrate for P-gp, may likewise have the potential to increase plasma concentrations of bilastine.

 

 

           CONTRAINDICATIONS of Bilastine

            

           - Hypersensitivity to the active substance bilastine or to any of the excipients

            

           http://www.medicines.org.uk/emc/


 



Bimatoprost (Lumigan)

Ability to drive, bimatoprost [2] ---> SmPC of [2] of EMA

As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines.

 

Betablockers, bimatoprost [2] ---> SmPC of [2] of EMA

In clinical studies, bimatoprost 0.3 mg/ml, eye drops, solution was used concomitantly with a number of different ophthalmic beta-blocking agents without evidence of interactions.

 

Bimatoprost [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue from LUMIGAN therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

 

Bimatoprost [1], fertility ---> SmPC of [1] of EMA

There are no data on the effects of bimatoprost on human fertility.

 

Bimatoprost [1], interactions ---> SmPC of [1] of EMA

No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng/ml) following ocular dosing with bimatoprost 0.3 mg/ml eye drops, solution.

 

Bimatoprost [1], pregnancy ---> SmPC of [1] of EMA

Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3). LUMIGAN should not be used during pregnancy unless clearly necessary.

 

Bimatoprost [1], prostaglandin analogues ---> SmPC of [1] of EMA

There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. LUMIGAN) to be reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin analogues (see section 4.4).

 

Bimatoprost, levobunolol

The co-administration may have an additive intraocular pressure lowering effect

 

Prostaglandin analogues, prostaglandin analogues ---> SmPC of [bimatoprost] of EMA

There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. LUMIGAN) to be reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin analogues (see section 4.4).

 

 

             CONTRAINDICATIONS of Bimatoprost (Lumigan)

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - LUMIGAN 0,1 mg/ml is contraindicated in patients who have had a suspected previous adverse reaction to benzalkonium chloride that has led to discontinuation.             

                          

             https://www.ema.europa.eu/en/documents/product-information/lumigan-epar-product-information_en.pdf  18/11/2024    

 


 

 


Bimatoprost/timolol (Ganfort)

Ability to drive, bimatoprost/timolol [2] ---> SmPC of [2] of EMA

As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines.

 

Adrenaline, betablockers ---> SmPC of [bimatoprost/timolol] of EMA

Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.

 

Amiodarone, bimatoprost/timolol [2] ---> SmPC of [2] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral anti-arrhythmics (including amiodarone)

 

Antiarrhythmics, bimatoprost/timolol [2] ---> SmPC of [2] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral anti-arrhythmics (including amiodarone)

 

Betablockers, bimatoprost/timolol [2] ---> SmPC of [2] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral beta-adrenergic blocking agents

 

Bimatoprost/timolol [1], breast-feeding ---> SmPC of [1] of EMA

GANFORT should not be used by breast-feeding women.

 

Bimatoprost/timolol [1], calcium antagonists ---> SmPC of [1] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers

 

Bimatoprost/timolol [1], digital glycosides ---> SmPC of [1] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral digitalis glycosides

 

Bimatoprost/timolol [1], fertility ---> SmPC of [1] of EMA

There are no data on the effects of GANFORT on human fertility.

 

Bimatoprost/timolol [1], fluoxetine ---> SmPC of [1] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

 

Bimatoprost/timolol [1], parasympathomimetics ---> SmPC of [1] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral parasympathomimetics

 

Bimatoprost/timolol [1], paroxetine ---> SmPC of [1] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

 

Bimatoprost/timolol [1], pregnancy ---> SmPC of [1] of EMA

GANFORT should not be used during pregnancy unless clearly necessary.

 

Bimatoprost/timolol [1], quinidine ---> SmPC of [1] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

 

Bimatoprost/timolol [1], strong CYP2D6 inhibitors ---> SmPC of [1] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

 

Calcium antagonists, timolol ---> SmPC of [bimatoprost/timolol] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers

 

Guanethidine, timolol ---> SmPC of [bimatoprost/timolol] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral guanethidine

 

Parasympathomimetics, timolol ---> SmPC of [bimatoprost/timolol] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral parasympathomimetics

 

Strong CYP2D6 inhibitors, timolol ---> SmPC of [bimatoprost/timolol] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

 

 

 

            CONTRAINDICATIONS of Bimatoprost/timolol (Ganfort)

            - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

            - Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.    

            - Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pace-maker. Overt cardiac failure, cardiogenic shock.

                       

            https://www.ema.europa.eu/en/documents/product-information/ganfort-epar-product-information_en.pdf 18/11/2024             

 





Bimekizumab (Bimzelx)

Bimekizumab [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Bimzelx therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Bimekizumab [1], CYP450 ---> SmPC of [1] of EMA

The formation of some CYP450 enzymes is suppressed by increased levels of cytokines during chronic inflammation.

 

Bimekizumab [1], CYP450 substrates with narrow therapeutic index ---> SmPC of [1] of EMA

A clinically relevant effect on CYP450 substrates with a narrow therapeutic index, in which the dose is individually adjusted (e.g. warfarin) cannot be excluded.

 

Bimekizumab [1], DMARD ---> SmPC of [1] of EMA

The concomitant administration of conventional disease modifying antirheumatic drugs (cDMARDs) including methotrexate or prior exposure to biologics have no clinically relevant impact on the clearance of bimekizumab.

 

Bimekizumab [1], fertility ---> SmPC of [1] of EMA

Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).

 

Bimekizumab [1], methotrexate ---> SmPC of [1] of EMA

The concomitant administration of conventional disease modifying antirheumatic drugs (cDMARDs) including methotrexate or prior exposure to biologics have no clinically relevant impact on the clearance of bimekizumab.

 

Bimekizumab [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is preferable to avoid the use of Bimzelx during pregnancy.

 

Bimekizumab [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

Live vaccines should not be given in patients treated with bimekizumab. Patients treated with bimekizumab may receive inactivated or non-live vaccinations.

 

Bimekizumab [1], warfarin ---> SmPC of [1] of EMA

A clinically relevant effect on CYP450 substrates with a narrow therapeutic index, in which the dose is individually adjusted (e.g. warfarin) cannot be excluded.

 

Bimekizumab [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment.

 

 

 

            CONTRAINDICATIONS of Bimekizumab (Bimzelx)            

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Clinically important active infections (e.g. active tuberculosis, see section 4.4).    

 

            https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf 07/08/2024             

           




Binimetinib (Mektovi)

Ability to drive, binimetinib [2] ---> SmPC of [2] of EMA

Patients should be advised not to drive or use machines if they experience visual disturbances or any other adverse reaction that may affect their ability to drive and use machines

 

Atazanavir [1], binimetinib ---> SmPC of [1] of EMA

UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.

 

Binimetinib [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue Mektovi therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.

 

Binimetinib [1], carbamazepine ---> SmPC of [1] of EMA

Inducers of CYP1A2 enzymes (such as carbamazepine and rifampicin) may decrease binimetinib exposure, which could result in a decrease of efficacy.

 

Binimetinib [1], ciprofloxacin ---> SmPC of [1] of EMA

Binimetinib is a weak inhibitor of OAT3, and caution should be taken when it is used with sensitive substrates (such as pravastatin or ciprofloxacin).

 

Binimetinib [1], CYP1A2 inductors ---> SmPC of [1] of EMA

Inducers of CYP1A2 enzymes (such as carbamazepine and rifampicin) may decrease binimetinib exposure, which could result in a decrease of efficacy.

 

Binimetinib [1], duloxetine ---> SmPC of [1] of EMA

Binimetinib is a potential inducer of CYP1A2, and caution should be taken when it is used with sensitive substrates (such as duloxetine or theophylline).

 

Binimetinib [1], fertility ---> SmPC of [1] of EMA

There are no data on the effect on fertility in humans for binimetinib.

 

Binimetinib [1], indinavir ---> SmPC of [1] of EMA

UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.

 

Binimetinib [1], P-gp inductors ---> SmPC of [1] of EMA

Inducers of Pgp transport (such as Saint John's wort or phenytoin) may decrease binimetinib exposure, which could result in a decrease of efficacy.

 

Binimetinib [1], phenobarbital ---> SmPC of [1] of EMA

UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.

 

Binimetinib [1], phenytoin ---> SmPC of [1] of EMA

Inducers of Pgp transport (such as Saint John's wort or phenytoin) may decrease binimetinib exposure, which could result in a decrease of efficacy.

 

Binimetinib [1], pravastatine ---> SmPC of [1] of EMA

Binimetinib is a weak inhibitor of OAT3, and caution should be taken when it is used with sensitive substrates (such as pravastatin or ciprofloxacin).

 

Binimetinib [1], pregnancy ---> SmPC of [1] of EMA

Binimetinib is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

Binimetinib [1], pregnancy ---> SmPC of [1] of EMA

If binimetinib is used during pregnancy, or if the patient becomes pregnant while taking binimetinib, the patient should be informed of the potential hazard to the foetus.

 

Binimetinib [1], rifampicin ---> SmPC of [1] of EMA

UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.

 

Binimetinib [1], rifampicin ---> SmPC of [1] of EMA

Inducers of CYP1A2 enzymes (such as carbamazepine and rifampicin) may decrease binimetinib exposure, which could result in a decrease of efficacy.

 

Binimetinib [1], sorafenib ---> SmPC of [1] of EMA

UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.

 

Binimetinib [1], St. John's wort ---> SmPC of [1] of EMA

Inducers of Pgp transport (such as Saint John's wort or phenytoin) may decrease binimetinib exposure, which could result in a decrease of efficacy.

 

Binimetinib [1], theophylline ---> SmPC of [1] of EMA

Binimetinib is a potential inducer of CYP1A2, and caution should be taken when it is used with sensitive substrates (such as duloxetine or theophylline).

 

Binimetinib [1], UGT1A1 inductors ---> SmPC of [1] of EMA

UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.

 

Binimetinib [1], UGT1A1 inhibitors ---> SmPC of [1] of EMA

UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.

 

Binimetinib [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential must use effective contraception during treatment with binimetinib and for at least 1 month following the last dose.

 

Binimetinib, encorafenib [2] ---> SmPC of [2] of EMA

While encorafenib is a relatively potent reversible inhibitor of UGT1A1, no differences in binimetinib exposure have been observed clinically when binimetinib was co-administered with encorafenib.

 

 

 

            CONTRAINDICATIONS of Binimetinib (Mektovi)    

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

            https://www.ema.europa.eu/en/documents/product-information/mektovi-epar-product-information_en.pdf 05/11/2025 

 





 

Biotin

 

Antiepileptics, biotin

Decreased absorption of biotin and decreased effect of antiepileptic medicine

 

Avidin, biotin

Decreased absorption of biotin

 

Biotin, breast-feeding

There has been described no problems with the intake of the recommended doses

 

Biotin, pregnancy

There has been described no problems with the intake of the recommended doses

 

Biotin, raw egg-white

Decreased effect of biotin

 



 


Extract from birch bark (Episalvan)

Breast-feeding, extract from birch bark [2] ---> SmPC of [2] of EMA

Episalvan can be used during breast-feeding, unless the chest area is subject to treatment.

 

Extract from birch bark [1], fertility ---> SmPC of [1] of EMA

Fertility studies have not been conducted. No effects on human fertility are anticipated, since the systemic exposure is negligible.

 

Extract from birch bark [1], pregnancy ---> SmPC of [1] of EMA

Episalvan can be used during pregnancy.

 

Extract from birch bark [1], topical products ---> SmPC of [1] of EMA

Other topical products should not be concomitantly used together with Episalvan but rather sequentially or alternatively depending on the clinical need.

 

 

 

            CONTRAINDICATIONS of Extract from birch bark (Episalvan)    

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

            https://www.ema.europa.eu/en/documents/product-information/episalvan-epar-product-information_en.pdf 15/07/2022 (withdrawn)    

 


 

 

Bisacodyl

 

H2 antagonists, bisacodyl [2] ---> SPC of [2] of eMC

The concomitant use of antacids may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation.

 

Ability to drive, bisacodyl [2] ---> SPC of [2] of eMC

Patients should be advised that due to a vasovagal response (e.g. to abdominal spasm) they may experience dizziness and / or syncope.

 

Amphotericin B, bisacodyl [2] ---> SPC of [2] of eMC

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of bisacodyl are taken.

 

Antacids, bisacodyl [2] ---> SPC of [2] of eMC

The concomitant use of antacids may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation.

 

Antiarrhythmics, bisacodyl

Hypokalaemia (described in association with chronic laxative abuse) interacts with antiarrhythmics (e. g. quinidine)

 

Antibiotics, bisacodyl

The co-administration may decrease the laxative effect

 

Antiepileptics, bisacodyl

The co-administration may decrease the absorption of the antiepileptic agent

 

Bisacodyl [1], breast-feeding ---> SPC of [1] of eMC

Bisacodyl should not be taken during breast feeding unless the expected benefit is thought to outweigh any possible risk and only on medical advice.

 

Bisacodyl [1], calcium ---> SPC of [1] of eMC

The concomitant use of antacids and milk products may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation.

 

Bisacodyl [1], cardiac glycosides ---> SPC of [1] of eMC

Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

 

Bisacodyl [1], corticosteroids ---> SPC of [1] of eMC

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of bisacodyl are taken.

 

Bisacodyl [1], digoxin ---> SPC of [1] of eMC

Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

 

Bisacodyl [1], diuretics ---> SPC of [1] of eMC

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of bisacodyl are taken.

 

Bisacodyl [1], glucocorticoids ---> SPC of [1] of eMC

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of bisacodyl are taken.

 

Bisacodyl [1], glycyrrhiza ---> SPC of [1] of eMC

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of bisacodyl are taken.

 

Bisacodyl [1], hypokalemia ---> SPC of [1] of eMC

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of bisacodyl are taken.

 

Bisacodyl [1], loop diuretics ---> SPC of [1] of eMC

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of bisacodyl are taken.

 

Bisacodyl [1], milk ---> SPC of [1] of eMC

The concomitant use milk products and bisacodyl may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation.

 

Bisacodyl [1], non-potassium-sparing diuretics ---> SPC of [1] of eMC

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of bisacodyl are taken.

 

Bisacodyl, oral anticoagulants

The co-administration may decrease the absorption of the oral anticoagulant agent

 

Bisacodyl, oral antidiabetics

The co-administration may decrease the absorption of the oral antidiabetic agent

 

Bisacodyl, oral contraceptives

The co-administration may decrease the absorption of the oral contraceptive

 

Bisacodyl [1], pregnancy ---> SPC of [1] of eMC

Bisacodyl should not be taken in pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh any possible risk and only on medical advice.

 

Bisacodyl [1], proton pump inhibitors ---> SPC of [1] of eMC

The concomitant use of antacids may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation.

 

Bisacodyl, quinidine

Hypokalaemia (described in association with chronic laxative abuse) interacts with antiarrhythmics (e. g. quinidine)

 

Bisacodyl [1], stimulant laxatives ---> SPC of [1] of eMC

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of bisacodyl are taken.

 

Bisacodyl [1], thiazides ---> SPC of [1] of eMC

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of bisacodyl are taken.

 

 

           CONTRAINDICATIONS of Bisacodyl

            

           - DULCOLAX is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions.

           - DULCOLAX is also contraindicated in severe dehydration and in patients with known hypersensitivity to bisacodyl or any other component of the product.

            

           http://www.medicines.org.uk/emc/


 

 

Bisoprolol

 

IMAOs, betablockers ---> SPC of [bisoprolol] of eMC

Combination of a MAO inhibitor with a beta-blocker can cause an increase of the pharmacodynamic effects and an increase in blood pressure up to hypertension crises.

 

IMAOs, bisoprolol [2] ---> SPC of [2] of eMC

Concomitant use of monoamine oxidase inhibitors (except MAO-B inhibitors) and bisoprolol enhances hypotensive effect of the beta-blocking agents, but also risk for hypertensive crisis.

 

NSAID, bisoprolol [2] ---> SPC of [2] of eMC

NSAIDs may reduce the hypotensive effect of bisoprolol.

 

Ability to drive, bisoprolol [2] ---> SPC of [2] of eMC

Depending on the individual patient's response the ability to drive a vehicle or to use machines may be impaired.

 

Adrenaline, bisoprolol [2] ---> SPC of [2] of eMC

Combination with bisoprolol may unmask the alfa-adrenoceptor-mediated vasoconstrictor effects leading to blood pressure increase and exacerbated intermittent claudication.

 

Alcohol, bisoprolol

The effect of bisoprolol can be potentiated by alcohol

 

Alfa and beta-adrenergic agonists, bisoprolol [2] ---> SPC of [2] of eMC

Combination with bisoprolol may unmask the alfa-adrenoceptor-mediated vasoconstrictor effects leading to blood pressure increase and exacerbated intermittent claudication.

 

Amiodarone, bisoprolol [2] ---> SPC of [2] of eMC

The combination of class-III antiarrhythmic medicinal products with bisoprolol may potentiate the effect on atrio-ventricular conduction time

 

Amlodipine, bisoprolol [2] ---> SPC of [2] of eMC

The combination may increase the risk of hypotension, and an increase in the risk of a further deterioration of the ventricular pump function in patients with heart failure cannot be excluded

 

Anaesthetics, bisoprolol [2] ---> SPC of [2] of eMC

Attenuation of the reflex tachycardia and increase of the risk of hypotension

 

Antihypertensives, bisoprolol [2] ---> SPC of [2] of eMC

Concomitant use of bisoprolol with antihypertensive agents as well as with other medicinal products with blood pressure lowering potential may increase the risk of hypotension.

 

Baclofen, bisoprolol

The co-administration may increase the risk of hypotension

 

Barbiturates, bisoprolol [2] ---> SPC of [2] of eMC

Concomitant use of bisoprolol with antihypertensive agents as well as with other medicinal products with blood pressure lowering potential may increase the risk of hypotension.

 

Benzothiazepines, bisoprolol [2] ---> SPC of [2] of eMC

Negative influence on contractility and atrio-ventricular conduction.

 

Beta-adrenergic agonists, bisoprolol [2] ---> SPC of [2] of eMC

Combination of beta-sympathomimetic agents with bisoprolol may reduce the effect of both agents.

 

Betablockers, bisoprolol [2] ---> SPC of [2] of eMC

Topical beta-blocking agents (e.g. eye drops for glaucoma treatment) may add to the systemic effects of bisoprolol.

 

Bisoprolol [1], breast-feeding ---> SPC of [1] of eMC

Breastfeeding is not recommended during administration of bisoprolol.

 

Bisoprolol [1], centrally-acting antihypertensives ---> SPC of [1] of eMC

Concomitant use of centrally-acting antihypertensive and bisoprolol may worsen heart failure by a decrease in the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation)

 

Bisoprolol, cimetidine

The effect of bisoprolol can be potentiated by cimetidine

 

Bisoprolol [1], class IA antiarrhythmic agents ---> SPC of [1] of eMC

Class I antiarrhythmic may potentiate the effect on atrio-ventricular conduction time and increase the negative inotropic effect

 

Bisoprolol [1], class IB antiarrhythmic agents ---> SPC of [1] of eMC

Class I antiarrhythmic may potentiate the effect on atrio-ventricular conduction time and increase the negative inotropic effect

 

Bisoprolol [1], class IC antiarrhythmic agents ---> SPC of [1] of eMC

Class I antiarrhythmic may potentiate the effect on atrio-ventricular conduction time and increase the negative inotropic effect

 

Bisoprolol [1], class III antiarrhythmic agents ---> SPC of [1] of eMC

The combination of class-III antiarrhythmic medicinal products with bisoprolol may potentiate the effect on atrio-ventricular conduction time

 

Bisoprolol [1], clonidine ---> SPC of [1] of eMC

Concomitant use of centrally-acting antihypertensive and bisoprolol may worsen heart failure by a decrease in the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation)

 

Bisoprolol, corticosteroids

Decreased antihypertensive effect due to water and sodium retention

 

Bisoprolol [1], digital glycosides ---> SPC of [1] of eMC

Reduction of heart rate, increase of atrio-ventricular conduction time.

 

Bisoprolol [1], dihydropyridines ---> SPC of [1] of eMC

The combination may increase the risk of hypotension, and an increase in the risk of a further deterioration of the ventricular pump function in patients with heart failure cannot be excluded

 

Bisoprolol [1], diltiazem ---> SPC of [1] of eMC

Negative influence on contractility and atrio-ventricular conduction.

 

Bisoprolol [1], doubutamine ---> SPC of [1] of eMC

Combination of beta-sympathomimetic agents with bisoprolol may reduce the effect of both agents.

 

Bisoprolol, enzalutamide [2] ---> SPC of [2] of EMA

Enzalutamide, enzymatic inductor, may increase the metabolism of bisoprolol and decrease its plasma levels and effect

 

Bisoprolol [1], epinephrine ---> SPC of [1] of eMC

Combination with bisoprolol may unmask the alfa-adrenoceptor-mediated vasoconstrictor effects leading to blood pressure increase and exacerbated intermittent claudication.

 

Bisoprolol [1], ergot derivatives ---> SPC of [1] of eMC

Exacerbation of peripheral circulatory disturbances.

 

Bisoprolol [1], felodipine ---> SPC of [1] of eMC

The combination may increase the risk of hypotension, and an increase in the risk of a further deterioration of the ventricular pump function in patients with heart failure cannot be excluded

 

Bisoprolol [1], flecainide ---> SPC of [1] of eMC

Class I antiarrhythmic may potentiate the effect on atrio-ventricular conduction time and increase the negative inotropic effect

 

Bisoprolol, floctafenine

Bisoprolol may impede the compensatory cardiovascular reactions associated with hypotension/shock that may be induced by floctafenine. The combination is contraindicated

 

Bisoprolol [1], guanfacin ---> SPC of [1] of eMC

Concomitant use of centrally-acting antihypertensive and bisoprolol may worsen heart failure by a decrease in the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation)

 

Bisoprolol, hydralazine

The effect of bisoprolol can be potentiated by hydralazine

 

Bisoprolol, hydroquinidine

Negative inotropic effect with risk of decompensated cardiac failure (synergistic effects). The co-administration is contraindicated

 

Bisoprolol [1], insulin ---> SPC of [1] of eMC

Increase of blood sugar lowering effect. Blockade of beta-adrenoceptors may mask symptoms of hypoglycaemia.

 

Bisoprolol [1], isoprenaline ---> SPC of [1] of eMC

Combination of beta-sympathomimetic agents with bisoprolol may reduce the effect of both agents.

 

Bisoprolol [1], lidocaine ---> SPC of [1] of eMC

Class I antiarrhythmic may potentiate the effect on atrio-ventricular conduction time and increase the negative inotropic effect

 

Bisoprolol [1], mefloquine ---> SPC of [1] of eMC

Increased risk of bradycardia

 

Bisoprolol [1], methyldopa ---> SPC of [1] of eMC

Concomitant use of centrally-acting antihypertensive and bisoprolol may worsen heart failure by a decrease in the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation)

 

Bisoprolol [1], moxonidine ---> SPC of [1] of eMC

Concomitant use of centrally-acting antihypertensive and bisoprolol may worsen heart failure by a decrease in the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation)

 

Bisoprolol [1], noradrenaline ---> SPC of [1] of eMC

Combination with bisoprolol may unmask the alfa-adrenoceptor-mediated vasoconstrictor effects leading to blood pressure increase and exacerbated intermittent claudication.

 

Bisoprolol [1], norepinephrine ---> SPC of [1] of eMC

Combination with bisoprolol may unmask the alfa-adrenoceptor-mediated vasoconstrictor effects leading to blood pressure increase and exacerbated intermittent claudication.

 

Bisoprolol [1], oral antidiabetics ---> SPC of [1] of eMC

Increase of blood sugar lowering effect. Blockade of beta-adrenoceptors may mask symptoms of hypoglycaemia.

 

Bisoprolol [1], parasympathomimetics ---> SPC of [1] of eMC

Concomitant use of bisoprolol and parasympathomimetic medicinal products may increase atrio-ventricular conduction time and the risk of bradycardia.

 

Bisoprolol [1], phenothiazines ---> SPC of [1] of eMC

Concomitant use of bisoprolol with antihypertensive agents as well as with other medicinal products with blood pressure lowering potential may increase the risk of hypotension.

 

Bisoprolol [1], phenylalkylamines ---> SPC of [1] of eMC

Negative influence on contractility and atrio-ventricular conduction.

 

Bisoprolol [1], phenytoin ---> SPC of [1] of eMC

Class I antiarrhythmic may potentiate the effect on atrio-ventricular conduction time and increase the negative inotropic effect

 

Bisoprolol [1], pregnancy ---> SPC of [1] of eMC

Bisoprolol is not recommended during pregnancy unless clearly necessary.

 

Bisoprolol [1], propafenone ---> SPC of [1] of eMC

Class I antiarrhythmic may potentiate the effect on atrio-ventricular conduction time and increase the negative inotropic effect

 

Bisoprolol [1], quinidine ---> SPC of [1] of eMC

Class I antiarrhythmic may potentiate the effect on atrio-ventricular conduction time and increase the negative inotropic effect

 

Bisoprolol [1], rifampicin ---> SPC of [1] of eMC

Slight reduction of the half-life of bisoprolol possible due to the induction of hepatic drug-metabolising enzymes. Normally no dosage adjustment is necessary.

 

Bisoprolol [1], rilmenidine ---> SPC of [1] of eMC

Concomitant use of centrally-acting antihypertensive and bisoprolol may worsen heart failure by a decrease in the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation)

 

Bisoprolol, strong CYP3A4 inductors

The CYP3A4-induction may decrease plasma levels of bisoprolol

 

Bisoprolol, sultopride

Increased risk of ventricular arrhythmias. Combination contraindicated

 

Bisoprolol, tiapride

Tiapride with betablockers given in heart failure increases the risk of ventricular arrhythmias, particularly torsades de pointes. Clinical and electrocardiographic monitoring is necessary

 

Bisoprolol [1], tricyclic antidepressant ---> SPC of [1] of eMC

Concomitant use of bisoprolol with antihypertensive agents as well as with other medicinal products with blood pressure lowering potential may increase the risk of hypotension.

 

Bisoprolol [1], verapamil ---> SPC of [1] of eMC

Intravenous administration of verapamil in patients on beta-blocker treatment may lead to profound hypotension and atrioventricular block.

 

 

           CONTRAINDICATIONS of Bisoprolol

            

           Bisoprolol is contraindicated in:

           - acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy

           - cardiogenic shock

           - AV block of second or third degree

           - sick sinus syndrome

           - sinoatrial block

           - symptomatic bradycardia

           - symptomatic hypotension

           - severe bronchial asthma or severe chronic obstructive pulmonary disease

           - severe forms of peripheral arterial occlusive disease or severe forms of Raynaud's syndrome

           - untreated phaeochromocytoma

           - metabolic acidosis

           - hypersensitivity to the active substance or to any of the excipients

            

           http://www.medicines.org.uk/emc/


 


Bivalirudin (Angiox)

Anticoagulants, bivalirudin [2] ---> SmPC of [2] of EMA

From the knowledge of their mechanism of action, combined use of anti-coagulant medicinal products (heparin, warfarin, thrombolytics or antiplatelet agents) can be expected to increase the risk of bleeding.

 

Bivalirudin [1], breast-feeding ---> SmPC of [1] of EMA

It is unknown whether bivalirudin is excreted in human milk. Angiox should be administered with caution in breast-feeding mothers.

 

Bivalirudin [1], heparin ---> SmPC of [1] of EMA

From the knowledge of their mechanism of action, combined use of anti-coagulant medicinal products (heparin, warfarin, thrombolytics or antiplatelet agents) can be expected to increase the risk of bleeding.

 

Bivalirudin [1], platelet aggregation inhibitors ---> SmPC of [1] of EMA

Interaction studies have been conducted with platelet inhibitors, including acetylsalicylic acid, ticlopidine, clopidogrel, abciximab, eptifibatide, or tirofiban. The results do not suggest pharmacodynamic interactions with these medicinal products.

 

Bivalirudin [1], pregnancy ---> SmPC of [1] of EMA

Angiox should not be used during pregnancy unless the clinical condition of the woman requires treatment with bivalirudin.

 

Bivalirudin [1], thrombolytics ---> SmPC of [1] of EMA

From the knowledge of their mechanism of action, combined use of anti-coagulant medicinal products (heparin, warfarin, thrombolytics or antiplatelet agents) can be expected to increase the risk of bleeding.

 

Bivalirudin [1], warfarin ---> SmPC of [1] of EMA

From the knowledge of their mechanism of action, combined use of anti-coagulant medicinal products (heparin, warfarin, thrombolytics or antiplatelet agents) can be expected to increase the risk of bleeding.

 

Bivalirudin, cangrelor [2] ---> SmPC of [2] of EMA

In clinical studies, cangrelor has been co-administered with bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors with no apparent effect upon the pharmacokinetics or pharmacodynamics of cangrelor.

 

Bivalirudin, prasugrel [2] ---> SmPC of [2] of EMA

Efient has been co-administered in the phase 3 clinical trial with low molecular weight heparin, bivalirudin, and GP IIb/IIIa inhibitors without evidence of clinically significant adverse interactions.

 

 

 

             CONTRAINDICATIONS of Bivalirudin (Angiox)

             Angiox is contraindicated in patients with:       

             - a known hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to hirudins              

             - active bleeding or increased risk of bleeding because of haemostasis disorders and/or irreversible coagulation disorders         

             - severe uncontrolled hypertension   

             - subacute bacterial endocarditis          

             - severe renal impairment (GFR<30 ml/min) and in dialysis-dependent patients.         

                          

             https://www.ema.europa.eu/en/documents/product-information/angiox-epar-product-information_en.pdf 14/09/2018 (withdrawn)           

 

 

            

Bleomycin

 

Ability to drive, bleomycin [2] ---> SPC of [2] of eMC

This depends on the patient's condition and should be considered in co-operation with the doctor.

 

Acetyldigoxin, bleomycin

Decreased bioavailibility of acetyldigoxin

 

Allopurinol [1], bleomycin ---> SPC of [1] of eMC

Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease (other than leukaemia), in the presence of allopurinol.

 

Allopurinol/lesinurad [1], bleomycin ---> SPC of [1] of EMA

With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood dyscrasias occur more frequently than when these active substances are administered alone.

 

Aminophylline, bleomycin

Incompatibility

 

Ascorbic acid, bleomycin

Bleomycin may be in vitro inactivated by ascorbic acid

 

Benzylpenicillin, bleomycin

Incompatibility

 

Bleomycin [1], breast-feeding ---> SPC of [1] of eMC

Bleomycin should not normally be administered to mothers who are breast-feeding.

 

Bleomycin, brentuximab vedotin [2] ---> SPC of [2] of EMA

Combined use of bleomycin and brentuximab vedotin causes pulmonary toxicity and is contraindicated

 

Bleomycin, carbenicillin

Incompatibility

 

Bleomycin, carmustine

Increased risk of pulmonary toxicity with pulmotoxic substances

 

Bleomycin [1], cisplatin ---> SPC of [1] of eMC

During or after treatment with cisplatin caution is advised with predominantly renal eliminated substances because of potentially reduced renal elimination.

 

Bleomycin, cyclophosphamide

Increased risk of pulmonary toxicity with pulmotoxic substances

 

Bleomycin, cyclosporine

Exaggerated immunosuppression with risk of lymphoproliferation

 

Bleomycin, digoxin

Decreased bioavailibility of digoxin

 

Bleomycin, divalent cations

Incompatibility

 

Bleomycin, essential amino acid

Incompatibility

 

Bleomycin, etoposide

The co-administration may enhance the cytotoxic and myelosuppressive effects

 

Bleomycin, fosphenytoin

The combination may decrease the absorption of phenytoin and exacerbate the convulsions. Phenytoin may increase the toxicity or decrease the effect of the cytotoxic agent

 

Bleomycin, furosemide

Incompatibility

 

Bleomycin, gemcitabine

Increased risk of pulmonary toxicity with pulmotoxic substances

 

Bleomycin, glutathione

Incompatibility

 

Bleomycin, hydrocortisone

Incompatibility

 

Bleomycin, immunosuppressives

The co-administration with other myelosuppressive may increase the myelotoxicity

 

Bleomycin, macrosalb

Toxicological interactions may occur

 

Bleomycin, methotrexate

Increased risk of pulmonary toxicity with pulmotoxic substances

 

Bleomycin, mytomicin

Increased risk of pulmonary toxicity with pulmotoxic substances

 

Bleomycin, nafcillin

Incompatibility

 

Bleomycin, nephrotoxic substances

Possible increase of toxicity risk because of decreased elimination of bleomycin due to nephrotoxic comedication

 

Bleomycin, nitrous oxide

The pulmonary toxicity of bleomycin may be exacerbated by inhalation of high oxygen concentrations

 

Bleomycin [1], oxygen ---> SPC of [1] of eMC

Because of bleomycin sensitization of lung tissue, patients who have received bleomycin pre-operatively are at greater risk of developing pulmonary toxicity when oxygen is administered at surgery

 

Bleomycin [1], oxygen therapy ---> SPC of [1] of eMC

Because of bleomycin sensitization of lung tissue, patients who have received bleomycin pre-operatively are at greater risk of developing pulmonary toxicity when oxygen is administered at surgery

 

Bleomycin, phenytoin

The combination may decrease the absorption of phenytoin and exacerbate the convulsions. Phenytoin may increase the toxicity or decrease the effect of the cytotoxic agent

 

Bleomycin [1], pregnancy ---> SPC of [1] of eMC

Bleomycin should not normally be administered to patients who are pregnant

 

Bleomycin, primidone

The co-administration may decrease the plasma levels of primidone

 

Bleomycin, pulmotoxic substances

Increased risk of pulmonary toxicity with pulmotoxic substances

 

Bleomycin [1], radiotherapy ---> SPC of [1] of eMC

Previous or concurrent radiotherapy to the chest is an important factor in increasing the incidence and severity of lung toxicity.

 

Bleomycin, riboflavin

Bleomycin may be in vitro inactivated by riboflavin

 

Bleomycin, tacrolimus

Exaggerated immunosuppression with risk of lymphoproliferation

 

Bleomycin, terbutaline

Incompatibility

 

Bleomycin, trivalent cations

Incompatibility

 

Bleomycin, vaccinations with live organism vaccines

Live vaccines must not be administered to a patient receiving an immunosuppressive chemotherapeutic agent

 

Bleomycin [1], vinca alkaloids ---> SPC of [1] of eMC

In patients treated for testicular cancer with a combination of bleomycin and vinca alkaloids a syndrome has been reported corresponding to morbus Raynaud

 

Bleomycin, vincristine

In the combination with bleomycin, vincristine may cause dose-dependent a Raynaud syndrome

 

Bleomycin, yellow fever vaccine

Live vaccines must not be administered to a patient receiving an immunosuppressive chemotherapeutic agent

 

 

           CONTRAINDICATIONS of Bleomycin

            

           - Bleomycin is contra-indicated in patients with acute pulmonary infection or greatly reduced lung function

           - Patients who have previously had a hypersensitivity or idiosyncratic reaction to bleomycin.

            

           http://www.medicines.org.uk/emc/






Blinatumomab (Blincyto)

Ability to drive, blinatumomab [2] ---> SmPC of [2] of EMA

Due to the potential for neurologic events, patients receiving blinatumomab should refrain from driving, engaging in hazardous occupations or activities such as driving or operating heavy or potentially dangerous machinery

 

Blinatumomab [1], breast-feeding ---> SmPC of [1] of EMA

As a precautionary measure, breast-feeding is contra-indicated during and for at least 48 hours after treatment with blinatumomab.

 

Blinatumomab [1], cyclosporine ---> SmPC of [1] of EMA

Patients who are receiving medicinal products that are CYP450 and transporter substrates with a narrow therapeutic index should be monitored for adverse effects (e.g. warfarin) or drug concentrations (e.g. cyclosporine) during this time.

 

Blinatumomab [1], CYP450 substrates ---> SmPC of [1] of EMA

Patients who are receiving medicinal products that are CYP450 and transporter substrates with a narrow therapeutic index should be monitored for adverse effects (e.g. warfarin) or drug concentrations (e.g. cyclosporine) during this time.

 

Blinatumomab [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of EMA

Patients who are receiving medicinal products that are CYP450 and transporter substrates with a narrow therapeutic index should be monitored for adverse effects (e.g. warfarin) or drug concentrations (e.g. cyclosporine) during this time.

 

Blinatumomab [1], fertility ---> SmPC of [1] of EMA

No studies have been conducted to evaluate the effects of blinatumomab on fertility. No adverse effects on male or female mouse reproductive organs in 13-week toxicity studies with the murine surrogate molecule (see section 5.3).

 

Blinatumomab [1], pancreatitis ---> SmPC of [1] of EMA

Pancreatitis, life-threatening or fatal, has been reported in patients receiving BLINCYTO in clinical trials and the post-marketing setting. High-dose steroid therapy may have contributed, in some cases, to the pancreatitis.

 

Blinatumomab [1], pregnancy ---> SmPC of [1] of EMA

Blinatumomab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.

 

Blinatumomab [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO treatment, during treatment, and until recovery of B lymphocytes to normal ranges following last treatment cycle.

 

Blinatumomab [1], warfarin ---> SmPC of [1] of EMA

Patients who are receiving medicinal products that are CYP450 and transporter substrates with a narrow therapeutic index should be monitored for adverse effects (e.g. warfarin) or drug concentrations (e.g. cyclosporine) during this time.

 

Blinatumomab [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential have to use effective contraception during and for at least 48 hours after treatment with blinatumomab (see section 4.4).

 

 

 

             CONTRAINDICATIONS of Blinatumomab (Blincyto)

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Breast-feeding (see section 4.6).       

                          

             https://www.ema.europa.eu/en/documents/product-information/blincyto-epar-product-information_en.pdf 15/01/2026






Boceprevir (Victrelis)

Ability to drive, boceprevir [2] ---> SmPC of [2] of EMA

Patients should be informed that fatigue, dizziness, syncope, blood pressure fluctuations and blurred vision have been reported (see section 4.8).

 

Aldo-keto reductase inhibitors, boceprevir [2] ---> SmPC of [2] of EMA

Boceprevir is primarily metabolized by aldo-keto reductase (AKR). In medicine interaction trials conducted with AKR inhibitors, boceprevir exposure did not increase to a clinically significant extent. Boceprevir may be co-administered with AKR inhibitors

 

Alfuzosin, boceprevir/peginterferon alfa/ribavirin ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Alprazolam, boceprevir [2] ---> SmPC of [2] of EMA

Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during co-administration of Victrelis with intravenous benzodiazepines. Dose adjustment of the benzodiazepine should be considered.

 

Amiodarone, boceprevir [2] ---> SmPC of [2] of EMA

Caution should be exercised with boceprevir and medicines known to prolong QT interval

 

Amlodipine, boceprevir [2] ---> SmPC of [2] of EMA

Boceprevir, CYP3A4 inhibitor, may increase the plasma concentrations of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.

 

Atazanavir/cobicistat [1], boceprevir ---> SmPC of [1] of EMA

Coadministration (not recommended) of EVOTAZ with moderate to weak inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir

 

Atazanavir/ritonavir, boceprevir [2] ---> SmPC of [2] of EMA

Co-administration of atazanavir/ritonavir with boceprevir resulted in lower exposure of atazanavir which may be associated with lower efficacy and loss of HIV control.

 

Atorvastatin, boceprevir

Exposure to atorvastatin was increased when administered with boceprevir.

 

Atorvastatin, boceprevir [2] ---> SmPC of [2] of EMA

Exposure to atorvastatin was increased when administered with Victrelis. When co-administration is required, starting with the lowest possible dose of atorvastatin should be considered with titration up to desired clinical effect while monitoring for saf

 

Avacopan [1], boceprevir ---> SmPC of [1] of EMA

Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.

 

Avapritinib [1], boceprevir ---> SmPC of [1] of EMA

Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib

 

Azole antifungals, boceprevir [2] ---> SmPC of [2] of EMA

The inhibition of CYP3A4 and P-glycoprotein may increase the plasma concentrations of boceprevir. Caution should be exercised when boceprevir is combined with azole antifungals

 

BCRP inhibitors, boceprevir [2] ---> SmPC of [2] of EMA

Boceprevir has been shown to be a p-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) substrate in vitro .There is potential for inhibitors of these transporters to increase concentrations of boceprevir

 

Bepridil, boceprevir/peginterferon alfa/ribavirin ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Bictegravir/emtricitabine/tenofovir alafenamide, boceprevir ---> SmPC of [boceprevir] of EMA

Co-administration is not recommended.

 

Boceprevir [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy with Victrelis taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Boceprevir [1], buprenorphine/naloxone ---> SmPC of [1] of EMA

No dose adjustment of buprenorphine/naloxone or Victrelis is recommended. Patients should be monitored for signs of opiate toxicity associated with buprenorphine

 

Boceprevir [1], calcium antagonists ---> SmPC of [1] of EMA

Boceprevir, CYP3A4 inhibitor, may increase the plasma concentrations of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.

 

Boceprevir [1], carbamazepine ---> SmPC of [1] of EMA

The concomitant use of boceprevir with carbamazepine may significantly reduce the plasma exposure of boceprevir. No data are available, therefore, the combination of boceprevir with these medicines is not-recommended

 

Boceprevir [1], cyclosporine ---> SmPC of [1] of EMA

The CYP3A4 inhibition by boceprevir increases the plasma levels of cyclosporine. Dose adjustments of cyclosporine should be anticipated when coadministered

 

Boceprevir [1], cytochrome P450 ---> SmPC of [1] of EMA

Victrelis does not inhibit or induce the other enzymes of the CYP450.

 

Boceprevir [1], diflunisal ---> SmPC of [1] of EMA

Boceprevir is primarily metabolized by aldo-keto reductase (AKR). In medicine interaction trials conducted with AKR inhibitors, boceprevir exposure did not increase to a clinically significant extent. Boceprevir may be co-administered with AKR inhibitors

 

Boceprevir [1], digoxin ---> SmPC of [1] of EMA

An increase in plasma concentrations of substrates of the P-gp efflux transporter, such as digoxin or dabigatran, should be anticipated (see table 2).

 

Boceprevir [1], diltiazem ---> SmPC of [1] of EMA

Boceprevir, CYP3A4 inhibitor, may increase the plasma concentrations of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.

 

Boceprevir [1], doxazosin ---> SmPC of [1] of EMA

The concomitant use of Victrelis with doxazosin or tamsulosin may increase plasma concentrations of these medicines. The combination of boceprevir with these medicines is not recommended (see section 4.4).

 

Boceprevir [1], drospirenone/ethinylestradiol ---> SmPC of [1] of EMA

Caution should be exercised in patients taking drospirenone-containing medicines with conditions that predispose them to hyperkalaemia or patients taking potassium-sparing diuretics. Alternative contraceptives should be considered

 

Boceprevir [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA

Medicines metabolized primarily by CYP3A4/5 may have increased exposure when administered with Victrelis, which could increase or prolong their therapeutic and adverse reactions

 

Boceprevir [1], efavirenz ---> SmPC of [1] of EMA

Plasma trough concentrations of Victrelis were decreased when administered with efavirenz. CYP3A induction - effect on boceprevir

 

Boceprevir [1], escitalopram ---> SmPC of [1] of EMA

Exposure of escitalopram was slightly decreased when co-administered with Victrelis. No dose adjustment of escitalopram is anticipated, but doses may need to be adjusted based on clinical effect

 

Boceprevir [1], etravirine ---> SmPC of [1] of EMA

Increased boceprevir plasma levels and decreased etravirine plasma levels. Increased clinical and laboratory monitoring for HIV and HCV suppression is recommended.

 

Boceprevir [1], felodipine ---> SmPC of [1] of EMA

Boceprevir, CYP3A4 inhibitor, may increase the plasma concentrations of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.

 

Boceprevir [1], fertility ---> SmPC of [1] of EMA

Available pharmacodynamic/toxicological data in rats have shown effects of boceprevir/metabolites on fertility, which in females have been shown to be reversible (see section 5.3).

 

Boceprevir [1], foods ---> SmPC of [1] of EMA

Victrelis is to be taken orally with food (a meal or light snack).

 

Boceprevir [1], ibuprofen ---> SmPC of [1] of EMA

Boceprevir is primarily metabolized by aldo-keto reductase (AKR). In medicine interaction trials conducted with AKR inhibitors, boceprevir exposure did not increase to a clinically significant extent. Boceprevir may be co-administered with AKR inhibitors

 

Boceprevir [1], intravenous benzodiazepines ---> SmPC of [1] of EMA

Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during co-administration of Victrelis with intravenous benzodiazepines. Dose adjustment of the benzodiazepine should be considered.

 

Boceprevir [1], itraconazol ---> SmPC of [1] of EMA

The inhibition of CYP3A4 and P-glycoprotein may increase the plasma concentrations of boceprevir. Caution should be exercised when boceprevir is combined with azole antifungals

 

Boceprevir [1], ketoconazole ---> SmPC of [1] of EMA

The inhibition of CYP3A4 and P-glycoprotein may increase the plasma concentrations of boceprevir. Caution should be exercised when boceprevir is combined with azole antifungals

 

Boceprevir [1], lopinavir/ritonavir ---> SmPC of [1] of EMA

Decreased plasma concentrations of boceprevir and lopinavir. Co-administration is not recommended

 

Boceprevir [1], men ---> SmPC of [1] of EMA

Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded.

 

Boceprevir [1], methadone ---> SmPC of [1] of EMA

Individual patients may require additional titration of their methadone dosage when Victrelis is started or stopped to ensure clinical effect of methadone.

 

Boceprevir [1], midazolam ---> SmPC of [1] of EMA

Co-administration of oral midazolam and oral triazolam with Victrelis is contraindicated

 

Boceprevir [1], nicardipine ---> SmPC of [1] of EMA

Boceprevir, CYP3A4 inhibitor, may increase the plasma concentrations of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.

 

Boceprevir [1], nifedipine ---> SmPC of [1] of EMA

Boceprevir, CYP3A4 inhibitor, may increase the plasma concentrations of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.

 

Boceprevir [1], nisoldipine ---> SmPC of [1] of EMA

Boceprevir, CYP3A4 inhibitor, may increase the plasma concentrations of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.

 

Boceprevir [1], norethisterone/ethinylestradiol ---> SmPC of [1] of EMA

Co-administration of boceprevir with an oral contraceptive containing ethinyl estradiol and at least 1 mg of norethindrone is unlikely to alter the contraceptive effectiveness.

 

Boceprevir [1], omeprazole ---> SmPC of [1] of EMA

No dosage adjustment necessary.

 

Boceprevir [1], P-glycoprotein substrates ---> SmPC of [1] of EMA

An increase in plasma concentrations of substrates of the P-gp efflux transporter, such as digoxin or dabigatran, should be anticipated (see table 2).

 

Boceprevir [1], pentamidine ---> SmPC of [1] of EMA

Caution should be exercised with boceprevir and medicines known to prolong QT interval

 

Boceprevir [1], phenobarbital ---> SmPC of [1] of EMA

The concomitant use of boceprevir with phenobarbital may significantly reduce the plasma exposure of boceprevir. No data are available, therefore, the combination of boceprevir with these medicines is not-recommended

 

Boceprevir [1], phenytoin ---> SmPC of [1] of EMA

The concomitant use of boceprevir with phenytoin may significantly reduce the plasma exposure of boceprevir. No data are available, therefore, the combination of boceprevir with these medicines is not-recommended

 

Boceprevir [1], posaconazole ---> SmPC of [1] of EMA

The inhibition of CYP3A4 and P-glycoprotein may increase the plasma concentrations of boceprevir. Caution should be exercised when boceprevir is combined with azole antifungals

 

Boceprevir [1], pravastatine ---> SmPC of [1] of EMA

Concomitant administration of pravastatin with Victrelis increased exposure to pravastatin. Treatment with pravastatin can be initiated at the recommended dose when co-administered with Victrelis. Close clinical monitoring is warranted.

 

Boceprevir [1], prednisolone ---> SmPC of [1] of EMA

The co-administration may increase the plasma levels of prednisolone. No dosage adjustment necessary

 

Boceprevir [1], prednisone ---> SmPC of [1] of EMA

The co-administration may increase the plasma levels of prednisone. No dosage adjustment necessary

 

Boceprevir [1], pregnancy ---> SmPC of [1] of EMA

Boceprevir in combination with ribavirin and peginterferon alfa is contraindicated in women who are pregnant

 

Boceprevir [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Caution should be exercised with boceprevir and medicines known to prolong QT interval

 

Boceprevir [1], quetiapine ---> SmPC of [1] of EMA

Concomitant administration of Victrelis and quetiapine may increase plasma concentrations of quetiapine leading to quetiapine-related toxicity, including coma. Coadministration of quetiapine with Victrelis is contraindicated

 

Boceprevir [1], quinidine ---> SmPC of [1] of EMA

Caution should be exercised with boceprevir and medicines known to prolong QT interval

 

Boceprevir [1], raltegravir ---> SmPC of [1] of EMA

Since the clinical relevance of the boceprevir C8h decrease has not been established, increased clinical and laboratory monitoring for HCV suppression is recommended.

 

Boceprevir [1], rifampicin ---> SmPC of [1] of EMA

The concomitant use of boceprevir with rifampicin may significantly reduce the plasma exposure of boceprevir. No data are available, therefore, the combination of boceprevir with these medicines is not-recommended

 

Boceprevir [1], rilpivirine ---> SmPC of [1] of EMA

The CYP3A4 inhibition increases the plasma concentrations of rilpivirine. No dosage adjustment necessary.

 

Boceprevir [1], ritonavir ---> SmPC of [1] of EMA

When boceprevir is administered with ritonavir alone, boceprevir concentrations are decreased.

 

Boceprevir [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

Victrelis is partly metabolized by CYP3A4/5. Co-administration of Victrelis with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure to Victrelis (see section 4.4).

 

Boceprevir [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Victrelis is partly metabolized by CYP3A4/5. Co-administration of Victrelis with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure to Victrelis (see section 4.4).

 

Boceprevir [1], strong P-gp inhibitors ---> SmPC of [1] of EMA

Boceprevir has been shown to be a p-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) substrate in vitro .There is potential for inhibitors of these transporters to increase concentrations of boceprevir

 

Boceprevir [1], tacrolimus ---> SmPC of [1] of EMA

The CYP3A4 inhibition by boceprevir increases the tacrolimus plasma levels. The combination requires significant dose reduction and prolongation of the dosing interval for tacrolimus

 

Boceprevir [1], tamsulosin ---> SmPC of [1] of EMA

The concomitant use of Victrelis with doxazosin or tamsulosin may increase plasma concentrations of these medicines. The combination of boceprevir with these medicines is not recommended (see section 4.4).

 

Boceprevir [1], tenofovir ---> SmPC of [1] of EMA

No dose adjustment required for Victrelis or tenofovir.

 

Boceprevir [1], triazolam ---> SmPC of [1] of EMA

Co-administration of oral midazolam and oral triazolam with Victrelis is contraindicated

 

Boceprevir [1], verapamil ---> SmPC of [1] of EMA

Boceprevir, CYP3A4 inhibitor, may increase the plasma concentrations of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.

 

Boceprevir [1], vitamin K antagonists ---> SmPC of [1] of EMA

As liver function may change during treatment with Victrelis, a close monitoring of International Normalised Ratio (INR) values is recommended in patients treated with vitamin K antagonists.

 

Boceprevir [1], voriconazole ---> SmPC of [1] of EMA

The inhibition of CYP3A4 and P-glycoprotein may increase the plasma concentrations of boceprevir. Caution should be exercised when boceprevir is combined with azole antifungals

 

Boceprevir [1], women of childbearing potential ---> SmPC of [1] of EMA

Therefore, female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.

 

Boceprevir, bosutinib [2] ---> SmPC of [2] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Boceprevir, cariprazine [2] ---> SmPC of [2] of EMA

Metabolism of cariprazine and its major active metabolites is mediated mainly by CYP3A4. The co-administration of cariprazine with strong or moderate inhibitors of CYP3A4 is contraindicated

 

Boceprevir, cobicistat [2] ---> SmPC of [2] of EMA

Co-administration of cobicistat with medicinal products that are moderate inducers of CYP3A may result in decreased plasma concentration of cobicistat. Concomitant use not recommended

 

Boceprevir, dabigatran [2] ---> SmPC of [2] of EMA

An increase in plasma concentrations of substrates of the P-gp efflux transporter, such as digoxin or dabigatran, should be anticipated (see table 2).

 

Boceprevir, daclatasvir [2] ---> SmPC of [2] of EMA

Strong inhibitors of CYP3A4 may increase the plasma levels of daclatasvir. Dose adjustment of daclatasvir is recommended when coadministered with strong inhibitors of CYP3A4

 

Boceprevir, darunavir/cobicistat ---> SmPC of [darunavir] of EMA

Concomitant use of darunavir/cobicistat with weak to moderate CYP3A4 inductors may result in subtherapeutic plasma exposure to darunavir. Co-administration of darunavir/cobicistat with weak to moderate CYP3A inducers is not recommended

 

Boceprevir, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

This antiviral may decrease darunavir and/or cobicistat plasma levels and adversely affect the intracellular activation and clinical antiviral efficacy of tenofovir alafenamide. Symtuza may decrease this antiviral plasma concentration.

 

Boceprevir, darunavir/ritonavir ---> SmPC of [darunavir] of EMA

It is not recommended to co-administer boosted darunavir and boceprevir.

 

Boceprevir, dolutegravir [2] ---> SmPC of [2] of EMA

No dosage adjustment necessary.

 

Boceprevir, dolutegravir/abacavir/lamivudine [2] ---> SmPC of [2] of EMA

No dosage adjustment necessary.

 

Boceprevir, dolutegravir/lamivudine [2] ---> SmPC of [2] of EMA

No dose adjustment is necessary.

 

Boceprevir, dolutegravir/rilpivirine [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

 

Boceprevir, eliglustat [2] ---> SmPC of [2] of EMA

Increased eliglustat exposition would be expected for strong inhibitors of CYP3A. Caution should be used with strong CYP3A inhibitors in intermediate and extensive metabolisers.

 

Boceprevir, eltrombopag [2] ---> SmPC of [2] of EMA

Co-administration of a single dose of eltrombopag with boceprevir increased Cmax by 20 %, and decreased Cmin by 32 %. Increased clinical and laboratory monitoring for HCV suppression is recommended.

 

Boceprevir, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration with boceprevir has the potential to adversely affect the intracellular activation and clinical antiviral efficacy of tenofovir alafenamide, therefore co-administration of Genvoya and boceprevir is not recommended.

 

Boceprevir, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Co-administration of boceprevir with elvitegravir/cobicistat/emtricitabine/tenofovir is not recommended.

 

Boceprevir, emtricitabine/rilpivirine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration is not recommended. Boceprevir or telaprevir have the potential to adversely affect the intracellular activation and clinical antiviral efficacy of tenofovir alafenamide based on in vitro data.

 

Boceprevir, emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration with boceprevir or telaprevir has the potential to adversely affect the intracellular activation and clinical antiviral efficacy of tenofovir alafenamide, therefore co-administration is not recommended.

 

Boceprevir, enfortumab vedotin [2] ---> SmPC of [2] of EMA

Patients receiving concomitant strong CYP3A4 inhibitors should be monitored more closely for signs of toxicities.

 

Boceprevir, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA

Co-administration of fosamprenavir with ritonavir and the HCV protease inhibitor boceprevir may lead to subtherapeutic levels of both, fosamprenavir and boceprevir. Thus, co-administration is not recommended

 

Boceprevir, fostamatinib [2] ---> SmPC of [2] of EMA

Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.

 

Boceprevir, ganciclovir ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

 

Boceprevir, glasdegib [2] ---> SmPC of [2] of EMA

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

 

Boceprevir, guanfacin [2] ---> SmPC of [2] of EMA

Co-administration of Intuniv with moderate and strong CYP3A4/5 inhibitors elevates plasma guanfacine concentrations and increases the risk of adverse reactions such as hypotension, bradycardia, and sedation.

 

Boceprevir, idelalisib [2] ---> SmPC of [2] of EMA

The co-administration of idelalisib with boceprevir may increase the serum concentrations of boceprevir. Clinical monitoring is recommended.

 

Boceprevir, imatinib [2] ---> SmPC of [2] of EMA

Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity could decrease metabolism and increase imatinib concentrations. Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.

 

Boceprevir, lorlatinib [2] ---> SmPC of [2] of EMA

CYP3A4/5 inhibitors may increase lorlatinib plasma concentrations and should be avoided

 

Boceprevir, lurasidone [2] ---> SmPC of [2] of EMA

Lurasidone and its active metabolite ID-14283 are primarily metabolised by CYP3A4. Lurasidone is contraindicated with strong CYP3A4 inhibitors

 

Boceprevir, maraviroc [2] ---> SmPC of [2] of EMA

Boceprevir concentrations are not likely to be affected by maraviroc co-administration

 

Boceprevir, methotrexate

The inhibition of the transporters of the P-glycoprotein and breast cancer resistant protein (BCRP) may increase the plasma concentrations of boceprevir.

 

Boceprevir, nevirapine [2] ---> SmPC of [2] of EMA

It is not recommended to co-administer boceprevir and nevirapine

 

Boceprevir, olaparib [2] ---> SmPC of [2] of EMA

Known strong or moderate CYP3A inhibitors are not recommended with olaparib

 

Boceprevir, pazopanib

The inhibition of the transporters of the P-glycoprotein and breast cancer resistant protein (BCRP) may increase the plasma concentrations of boceprevir.

 

Boceprevir, polatuzumab vedotin [2] ---> SmPC of [2] of EMA

Patients receiving concomitant strong CYP3A4 inhibitors should be monitored more closely for signs of toxicities.

 

Boceprevir, rivaroxaban

The inhibition of the transporters of the P-glycoprotein and breast cancer resistant protein (BCRP) may increase the plasma concentrations of boceprevir.

 

Boceprevir, ruxolitinib [2] ---> SmPC of [2] of EMA

When administering ruxolitinib with strong CYP3A4 inhibitors the unit dose of ruxolitinib should be reduced by approximately 50%, to be administered twice daily.

 

Boceprevir, simeprevir [2] ---> SmPC of [2] of EMA

The HCV protease inhibitor is anticipated to be cross-resistant, and co-administration with simeprevir is not recommended

 

Boceprevir, sirolimus [2] ---> SmPC of [2] of EMA

The CYP3A4 inhibition by boceprevir increases the sirolimus plasma levels. The combination requires significant dose reduction and prolongation of the dosing interval for tacrolimus

 

Boceprevir, sofosbuvir [2] ---> SmPC of [2] of EMA

No drug-drug interaction data exists regarding the co-administration of Sovaldi with boceprevir or telaprevir.

 

Boceprevir, tadalafil

Possible decreased tadalafil metabolism

 

Boceprevir, tipranavir/ritonavir ---> SmPC of [tipranavir] of EMA

In a pharmacokinetic study of healthy volunteers, boceprevir decreased the exposure of ritonavir. Coadministration of boceprevir with tipranavir/ritonavir is not recommended

 

Boceprevir, topotecan

The inhibition of the transporters of the P-glycoprotein and breast cancer resistant protein (BCRP) may increase the plasma concentrations of boceprevir.

 

Boceprevir, valganciclovir [2] ---> SmPC of [2] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

 

Boceprevir, vorapaxar [2] ---> SmPC of [2] of EMA

Co-administration of ketoconazole with vorapaxar significantly increased the vorapaxar exposition. Concomitant use of vorapaxar with strong inhibitors of CYP3A should be avoided.

 

Boceprevir/peginterferon alfa/ribavirin, dihydroergotamine ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, ergonovine ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, ergot derivatives ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, ergotamine ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, halofantrine ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, lovastatine ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, lumefantrine ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, methylergonovine ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, midazolam ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, quetiapine ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, silodosin ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, simvastatine ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, triazolam ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

Boceprevir/peginterferon alfa/ribavirin, tyrosine kinase inhibitors ---> SmPC of [boceprevir] of EMA

Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events

 

 

             CONTRAINDICATIONS of Boceprevir (Victrelis)

             - Hypersensitivity to the active substance or any of the excipients listed in section 6.1.            

             - Patients with autoimmune hepatitis.  

             - Co-administration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as orally administered midazolam and triazolam, bepridil, pimozide, lurasidone, lumefantrine, halofantrine, tyrosine kinase inhibitors, simvastatin, lovastatin, quetiapine, alfuzosin, silodosin and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine)

             - Pregnancy    

 

             Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional information.

               

https://www.ema.europa.eu/en/documents/product-information/victrelis-epar-product-information_en.pdf  31/07/2018

 

 



 

Bortezomib (Velcade)

Ability to drive, bortezomib [2] ---> SmPC of [2] of EMA

VELCADE may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.

 

Bortezomib [1], breast-feeding ---> SmPC of [1] of EMA

It is not known whether bortezomib is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment

 

Bortezomib [1], carbamazepine ---> SmPC of [1] of EMA

The concomitant use of bortezomib with strong CYP3A4 inducers is not recommended, as efficacy may be reduced.

 

Bortezomib [1], dexamethasone ---> SmPC of [1] of EMA

In the same drug-drug interaction study assessing the effect of dexamethasone, a weaker CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib

 

Bortezomib [1], drugs primarily metabolised by CYP2D6 ---> SmPC of [1] of EMA

Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.

 

Bortezomib [1], fertility ---> SmPC of [1] of EMA

Fertility studies were not conducted with VELCADE (see section 5.3).

 

Bortezomib [1], ketoconazole ---> SmPC of [1] of EMA

The strong CYP3A4 inhibition may increase the AUC of bortezomib. Patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors

 

Bortezomib [1], melphalan/prednisone ---> SmPC of [1] of EMA

A drug-drug interaction study assessing the effect of melphalan-prednisone on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 17% based on data from 21 patients. This is not considered clinically relevant

 

Bortezomib [1], men ---> SmPC of [1] of EMA

Male patients should use effective contraceptive measures and be advised not to father a child while receiving VELCADE and for 5 months following completion of treatment (see section 5.3).

 

Bortezomib [1], omeprazole ---> SmPC of [1] of EMA

In a drug-drug interaction study assessing the effect of omeprazole, a potent CYP2C19 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib

 

Bortezomib [1], oral antidiabetics ---> SmPC of [1] of EMA

Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.

 

Bortezomib [1], peripheral neuropathy ---> SmPC of [1] of EMA

Treatment with bortezomib is very commonly associated with peripheral neuropathy, which is predominantly sensory.

 

Bortezomib [1], phenobarbital ---> SmPC of [1] of EMA

The concomitant use of bortezomib with strong CYP3A4 inducers is not recommended, as efficacy may be reduced.

 

Bortezomib [1], phenytoin ---> SmPC of [1] of EMA

The concomitant use of bortezomib with strong CYP3A4 inducers is not recommended, as efficacy may be reduced.

 

Bortezomib [1], pregnancy ---> SmPC of [1] of EMA

VELCADE should not be used during pregnancy unless the clinical condition of the woman requires treatment with VELCADE.

 

Bortezomib [1], pregnancy ---> SmPC of [1] of EMA

If VELCADE is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.

 

Bortezomib [1], rifampicin ---> SmPC of [1] of EMA

The concomitant use of bortezomib with strong CYP3A4 inducers is not recommended, as efficacy may be reduced.

 

Bortezomib [1], ritonavir ---> SmPC of [1] of EMA

The strong CYP3A4 inhibition may increase the AUC of bortezomib. Patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors

 

Bortezomib [1], St. John's wort ---> SmPC of [1] of EMA

The concomitant use of bortezomib with strong CYP3A4 inducers is not recommended, as efficacy may be reduced.

 

Bortezomib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

The concomitant use of bortezomib with strong CYP3A4 inducers is not recommended, as efficacy may be reduced.

 

Bortezomib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

The strong CYP3A4 inhibition may increase the AUC of bortezomib. Patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors

 

Bortezomib [1], thalidomide ---> SmPC of [1] of EMA

Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.

 

Bortezomib [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential must use effective contraceptive measures and avoid becoming pregnant while being treated with VELCADE and for 8 months following completion of treatment.

 

Bortezomib, daratumumab [2] ---> SmPC of [2] of EMA

Clinical pharmacokinetic assessments of daratumumab in combination with lenalidomide, pomalidomide, thalidomide, bortezomib and dexamethasone indicated no clinically-relevant drug-drug interaction

 

Bortezomib, EGFR inhibitors ---> SmPC of [erlotinib] of EMA

Due to the working mechanism, proteasome inhibitors may be expected to influence the effect of EGFR inhibitors

 

Bortezomib, erlotinib [2] ---> SmPC of [2] of EMA

Due to the working mechanism, proteasome inhibitors including bortezomib may be expected to influence the effect of EGFR inhibitors including erlotinib.

 

Bortezomib, imatinib [2] ---> SmPC of [2] of EMA

Imatinib inhibits CYP3A4 and may increase plasma concentration of other CYP3A4 metabolised drugs. Caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window

 

Bortezomib, ketoconazole [2] ---> SmPC of [2] of EMA

Careful monitoring. Dose adjustment of each medicinal product may be required.

 

Bortezomib, thalidomide [2] ---> SmPC of [2] of EMA

Medicinal products known to be associated with peripheral neuropathy (e.g. vincristine and bortezomib) should be used with caution in patients receiving thalidomide.

 

Bortezomib, vandetanib

Vandetanib, CYP3A4 inductor, may decrease the plasma levels of bortezomib. Caution should be exercised

 

 

            CONTRAINDICATIONS of Bortezomib (Velcade)

            - Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.

            - Acute diffuse infiltrative pulmonary and pericardial disease.

            - When VELCADE is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.

 

            https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf 24/10/2024

 

Other trade names: Bortezomib Accord, Bortezomib Fresenius Kabi, Bortezomib Hospira, Bortezomib Sun,

 






Bosentan (Tracleer)

Ability to drive, bosentan [2] ---> SmPC of [2] of EMA

Tracleer may induce hypotension, with symptoms of dizziness, blurred vision or syncope that could affect the ability to drive or use machines.

 

Antiretrovirals, bosentan [2] ---> SmPC of [2] of EMA

Due to the potential for interactions related to the inducing effect of bosentan on CYP450, which could affect the efficacy of antiretroviral therapy, these patients should also be monitored carefully regarding their HIV infection.

 

Atazanavir, bosentan

Bosentan is metabolised by CYP2C9 and CYP3A4. Inhibition of these isoenzymes may increase the plasma concentration of bosentan. The combination should be used with caution.

 

Atazanavir/cobicistat [1], bosentan ---> SmPC of [1] of EMA

Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect

 

Avacopan [1], bosentan ---> SmPC of [1] of EMA

Exercise caution when using moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, and modafinil) prescribed as concomitant medicinal product with avacopan and carefully evaluate the benefit/risk of avacopan.

 

Avanafil [1], bosentan ---> SmPC of [1] of EMA

The potential effect of CYP inducers, especially inducers of CYP3A4 on the pharmacokinetics and efficacy of avanafil has not been evaluated. The concomitant use of avanafil and a CYP inducer is not recommended as it may decrease the efficacy of avanafil.

 

Avapritinib [1], bosentan ---> SmPC of [1] of EMA

Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib

 

Bempedoic acid [1], bosentan ---> SmPC of [1] of EMA

Coadministration of bempedoic acid with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bempedoic acid/ezetimibe [1], bosentan ---> SmPC of [1] of EMA

Coadministration of Nustendi with medicinal products that are substrates of OATP1B1 or OATP1B3 may result in increased plasma concentrations of these medicinal products.

 

Bosentan [1], breast-feeding ---> SmPC of [1] of EMA

It is not known whether bosentan is excreted into human breast milk. Breast-feeding is not recommended during treatment with Tracleer.

 

Bosentan [1], carbamazepine ---> SmPC of [1] of EMA

Concomitant administration of bosentan and CYP3A4 inductors is expected to lead to reduced systemic exposure to bosentan. A clinically significant reduction of efficacy cannot be excluded.

 

Bosentan [1], cyclosporine ---> SmPC of [1] of EMA

Co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).

 

Bosentan [1], CYP2C9 and CYP3A4 inhibitors ---> SmPC of [1] of EMA

Bosentan is metabolised by CYP2C9 and CYP3A4. Inhibition of these isoenzymes may increase the plasma concentration of bosentan. The combination should be used with caution.

 

Bosentan [1], digoxin ---> SmPC of [1] of EMA

Co-administration of bosentan with digoxin decreased the AUC, Cmax and Cmin of digoxin. The mechanism for this interaction may be induction of P-glycoprotein. This interaction is unlikely to be of clinical relevance.

 

Bosentan [1], drugs metabolised by CYP3A4 and CYP2C9 ---> SmPC of [1] of EMA

Bosentan is an inducer of the cytochrome P450 (CYP)isoenzymes CYP2C9 and CYP3A4. Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when bosentan is co-administered.

 

Bosentan [1], epoprostenol ---> SmPC of [1] of EMA

After both single- and multiple-dose administration, the Cmax and AUC values of bosentan were similar in patients with or without continuous infusion of epoprostenol

 

Bosentan [1], ethinyl estradiol ---> SmPC of [1] of EMA

Decreased exposition to ethinyl estradiol

 

Bosentan [1], fertility ---> SmPC of [1] of EMA

It cannot be excluded that bosentan may have a detrimental effect on spermatogenesis in men. In male children, a long-term impact on fertility after treatment with bosentan cannot be excluded.

 

Bosentan [1], fluconazole ---> SmPC of [1] of EMA

Co-administration with fluconazole, which inhibits mainly CYP2C9, but to some extent also CYP3A4, could lead to large increases in plasma concentrations of bosentan. The combination is not recommended.

 

Bosentan [1], glibenclamide ---> SmPC of [1] of EMA

Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of glibenclamide (a CYP3A4 substrate) by 40%, with potential significant decrease of the hypoglycaemic effect.

 

Bosentan [1], glibenclamide ---> SmPC of [1] of EMA

Both glibenclamide and bosentan inhibit the bile salt export pump, which could explain the elevated aminotransferases. This combination should not be used.

 

Bosentan [1], itraconazol ---> SmPC of [1] of EMA

For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with Tracleer is not recommended.

 

Bosentan [1], ketoconazole ---> SmPC of [1] of EMA

For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with Tracleer is not recommended.

 

Bosentan [1], nevirapine ---> SmPC of [1] of EMA

Due to the marked hepatotoxicity of nevirapine, which could add to bosentan liver toxicity, this combination is not recommended

 

Bosentan [1], norethisterone ---> SmPC of [1] of EMA

Decreased exposition to norethisterone

 

Bosentan [1], oral contraceptives ---> SmPC of [1] of EMA

Hormone-based contraceptives alone, regardless of the route of administration (i.e., oral, injectable, transdermal or implantable forms), are not considered as reliable methods of contraception

 

Bosentan [1], phenobarbital ---> SmPC of [1] of EMA

Concomitant administration of bosentan and CYP3A4 inductors is expected to lead to reduced systemic exposure to bosentan. A clinically significant reduction of efficacy cannot be excluded.

 

Bosentan [1], phenytoin ---> SmPC of [1] of EMA

Concomitant administration of bosentan and CYP3A4 inductors is expected to lead to reduced systemic exposure to bosentan. A clinically significant reduction of efficacy cannot be excluded.

 

Bosentan [1], pregnancy ---> SmPC of [1] of EMA

Tracleer is contraindicated in pregnancy

 

Bosentan [1], rifampicin ---> SmPC of [1] of EMA

The strong CYP2C9 and CYP3A4 induction decreases the plasma concentrations of bosentan. The combination is not recommended

 

Bosentan [1], ritonavir ---> SmPC of [1] of EMA

For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with Tracleer is not recommended.

 

Bosentan [1], simvastatine ---> SmPC of [1] of EMA

Co-administration of bosentan decreased the plasma concentrations of simvastatin (a CYP3A4 substrate) and its active beta-hydroxy acid metabolite

 

Bosentan [1], sirolimus ---> SmPC of [1] of EMA

The co-administration may increase the bosentan plasma concentrations and decrease the levels of sirolimus. The coadministration is not recommended

 

Bosentan [1], St. John's wort ---> SmPC of [1] of EMA

Concomitant administration of bosentan and CYP3A4 inductors is expected to lead to reduced systemic exposure to bosentan. A clinically significant reduction of efficacy cannot be excluded.

 

Bosentan [1], strong CYP2C9 inhibitors ---> SmPC of [1] of EMA

The influence of CYP2C9 inhibitors on bosentan concentration has not been studied. The combination should be used with caution.

 

Bosentan [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

Concomitant administration of bosentan and CYP3A4 inductors is expected to lead to reduced systemic exposure to bosentan. A clinically significant reduction of efficacy cannot be excluded.

 

Bosentan [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

The strong CYP3A4 inhibition may increase the plasma concentrations of bosentan. Co-administration is not recommended

 

Bosentan [1], tacrolimus ---> SmPC of [1] of EMA

The co-administration may increase the bosentan plasma concentrations and decrease the levels of tacrolimus. The coadministration is not recommended

 

Bosentan [1], tadalafil ---> SmPC of [1] of EMA

Bosentan (125 mg twice daily) reduced tadalafil (40 mg once per day) systemic exposure by 42% and Cmax by 27% following multiple dose co-administration. Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites.

 

Bosentan [1], voriconazole ---> SmPC of [1] of EMA

Bosentan is metabolised by CYP2C9 and CYP3A4. Inhibition of these isoenzymes may increase the plasma concentration of bosentan. The combination should be used with caution.

 

Bosentan [1], warfarin ---> SmPC of [1] of EMA

No dose adjustment is needed for warfarin and similar oral anticoagulant agents when bosentan is initiated, but intensified monitoring of INR is recommended, especially during bosentan initiation and the up-titration period.

 

Bosentan [1], women of childbearing potential ---> SmPC of [1] of EMA

Before the initiation of Tracleer treatment in women of childbearing potential, the absence of pregnancy should be checked, appropriate advice on reliable methods of contraception provided, and reliable contraception initiated.

 

Bosentan [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential must not use hormonal contraceptives (including oral, injectable, transdermal or implantable forms) as the sole method of contraception but must use an additional or an alternative reliable method of contraception.

 

Bosentan, bosutinib [2] ---> SmPC of [2] of EMA

The concomitant use of bosutinib with moderate CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosentan, brigatinib [2] ---> SmPC of [2] of EMA

The concomitant use of moderate CYP3A inducers with Alunbrig, including but not limited to efavirenz, modafinil, bosentan, etravirine, and nafcillin should be avoided.

 

Bosentan, bulevirtide [2] ---> SmPC of [2] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bosentan, capivasertib [2] ---> SmPC of [2] of EMA

Co-administration of capivasertib with moderate CYP3A4 inducer has the potential to decrease the concentration of capivasertib. This may reduce the efficacy of TRUQAP. Co-administration of moderate CYP3A4 inducers should be avoided

 

Bosentan, cariprazine [2] ---> SmPC of [2] of EMA

The co-administration of cariprazine and strong or moderate CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort (Hypericum perforatum), bosentan, efavirenz, etravirine, modafinil, nafcillin) is contraindicated

 

Bosentan, cobicistat [2] ---> SmPC of [2] of EMA

Co-administration of cobicistat with medicines that are moderate to weak inducers of CYP3A may result in decreased cobicistat plasma level and that of atazanavir/darunavir being boosted, leading to loss of therapeutic effect

 

Bosentan, darunavir/cobicistat ---> SmPC of [darunavir] of EMA

Co-administration of darunavir/cobicistat with weak to moderate CYP3A inducers (e.g. efavirenz, etravirine, nevirapine, fluticasone, and bosentan) is not recommended (see interaction table below).

 

Bosentan, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Based on theoretical considerations bosentan is expected to decrease darunavir and/or cobicistat plasma concentrations. CYP3A induction. Symtuza is expected to increase bosentan plasma concentrations. CYP3A inhibition

 

Bosentan, darunavir/ritonavir ---> SmPC of [darunavir] of EMA

Concomitant use of bosentan and boosted darunavir may increase plasma concentrations of bosentan. Bosentan is expected to decrease plasma concentrations of darunavir and/or its pharmacoenhancer. (CYP3A induction)

 

Bosentan, doravirine [2] ---> SmPC of [2] of EMA

If co-administration with other moderate CYP3A inducers cannot be avoided, the doravirine dose should be increased to 100 mg twice daily (the doses should be taken approximately 12 hours apart)

 

Bosentan, doravirine/lamivudine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

If co-administration with other moderate CYP3A inducers cannot be avoided, the doravirine dose should be increased to 100 mg twice daily (the doses should be taken approximately 12 hours apart)

 

Bosentan, drospirenone/estetrol [2] ---> SmPC of [2] of EMA

Medicinal products increasing the clearance of CHCs

 

Bosentan, duvelisib [2] ---> SmPC of [2] of EMA

Co-administration of duvelisib with moderate CYP3A inducers decreases AUC of duvelisib to less than 1.5-fold and dose reduction is not recommended. The patient should be closely monitored for potential lack of efficacy.

 

Bosentan, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

 

Bosentan, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

CYP3A or P-gp induction. Co-administration is contraindicated.

 

Bosentan, elvitegravir [2] ---> SmPC of [2] of EMA

Co-administration of elvitegravir with medicines that are moderate inducers of CYP3A is not recommended as the expected decrease in elvitegravir plasma levels can lead to loss of therapeutic effect and possible development of resistance to elvitegravir

 

Bosentan, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration with Genvoya may lead to decreased elvitegravir and/or cobicistat exposures and loss of therapeutic effect and development of resistance. Alternative endothelin receptor antagonists may be considered.

 

Bosentan, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Co-administration with Stribild may lead to decreased elvitegravir and/or cobicistat exposures and loss of therapeutic effect and development of resistance.

 

Bosentan, encorafenib [2] ---> SmPC of [2] of EMA

Agents that are substrates of the hepatic transporters OATP1B1, OATP1B3, OCT1 (such as atorvastatin, bosentan) may have increased exposure and should be therefore co-administered with caution.

 

Bosentan, entrectinib [2] ---> SmPC of [2] of EMA

Caution is advised when sensitive oral OATP1B1 substrates (e.g. atorvastatin, pravastatin, rosuvastatin repaglinide, bosentan) are co-administered with entrectinib, due to the risk of increased absorption.

 

Bosentan, erdafitinib [2] ---> SmPC of [2] of EMA

If Balversa is co-administered with a moderate CYP3A4 inducer the dose should be cautiously increased by 1 to 2 mg and adjusted gradually every two to three weeks based on clinical monitoring for adverse reactions, not to exceed 9 mg.

 

Bosentan, ethinylestradiol/desogestrel

Interactions can occur with drugs that induce microsomal enzymes, which can result in increased clearance of sex hormones

 

Bosentan, ethinylestradiol/drospirenone [2] ---> SmPC of [2] of eMC

Interactions can occur with drugs that induce hepatic enzymes which can result in increased clearance of sex hormones

 

Bosentan, ethinylestradiol/norgestimate [2] ---> SmPC of [2] of eMC

Drugs or herbal products that induce enzymes, especially CYP3A4, may decrease the plasma concentrations of contraceptive hormones, and may decrease their effectiveness and/or increase breakthrough bleeding.

 

Bosentan, etonogestrel

Interactions can occur with medicinal products that induce microsomal enzymes, specifically cytochrome P450 enzymes, which can result in increased clearance of sex hormones

 

Bosentan, glasdegib [2] ---> SmPC of [2] of EMA

Concomitant use of Daurismo with moderate CYP3A4 inducers should be avoided. If concomitant use of moderate CYP3A4 inducers cannot be avoided, the dose of Daurismo should be increased as tolerated

 

Bosentan, guanfacin [2] ---> SmPC of [2] of EMA

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

 

Bosentan, idelalisib [2] ---> SmPC of [2] of EMA

The co-administration of idelalisib with bosentan may increase the serum concentrations of bosentan. Caution should be exercised and patients closely observed for bosentan-related toxicity.

 

Bosentan, ketoconazole [2] ---> SmPC of [2] of EMA

Not recommended due to the potential for hepatic toxicity (see section 4.3).

 

Bosentan, lefamulin [2] ---> SmPC of [2] of EMA

Medicinal products that are moderate/strong CYP3A inducers could significantly decrease lefamulin plasma concentration and may lead to reduced therapeutic effect of lefamulin. Co-administration of such medicinal products with lefamulin is contraindicated

 

Bosentan, letermovir [2] ---> SmPC of [2] of EMA

Bosentan may decrease plasma concentrations of letermovir. Co-administration of PREVYMIS and bosentan is not recommended.

 

Bosentan, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA

Bosentan (induction) may decrease the plasma levels of lopinavir/ritonavir. Ritonavir (inhibition) may increase the levels of bosentan. Caution should be exercised

 

Bosentan, lurasidone [2] ---> SmPC of [2] of EMA

Coadministration of lurasidone with moderate inducers of CYP3A4 would be expected to give a <2-fold reduction in lurasidone exposure during co-administration and for up to 2 weeks after discontinuation of mild or moderate CYP3A4 inducers.

 

Bosentan, medroxyprogesterone

The co-administration decreases the plasma levels of medroxyprogesterone

 

Bosentan, miconazole

Bosentan is metabolised by CYP2C9 and CYP3A4. Inhibition of these isoenzymes may increase the plasma concentration of bosentan. The combination should be used with caution.

 

Bosentan, nelfinavir [2] ---> SmPC of [2] of EMA

Concomitant use of bosentan and nelfinavir may increase plasma levels of bosentan. When administered concomitantly with nelfinavir, the patient's tolerability of bosentan should be monitored.

 

Bosentan, neratinib [2] ---> SmPC of [2] of EMA

Concurrent use of neratinib with moderate CYP3A4/P-gp inducers is not recommended as it may also lead to loss of efficacy

 

Bosentan, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA

Coadministration of bosentan and ritonavir may increase steady-state bosentan maximum concentrations (Cmax) and AUC.

 

Bosentan, nomegestrol/estradiol [2] ---> SmPC of [2] of EMA

Interactions can occur with substances that induce CYP450 enzymes, resulting in reduced concentrations of sex hormones and decreased effectiveness of combined oral contraceptives, including Zoely.

 

Bosentan, norelgestromin/ethinylestradiol [2] ---> SmPC of [2] of EMA

Interactions can occur with medicinal products that induce hepatic enzymes which can result in increased clearance of sex hormones

 

Bosentan, olaparib [2] ---> SmPC of [2] of EMA

Olaparib is an inhibitor of OATP1B1. It cannot be excluded that olaparib may increase the exposure to substrates of OATP1B1

 

Bosentan, osimertinib [2] ---> SmPC of [2] of EMA

Moderate CYP3A4 inducers (e g bosentan, efavirenz, etravirine, modafinil) may also decrease osimertinib exposure and should be used with caution, or avoided when possible.

 

Bosentan, padeliporfin [2] ---> SmPC of [2] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

 

Bosentan, quizartinib [2] ---> SmPC of [2] of EMA

Decreased quizartinib exposure may lead to reduced efficacy. Co-administration of VANFLYTA with strong or moderate CYP3A inducers should be avoided.

 

Bosentan, rimegepant [2] ---> SmPC of [2] of EMA

Inducers of CYP3A4 decrease plasma concentrations of rimegepant. Concomitant administration of VYDURA with moderate CYP3A4 inducers (e.g., bosentan, efavirenz, modafinil) is not recommended

 

Bosentan, riociguat [2] ---> SmPC of [2] of EMA

Bosentan, reported to be a moderate inducer of CYP3A4, led to a decrease of riociguat steady-state plasma concentrations in PAH patients by 27%

 

Bosentan, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA

The plasma concentrations of bosentan may increase und the plasma concentrations of saquinavir/ritonavir may decrease

 

Bosentan, sildenafil [2] ---> SmPC of [2] of EMA

Co-administration during 6 days in healthy volunteers resulted in a 63% decrease in the sildenafil AUC and a 50% increase in the bosentan AUC. Caution is recommended in the case of co-administration.

 

Bosentan, sotagliflozin [2] ---> SmPC of [2] of EMA

It cannot be ruled out that sotagliflozin may interact with other sensitive OAT3, OATP- and/or BCRP- substrates resulting in potentially larger increases of exposure than seen for rosuvastatin.

 

Bosentan, sparsentan [2] ---> SmPC of [2] of EMA

Concomitant use of sparsentan with ERAs such as bosentan, ambrisentan, macitentan, sitaxentan, ARBs such as irbesartan, losartan, valsartan, candesartan, telmisartan, or renin inhibitors such as aliskiren is contraindicated (see section 4.3).

 

Bosentan, telaprevir [2] ---> SmPC of [2] of EMA

Concomitant administration of INCIVO and drugs transported by these transporters such as fluvastatin, pravastatin, rosuvastatin, pitavastatin, bosentan and repaglinide should be undertaken with caution (see table 2).

 

Bosentan, tipranavir/ritonavir ---> SmPC of [tipranavir] of EMA

Due to the marked hepatotoxicity of bosentan and the potential for increasing the liver toxicity associated with tipranavir, co-administered with low dose ritonavir, this combination is not recommended.

 

Bosentan, treprostinil [2] ---> SmPC of [2] of EMA

In a pharmacokinetic study in humans, in which bosentan (250 mg/day) and treprostinil diolamine (oral dose of 2 mg/day) were administered concomitantly, no pharmacokinetic interaction between treprostinil and bosentan was observed.

 

Bosentan, venetoclax [2] ---> SmPC of [2] of EMA

Concomitant use of venetoclax with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampicin) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided.

 

Bosentan, vismodegib [2] ---> SmPC of [2] of EMA

In vitro, vismodegib is an inhibitor of OATP1B1. It cannot be excluded that vismodegib may increase the exposure to substrates of OATP1B1. In particular, caution should be exercised if vismodegib is administered in combination with any statin.

 

Bosentan, zanubrutinib [2] ---> SmPC of [2] of EMA

Concomitant use with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort) and moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided

 

Digoxin, P-gp inductors ---> SmPC of [bosentan] of EMA

The induction of P-glycoprotein reduces the exposition of digoxin

 

 

            CONTRAINDICATIONS of Bosentan (Tracleer)

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C

            - Baseline values of liver aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT), greater than 3 times the upper limit of normal

            - Concomitant use of cyclosporine A

            - Pregnancy

            - Women of child-bearing potential who are not using reliable methods of contraception

 

            https://www.ema.europa.eu/en/documents/product-information/tracleer-epar-product-information_en.pdf 25/10/2024

 

Other trade names: Stayveer,

 





Bosutinib (Bosulif)

Ability to drive, bosutinib [2] ---> SmPC of [2] of EMA

Dizziness, fatigue and visual impairment or other undesirable effects with a potential impact on the ability to drive or use machines safely may occur

 

ACE inhibitors, bosutinib [2] ---> SmPC of [2] of EMA

It is important that renal function is assessed prior to treatment initiation and closely monitored during therapy, with particular attention to patients who have pre-existing renal compromise/to patients exhibiting risk factors for renal dysfunction

 

AIIRA, bosutinib [2] ---> SmPC of [2] of EMA

It is important that renal function is assessed prior to treatment initiation and closely monitored during therapy, with particular attention to patients who have pre-existing renal compromise/to patients exhibiting risk factors for renal dysfunction

 

Alternative medicine, bosutinib [2] ---> SmPC of [2] of EMA

Selection of an alternate concomitant medicinal product with no or minimal CYP3A inhibition potential, if possible, is recommended.

 

Amiodarone, bosutinib [2] ---> SmPC of [2] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Amprenavir, bosutinib [2] ---> SmPC of [2] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Antacids, bosutinib [2] ---> SmPC of [2] of EMA

Short-acting antacids should be considered as an alternative to PPIs and administration times of bosutinib and antacids should be separated (i.e. take bosutinib in the morning and antacids in the evening) whenever possible.

 

Aprepitant, bosutinib [2] ---> SmPC of [2] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Atazanavir, bosutinib [2] ---> SmPC of [2] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

BCRP substrates, bosutinib [2] ---> SmPC of [2] of EMA

Bosutinib may have the potential to inhibit BCRP in the gastrointestinal tract and OCT1.

 

Boceprevir, bosutinib [2] ---> SmPC of [2] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosentan, bosutinib [2] ---> SmPC of [2] of EMA

The concomitant use of bosutinib with moderate CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], breast-feeding ---> SmPC of [1] of EMA

A potential risk to the breast-feeding infant cannot be excluded. Breast-feeding should be discontinued during treatment with bosutinib.

 

Bosutinib [1], carbamazepine ---> SmPC of [1] of EMA

The concomitant use of bosutinib with strong CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], chloroquine ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], ciprofloxacin ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], clarithromycin ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], class IA antiarrhythmic agents ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], class III antiarrhythmic agents ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], conivaptan ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], crizotinib ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], CYP2B6 substrates ---> SmPC of [1] of EMA

An in vitro study indicates that drug-drug interactions are unlikely to occur at therapeutic doses as a result of induction by bosutinib on the metabolism of medicinal products that are substrates for CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4.

 

Bosutinib [1], CYP3A4 inductors ---> SmPC of [1] of EMA

Caution should be exercised if mild CYP3A inductors are used concomitantly with bosutinib.

 

Bosutinib [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA

Caution should be exercised if mild CYP3A inhibitors are used concomitantly with bosutinib. Selection of an alternate concomitant medicinal product with no or minimal CYP3A enzyme inhibition potential, if possible, is recommended.

 

Bosutinib [1], CYP3A4 substrates ---> SmPC of [1] of EMA

An in vitro study indicates that drug-drug interactions are unlikely to occur at therapeutic doses as a result of induction by bosutinib on the metabolism of medicinal products that are substrates for CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4.

 

Bosutinib [1], dabigatran ---> SmPC of [1] of EMA

Bosutinib did not increase Cmax or AUC of dabigatran in plasma, as compared with administration of dabigatran etexilate mesylate alone. The study results indicate that bosutinib does not exhibit clinically relevant P-gp inhibitory effects.

 

Bosutinib [1], darunavir ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], darunavir/ritonavir ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], diltiazem ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], disopyramide ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], diuretics ---> SmPC of [1] of EMA

It is important that renal function is assessed prior to treatment initiation and closely monitored during therapy, with particular attention to patients who have pre-existing renal compromise/to patients exhibiting risk factors for renal dysfunction

 

Bosutinib [1], domperidone ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], dronedarone ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], efavirenz ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], erythromycin ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], etravirine ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], fertility ---> SmPC of [1] of EMA

Based on non-clinical findings, bosutinib has the potential to impair reproductive function and fertility in humans (see section 5.3).

 

Bosutinib [1], fluconazole ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], foods ---> SmPC of [1] of EMA

Bosulif should be taken orally once daily with food (see section 5.2). If a dose is missed the patient should not be given an additional dose. The patient should take the usual prescribed dose on the following day.

 

Bosutinib [1], fosamprenavir ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], grapefruit ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], grapefruit juice ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], halofantrine ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], haloperidol ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], hepatotoxic drugs ---> SmPC of [1] of EMA

Patients receiving bosutinib should have liver function tests prior to treatment initiation and monthly for the first three months of treatment, and as clinically indicated.

 

Bosutinib [1], imatinib ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], indinavir ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], infection ---> SmPC of [1] of EMA

Bosutinib may predispose patients to bacterial, fungal, viral, or protozoan infections.

 

Bosutinib [1], itraconazol ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], ketoconazole ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], liquid retention ---> SmPC of [1] of EMA

Treatment with bosutinib may be associated with fluid retention including pericardial effusion, pleural effusion, pulmonary oedema and/or peripheral oedema. Patients should be monitored and managed using standard-of-care treatment.

 

Bosutinib [1], lopinavir/ritonavir ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], men ---> SmPC of [1] of EMA

Men being treated with bosutinib are advised to seek advice on conservation of sperm prior to treatment because of the possibility of decreased fertility due to therapy with bosutinib.

 

Bosutinib [1], methadone ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], mibefradil ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], modafinil ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], moxifloxacin ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], myelosuppression ---> SmPC of [1] of EMA

Treatment with bosutinib is associated with myelosuppression, defined as anaemia, neutropenia, and thrombocytopenia. Complete blood counts should be performed weekly for the first month and then monthly thereafter, or as clinically indicated.

 

Bosutinib [1], nafcillin ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], nefazodone ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], nelfinavir ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], nephrotoxic substances ---> SmPC of [1] of EMA

It is important that renal function is assessed prior to treatment initiation and closely monitored during therapy, with particular attention to patients who have pre-existing renal compromise/to patients exhibiting risk factors for renal dysfunction

 

Bosutinib [1], NSAID ---> SmPC of [1] of EMA

It is important that renal function is assessed prior to treatment initiation and closely monitored during therapy, with particular attention to patients who have pre-existing renal compromise/to patients exhibiting risk factors for renal dysfunction

 

Bosutinib [1], oral contraceptives ---> SmPC of [1] of EMA

In addition, the patient should be advised that vomiting or diarrhoea may reduce the efficacy of oral contraceptives by preventing full absorption.

 

Bosutinib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA

Bosutinib does not exhibit clinically relevant P-gp inhibitory effects.

 

Bosutinib [1], pancreatitis ---> SmPC of [1] of EMA

In case lipase elevations are accompanied by abdominal symptoms, bosutinib should be interrupted and appropriate diagnostic measures considered to exclude pancreatitis (see section 4.2).

 

Bosutinib [1], phenobarbital ---> SmPC of [1] of EMA

The concomitant use of bosutinib with strong CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], phenytoin ---> SmPC of [1] of EMA

The concomitant use of bosutinib with strong CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], photosensitivity ---> SmPC of [1] of EMA

Exposure to direct sunlight or ultraviolet (UV) radiation should be avoided or minimised due to the risk of photosensitivity associated with bosutinib treatment.

 

Bosutinib [1], posaconazole ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], pregnancy ---> SmPC of [1] of EMA

Bosulif is not recommended for use during pregnancy, or in women of childbearing potential not using contraception.

 

Bosutinib [1], pregnancy ---> SmPC of [1] of EMA

If bosutinib is used during pregnancy, or the patient becomes pregnant while taking bosutinib, she should be apprised of the potential hazard to the foetus.

 

Bosutinib [1], procainamide ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], proton pump inhibitors ---> SmPC of [1] of EMA

Caution should be exercised when administering bosutinib concomitantly with proton pump inhibitors

 

Bosutinib [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], quinidine ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], renal function ---> SmPC of [1] of EMA

In a renal impairment study, bosutinib exposures were increased in subjects with moderately and severely impaired renal function. Dose reduction is recommended for patients with moderate or severe renal impairment

 

Bosutinib [1], rifabutin ---> SmPC of [1] of EMA

The concomitant use of bosutinib with strong CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], rifampicin ---> SmPC of [1] of EMA

The concomitant use of bosutinib with strong CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], ritonavir ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], saquinavir ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], skin reaction ---> SmPC of [1] of EMA

Bosutinib can induce severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. Bosutinib should be permanently discontinued in patients who experience a severe skin reaction during treatment.

 

Bosutinib [1], sotalol ---> SmPC of [1] of EMA

Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation

 

Bosutinib [1], St. John's wort ---> SmPC of [1] of EMA

The concomitant use of bosutinib with strong CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

The concomitant use of bosutinib with strong CYP3A inductors should be avoided, as a decrease in bosutinib plasma levels will occur.

 

Bosutinib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], telaprevir ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], telithromycin ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], transaminases ---> SmPC of [1] of EMA

Treatment with bosutinib is associated with elevations in serum transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]).

 

Bosutinib [1], troleandomycin ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], tumor lysis syndrome ---> SmPC of [1] of EMA

Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of bosutinib (see section 4.8).

 

Bosutinib [1], verapamil ---> SmPC of [1] of EMA

The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], voriconazole ---> SmPC of [1] of EMA

The concomitant use of bosutinib with potent CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.

 

Bosutinib [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential should be advised to use effective contraception during treatment with bosutinib and for at least 1 month after the last dose and to avoid becoming pregnant while receiving bosutinib.

 

 

 

            CONTRAINDICATIONS of Bosutinib (Bosulif)      

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Hepatic impairment   

 

            https://www.ema.europa.eu/en/documents/product-information/bosulif-epar-product-information_en.pdf 12/01/2026







Botulinum toxin type A (Nuceiva)

Ability to drive, botulinum toxin type A [2] ---> SmPC of [2] of EMA

NUCEIVA has a minor or moderate influence on the ability to drive and use machines. There is a potential risk for asthenia, muscle weakness, dizziness and visual disturbance, which could affect driving and the operation of machinery.

 

Aminoglycoside antibiotics, botulinum toxin type A [2] ---> SmPC of [2] of EMA

Theoretically, the effect of botulinum toxin may be potentiated by aminoglycoside antibiotics, spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g. neuromuscular blocking medicinal products).

 

Botulinum toxin type A [1], breast-feeding ---> SmPC of [1] of EMA

There is no information on whether NUCEIVA is excreted in human breast milk. NUCEIVA should not be used during breast-feeding.

 

Botulinum toxin type A [1], fertility ---> SmPC of [1] of EMA

The effect of NUCEIVA on human fertility is unknown. However, another botulinum toxin type A has been shown to impair the fertility of male and female animals.

 

Botulinum toxin type A [1], muscle relaxants ---> SmPC of [1] of EMA

Theoretically, the effect of botulinum toxin may be potentiated by aminoglycoside antibiotics, spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g. neuromuscular blocking medicinal products).

 

Botulinum toxin type A [1], pregnancy ---> SmPC of [1] of EMA

NUCEIVA is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

Botulinum toxin type A [1], spectinomycin ---> SmPC of [1] of EMA

Theoretically, the effect of botulinum toxin may be potentiated by aminoglycoside antibiotics, spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g. neuromuscular blocking medicinal products).

 

Botulinus toxin [1], botulinum toxin type A ---> SmPC of [1] of EMA

Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

 

 

             CONTRAINDICATIONS of Botulinum toxin type A (Nuceiva)    

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Generalised disorders of muscle activity (e.g. myasthenia gravis or Eaton Lambert Syndrome)

             - Infection or inflammation at the proposed injection sites.

              

             https://www.ema.europa.eu/en/documents/product-information/nuceiva-epar-product-information_en.pdf 28/05/2024


            



 

Botulinum toxin type B (NeuroBloc)

Ability to drive, botulinum toxin type B [2] ---> SmPC of [2] of EMA

Neurobloc may impair the ability to drive or operate machinery in case of adverse reactions such as muscle weakness and eye disorders (blurred vision, eyelid ptosis).

 

Aminoglycosides, botulinum toxin type B [2] ---> SmPC of [2] of EMA

Co-administration of NeuroBloc and aminoglycosides or agents interfering with neuromuscular transmission (e.g. curare-like compounds) should be considered with caution.

 

Anticoagulants, botulinum toxin type B [2] ---> SmPC of [2] of EMA

Caution should be used in patients with bleeding disorders or receiving anticoagulant therapy.

 

Botulinum toxin type B [1], breast-feeding ---> SmPC of [1] of EMA

A decision must be made on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with NeuroBloc taking into account the benefit of breast-feeding to the child and the benefit of NeuroBloc therapy to the woman.

 

Botulinum toxin type B [1], curare-type muscle relaxants ---> SmPC of [1] of EMA

Co-administration of NeuroBloc and aminoglycosides or agents interfering with neuromuscular transmission (e.g. curare-like compounds) should be considered with caution.

 

Botulinum toxin type B [1], fertility ---> SmPC of [1] of EMA

No fertility studies have been performed and it is not known whether NeuroBloc can affect reproduction capacity.

 

Botulinum toxin type B [1], pregnancy ---> SmPC of [1] of EMA

NeuroBloc should not be used during pregnancy unless the clinical condition of the woman requires treatment with Botulinum Toxin Type B (see section 5.3).

 

Botulinum toxin type B [1], serotyps ---> SmPC of [1] of EMA

The effect of administering different botulinum neurotoxin serotypes concurrently is unknown. However, in clinical studies, NeuroBloc was administered 16 weeks after the injection of Botulinum Toxin Type A.

 

 

             CONTRAINDICATIONS of Botulinum toxin type B (NeuroBloc)

             - Individuals with known neuromuscular diseases (e.g. amyotrophic lateral sclerosis or peripheral neuropathy) or known neuromuscular junctional disorders (e.g. myasthenia    gravis or Lambert-Eaton syndrome) must not be given NeuroBloc.      

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

                          

             https://www.ema.europa.eu/en/documents/product-information/neurobloc-epar-product-information_en.pdf 04/05/2023 (withdrawn)           

 




Brentuximab vedotin (Adcetris)

Ability to drive, brentuximab vedotin [2] ---> SmPC of [2] of EMA

ADCETRIS may have a moderate influence on the ability to drive and use machines (e.g. dizziness), see section 4.8.

 

Bleomycin, brentuximab vedotin [2] ---> SmPC of [2] of EMA

No pulmonary toxicity or fatal events were reported with brentuximab vedotin + AVD. Therefore, co-administration of ADCETRIS with bleomycin is contraindicated (see section 4.3).

 

Breast-feeding, brentuximab vedotin [2] ---> SmPC of [2] of EMA

A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from this therapy, taking into account a potential risk of breast-feeding for the child and the benefit of therapy for the woman.

 

Brentuximab vedotin [1], CYP3A4 and P-glycoprotein-inhibitors ---> SmPC of [1] of EMA

The combination of brentuximab with a strong CYP3A4 and P glycoprotein inhibitor increased the exposure to the antimicrotubule agent MMAE and may increase the incidence of neutropenia.

 

Brentuximab vedotin [1], drugs metabolised by CYP3A4 ---> SmPC of [1] of EMA

Co-administration of midazolam, a CYP3A4 substrate, with brentuximab vedotin did not alter the metabolism of midazolam; therefore brentuximab vedotin is not expected to alter the exposure to medicines that are metabolized by CYP3A4 enzymes.

 

Brentuximab vedotin [1], fertility ---> SmPC of [1] of EMA

In non-clinical studies, brentuximab vedotin treatment has resulted in testicular toxicity, and may alter male fertility. MMAE has been shown to have aneugenic properties (see section 5.3).

 

Brentuximab vedotin [1], ketoconazole ---> SmPC of [1] of EMA

The combination of brentuximab with a strong CYP3A4 and P glycoprotein inhibitor increased the exposure to the antimicrotubule agent MMAE and may increase the incidence of neutropenia.

 

Brentuximab vedotin [1], men ---> SmPC of [1] of EMA

Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months following the last dose.

 

Brentuximab vedotin [1], midazolam ---> SmPC of [1] of EMA

Co-administration of midazolam, a CYP3A4 substrate, with brentuximab vedotin did not alter the metabolism of midazolam; therefore brentuximab vedotin is not expected to alter the exposure to medicines that are metabolized by CYP3A4 enzymes.

 

Brentuximab vedotin [1], peripheral neuropathy ---> SmPC of [1] of EMA

Brentuximab vedotin-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases.

 

Brentuximab vedotin [1], pregnancy ---> SmPC of [1] of EMA

ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus. If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the foetus.

 

Brentuximab vedotin [1], rifampicin ---> SmPC of [1] of EMA

Co-administration of brentuximab vedotin with rifampicin, a strong CYP3A4 inducer, did not alter the plasma exposure to brentuximab vedotin. Coadministration of rifampicin appeared to reduce plasma concentrations of MMAE metabolites that could be assayed

 

Brentuximab vedotin [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

The combination of brentuximab with a strong CYP3A4 inhibitor increased the exposure to the antimicrotubule agent MMAE and may increase the incidence of neutropenia.

 

Brentuximab vedotin [1], strong P-gp inhibitors ---> SmPC of [1] of EMA

The combination of brentuximab with a strong P-gp inhibitor increased the exposure to the antimicrotubule agent MMAE and may increase the incidence of neutropenia.

 

Brentuximab vedotin [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment.

 

Brentuximab vedotin, tabelecleucel [2] ---> SmPC of [2] of EMA

Certain concomitant or recently administered medicinal could potentially impact the efficacy of Ebvallo. Ebvallo should only be administered after an adequate washout period of such agents.

 

 

             CONTRAINDICATIONS of Brentuximab vedotin (Adcetris)       

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Combined use of bleomycin and ADCETRIS causes pulmonary toxicity.

              

             https://www.ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf 01/10/2025 






Brexpiprazole (Rxulti)

Ability to drive, brexpiprazole [2] ---> SmPC of [2] of EMA

Brexpiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system effects, such as sedation and dizziness that are common adverse drug reactions

 

Alcohol, brexpiprazole [2] ---> SmPC of [2] of EMA

Given the primary CNS effects of brexpiprazole, caution should be used when brexpiprazole is taken in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as opiates like codeine or morphine

 

Antihypertensives, brexpiprazole [2] ---> SmPC of [2] of EMA

RXULTI may increase the effect of medicines used to lower the blood pressure.

 

BCRP substrates, brexpiprazole [2] ---> SmPC of [2] of EMA

Brexpiprazole does not affect absorption of medicinal products that are substrates of Breast Cancer Resistance Protein transporter (BCRP) and P-glycoprotein (P-gp) transporter.

 

Bendroflumethiazide, brexpiprazole [2] ---> SmPC of [2] of EMA

If brexpiprazole is administered concomitantly with medicinal products known to cause QT prolongation (e.g. moxifloxacin) or electrolyte imbalance (e.g. diuretics such as furosemide, bendroflumethiazide), caution should be used.

 

Breast-feeding, brexpiprazole [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from brexpiprazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Brexpiprazole [1], carbamazepine ---> SmPC of [1] of EMA

If brexpiprazole is used concomitantly with strong CYP3A4 inducers, the total daily dose requirement of brexpiprazole is increased by approximately a factor of three times the recommended daily dose.

 

Brexpiprazole [1], clarithromycin ---> SmPC of [1] of EMA

Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP3A4 inhibitors

 

Brexpiprazole [1], codeine ---> SmPC of [1] of EMA

Given the primary CNS effects of brexpiprazole, caution should be used when brexpiprazole is taken in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as opiates like codeine or morphine

 

Brexpiprazole [1], CYP2D6 metabolisers ---> SmPC of [1] of EMA

Based on estimations from the population pharmacokinetic analysis, CYP2D6 extensive metabolisers receiving both CYP3A4 and CYP2D6 inhibitors or CYP2D6 poor metabolisers receiving strong CYP3A4 inhibitors are expected to have approximately 4-fold to 5-fold increase in brexpiprazole concentrations and dose adjustment to a quarter of the dose is recommended for these subjects

 

Brexpiprazole [1], cytochrome P450 ---> SmPC of [1] of EMA

Based on results of in vitro studies, brexpiprazole is unlikely to cause clinically important pharmacokinetic interactions with medicinal products metabolised by cytochrome P450 enzymes.

 

Brexpiprazole [1], diazepam ---> SmPC of [1] of EMA

Based on results of in vitro studies brexpiprazole protein binding is not affected by warfarin, diazepam, and digitoxin.

 

Brexpiprazole [1], digitoxin ---> SmPC of [1] of EMA

Based on results of in vitro studies brexpiprazole protein binding is not affected by warfarin, diazepam, and digitoxin.

 

Brexpiprazole [1], diuretics ---> SmPC of [1] of EMA

If brexpiprazole is administered concomitantly with medicinal products known to cause QT prolongation (e.g. moxifloxacin) or electrolyte imbalance (e.g. diuretics such as furosemide, bendroflumethiazide), caution should be used.

 

Brexpiprazole [1], drugs that increase creatine phosphokinase ---> SmPC of [1] of EMA

If brexpiprazole is administered concomitantly with medicinal products known to increase creatine phosphokinase (CPK), e.g. statins like simvastatin, the possible additive effect with CPK increase induced by brexpiprazole should be considered.

 

Brexpiprazole [1], electrolyte imbalance ---> SmPC of [1] of EMA

If brexpiprazole is administered concomitantly with medicinal products known to cause QT prolongation (e.g. moxifloxacin) or electrolyte imbalance (e.g. diuretics such as furosemide, bendroflumethiazide), caution should be used.

 

Brexpiprazole [1], fertility ---> SmPC of [1] of EMA

The effect of brexpiprazole on human fertility has not been evaluated. Studies in animals have shown decreased female fertility (see section 5.3).

 

Brexpiprazole [1], fluoxetine ---> SmPC of [1] of EMA

Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP2D6 inhibitors (quinidine, paroxetine, and fluoxetine).

 

Brexpiprazole [1], furosemide ---> SmPC of [1] of EMA

If brexpiprazole is administered concomitantly with medicinal products known to cause QT prolongation (e.g. moxifloxacin) or electrolyte imbalance (e.g. diuretics such as furosemide, bendroflumethiazide), caution should be used.

 

Brexpiprazole [1], itraconazol ---> SmPC of [1] of EMA

Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP3A4 inhibitors

 

Brexpiprazole [1], ketoconazole ---> SmPC of [1] of EMA

Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP3A4 inhibitors

 

Brexpiprazole [1], morphine ---> SmPC of [1] of EMA

Given the primary CNS effects of brexpiprazole, caution should be used when brexpiprazole is taken in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as opiates like codeine or morphine

 

Brexpiprazole [1], moxifloxacin ---> SmPC of [1] of EMA

If brexpiprazole is administered concomitantly with medicinal products known to cause QT prolongation (e.g. moxifloxacin) or electrolyte imbalance (e.g. diuretics such as furosemide, bendroflumethiazide), caution should be used.

 

Brexpiprazole [1], nervous system effects ---> SmPC of [1] of EMA

Given the primary CNS effects of brexpiprazole, caution should be used when brexpiprazole is taken in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as opiates like codeine or morphine

 

Brexpiprazole [1], opiates ---> SmPC of [1] of EMA

Given the primary CNS effects of brexpiprazole, caution should be used when brexpiprazole is taken in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as opiates like codeine or morphine

 

Brexpiprazole [1], P-glycoprotein substrates ---> SmPC of [1] of EMA

Brexpiprazole does not affect absorption of medicinal products that are substrates of Breast Cancer Resistance Protein transporter (BCRP) and P-glycoprotein (P-gp) transporter.

 

Brexpiprazole [1], paroxetine ---> SmPC of [1] of EMA

Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP2D6 inhibitors (quinidine, paroxetine, and fluoxetine).

 

Brexpiprazole [1], pharmacodynamics ---> SmPC of [1] of EMA

No information on pharmacodynamic interactions of brexpiprazole is available at present. Caution should be exercised when prescribing other medicinal products concomitantly.

 

Brexpiprazole [1], phenobarbital ---> SmPC of [1] of EMA

If brexpiprazole is used concomitantly with strong CYP3A4 inducers, the total daily dose requirement of brexpiprazole is increased by approximately a factor of three times the recommended daily dose.

 

Brexpiprazole [1], pregnancy ---> SmPC of [1] of EMA

Brexpiprazole is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

Brexpiprazole [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

If brexpiprazole is administered concomitantly with medicinal products known to cause QT prolongation (e.g. moxifloxacin) or electrolyte imbalance (e.g. diuretics such as furosemide, bendroflumethiazide), caution should be used.

 

Brexpiprazole [1], quinidine ---> SmPC of [1] of EMA

Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP2D6 inhibitors (quinidine, paroxetine, and fluoxetine).

 

Brexpiprazole [1], rifampicin ---> SmPC of [1] of EMA

If brexpiprazole is used concomitantly with strong CYP3A4 inducers, the total daily dose requirement of brexpiprazole is increased by approximately a factor of three times the recommended daily dose.

 

Brexpiprazole [1], ritonavir ---> SmPC of [1] of EMA

Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP3A4 inhibitors

 

Brexpiprazole [1], simvastatine ---> SmPC of [1] of EMA

If brexpiprazole is administered concomitantly with medicinal products known to increase creatine phosphokinase (CPK), e.g. statins like simvastatin, the possible additive effect with CPK increase induced by brexpiprazole should be considered.

 

Brexpiprazole [1], St. John's wort ---> SmPC of [1] of EMA

If brexpiprazole is used concomitantly with strong CYP3A4 inducers, the total daily dose requirement of brexpiprazole is increased by approximately a factor of three times the recommended daily dose.

 

Brexpiprazole [1], statins ---> SmPC of [1] of EMA

If brexpiprazole is administered concomitantly with medicinal products known to increase creatine phosphokinase (CPK), e.g. statins like simvastatin, the possible additive effect with CPK increase induced by brexpiprazole should be considered.

 

Brexpiprazole [1], strong CYP2D6 inhibitors ---> SmPC of [1] of EMA

Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP2D6 inhibitors (quinidine, paroxetine, and fluoxetine).

 

Brexpiprazole [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

If brexpiprazole is used concomitantly with strong CYP3A4 inducers, the total daily dose requirement of brexpiprazole is increased by approximately a factor of three times the recommended daily dose.

 

Brexpiprazole [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP3A4 inhibitors

 

Brexpiprazole [1], warfarin ---> SmPC of [1] of EMA

Based on results of in vitro studies brexpiprazole protein binding is not affected by warfarin, diazepam, and digitoxin.

 

 

             CONTRAINDICATIONS of Brexpiprazole (Rxulti)                        

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.       

             https://www.ema.europa.eu/en/documents/product-information/rxulti-epar-product-information_en.pdf 04/04/2025 





Brigatinib (Alunbrig)

Ability to drive, brigatinib [2] ---> SmPC of [2] of EMA

Caution should be exercised when driving or operating machines as patients may experience visual disturbance, dizziness, or fatigue while taking Alunbrig.

 

Alfentanyl, brigatinib [2] ---> SmPC of [2] of EMA

Coadministration of Alunbrig with CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus) should be avoided as their effectiveness may be reduced.

 

Azole antifungals, brigatinib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

BCRP substrates with narrow therapeutic range, brigatinib [2] ---> SmPC of [2] of EMA

Coadministration of brigatinib with substrates of P-gp, BCRP may increase their plasma concentrations. Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index

 

BCRP substrates, brigatinib [2] ---> SmPC of [2] of EMA

No dose adjustment is required for Alunbrig during coadministration with P-gp and BCRP inhibitors.

 

Bosentan, brigatinib [2] ---> SmPC of [2] of EMA

The concomitant use of moderate CYP3A inducers with Alunbrig, including but not limited to efavirenz, modafinil, bosentan, etravirine, and nafcillin should be avoided.

 

Breast-feeding, brigatinib [2] ---> SmPC of [2] of EMA

Breast-feeding should be stopped during treatment with Alunbrig.

 

Brigatinib [1], carbamazepine ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inducers with Alunbrig should be avoided

 

Brigatinib [1], clarithromycin ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], colchicine ---> SmPC of [1] of EMA

Coadministration of brigatinib with substrates of P-gp, BCRP may increase their plasma concentrations. Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index

 

Brigatinib [1], cyclosporine ---> SmPC of [1] of EMA

Coadministration of Alunbrig with CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus) should be avoided as their effectiveness may be reduced.

 

Brigatinib [1], dabigatran ---> SmPC of [1] of EMA

Coadministration of brigatinib with substrates of P-gp, BCRP may increase their plasma concentrations. Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index

 

Brigatinib [1], digoxin ---> SmPC of [1] of EMA

Coadministration of brigatinib with substrates of P-gp, BCRP may increase their plasma concentrations. Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index

 

Brigatinib [1], diltiazem ---> SmPC of [1] of EMA

No dose adjustment is required for Alunbrig in combination with moderate CYP3A inhibitors.

 

Brigatinib [1], drugs inducing bradycardia ---> SmPC of [1] of EMA

Caution should be exercised when administering Alunbrig in combination with other agents known to cause bradycardia.

 

Brigatinib [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA

Brigatinib may reduce plasma levels of coadministered medicinal products that are predominantly metabolised by CYP3A.

 

Brigatinib [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of EMA

Coadministration of Alunbrig with CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus) should be avoided as their effectiveness may be reduced.

 

Brigatinib [1], efavirenz ---> SmPC of [1] of EMA

The concomitant use of moderate CYP3A inducers with Alunbrig, including but not limited to efavirenz, modafinil, bosentan, etravirine, and nafcillin should be avoided.

 

Brigatinib [1], etravirine ---> SmPC of [1] of EMA

The concomitant use of moderate CYP3A inducers with Alunbrig, including but not limited to efavirenz, modafinil, bosentan, etravirine, and nafcillin should be avoided.

 

Brigatinib [1], fentanyl ---> SmPC of [1] of EMA

Coadministration of Alunbrig with CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus) should be avoided as their effectiveness may be reduced.

 

Brigatinib [1], fertility ---> SmPC of [1] of EMA

Based on repeat-dose toxicity studies in male animals, Alunbrig may cause reduced fertility in males (see section 5.3). The clinical relevance of these findings to human fertility is unknown.

 

Brigatinib [1], gemfibrozil ---> SmPC of [1] of EMA

No dose adjustment is required during coadministration with strong CYP2C8 inhibitors.

 

Brigatinib [1], grapefruit ---> SmPC of [1] of EMA

Grapefruit or grapefruit juice may also increase plasma concentrations of brigatinib and should be avoided

 

Brigatinib [1], grapefruit juice ---> SmPC of [1] of EMA

Grapefruit or grapefruit juice may also increase plasma concentrations of brigatinib and should be avoided

 

Brigatinib [1], indinavir ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], itraconazol ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], ketoconazole ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], macrolide antibiotics ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], methotrexate ---> SmPC of [1] of EMA

Coadministration of brigatinib with substrates of P-gp, BCRP may increase their plasma concentrations. Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index

 

Brigatinib [1], mibefradil ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], midazolam ---> SmPC of [1] of EMA

Brigatinib may reduce plasma levels of coadministered medicinal products that are predominantly metabolised by CYP3A.

 

Brigatinib [1], modafinil ---> SmPC of [1] of EMA

The concomitant use of moderate CYP3A inducers with Alunbrig, including but not limited to efavirenz, modafinil, bosentan, etravirine, and nafcillin should be avoided.

 

Brigatinib [1], nafcillin ---> SmPC of [1] of EMA

The concomitant use of moderate CYP3A inducers with Alunbrig, including but not limited to efavirenz, modafinil, bosentan, etravirine, and nafcillin should be avoided.

 

Brigatinib [1], nefazodone ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], nelfinavir ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA

No dose adjustment is required for Alunbrig during coadministration with P-gp and BCRP inhibitors.

 

Brigatinib [1], P-glycoprotein substrates with small therapeutic index ---> SmPC of [1] of EMA

Coadministration of brigatinib with substrates of P-gp, BCRP may increase their plasma concentrations. Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index

 

Brigatinib [1], phenobarbital ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inducers with Alunbrig should be avoided

 

Brigatinib [1], phenytoin ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inducers with Alunbrig should be avoided

 

Brigatinib [1], pravastatine ---> SmPC of [1] of EMA

Coadministration of brigatinib with substrates of P-gp, BCRP may increase their plasma concentrations. Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index

 

Brigatinib [1], pregnancy ---> SmPC of [1] of EMA

Alunbrig may cause foetal harm when administered to a pregnant woman. Alunbrig should not be used during pregnancy unless the clinical condition of the mother requires treatment.

 

Brigatinib [1], quinidine ---> SmPC of [1] of EMA

Coadministration of Alunbrig with CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus) should be avoided as their effectiveness may be reduced.

 

Brigatinib [1], rifabutin ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inducers with Alunbrig should be avoided

 

Brigatinib [1], rifampicin ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inducers with Alunbrig should be avoided

 

Brigatinib [1], ritonavir ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], rosuvastatin ---> SmPC of [1] of EMA

Coadministration of brigatinib with substrates of P-gp, BCRP may increase their plasma concentrations. Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index

 

Brigatinib [1], saquinavir ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], sirolimus ---> SmPC of [1] of EMA

Coadministration of Alunbrig with CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus) should be avoided as their effectiveness may be reduced.

 

Brigatinib [1], St. John's wort ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inducers with Alunbrig should be avoided

 

Brigatinib [1], strong CYP2C8 inhibitors ---> SmPC of [1] of EMA

No dose adjustment is required during coadministration with strong CYP2C8 inhibitors.

 

Brigatinib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

The concomitant use of Alunbrig with strong and moderate CYP3A inducers should be avoided

 

Brigatinib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

The concomitant use of Alunbrig with strong CYP3A inhibitors should be avoided.

 

Brigatinib [1], sulfasalazine ---> SmPC of [1] of EMA

Coadministration of brigatinib with substrates of P-gp, BCRP may increase their plasma concentrations. Patients should be closely monitored when Alunbrig is coadministered with substrates of these transporters with a narrow therapeutic index

 

Brigatinib [1], tacrolimus ---> SmPC of [1] of EMA

Coadministration of Alunbrig with CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus) should be avoided as their effectiveness may be reduced.

 

Brigatinib [1], telithromycin ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], troleandomycin ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], verapamil ---> SmPC of [1] of EMA

No dose adjustment is required for Alunbrig in combination with moderate CYP3A inhibitors.

 

Brigatinib [1], voriconazole ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors with Alunbrig should be avoided

 

Brigatinib [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing age being treated with Alunbrig should be advised not to become pregnant and men being treated with Alunbrig should be advised not to father a child during treatment.

 

             CONTRAINDICATIONS of Brigatinib (Alunbrig)    

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

              

             https://www.ema.europa.eu/documents/product-information/alunbrig-epar-product-information_en.pdf. 22/09/2023

              

 



Brimonidine (Mirvaso)

Alcohol, brimonidine [2] ---> SmPC of [2] of EMA

The possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.

 

Alfa-adrenergic agonists, brimonidine [2] ---> SmPC of [2] of EMA

Caution is advised when initiating (or changing the dose of a concomitant systemic substance which may interact with alpha adrenergic receptor agonists or interfere with their activity i.e. agonists or antagonists of the adrenergic receptor

 

Alfa-adrenergic receptor blockers, brimonidine [2] ---> SmPC of [2] of EMA

Caution is advised when initiating (or changing the dose of a concomitant systemic substance which may interact with alpha adrenergic receptor agonists or interfere with their activity i.e. agonists or antagonists of the adrenergic receptor

 

Anaesthetics, brimonidine [2] ---> SmPC of [2] of EMA

The possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.

 

Antihypertensives, brimonidine [2] ---> SmPC of [2] of EMA

Brimonidine may cause clinically insignificant decreases in blood pressure in some patients. Caution is therefore advised when using medicinal products such as anti-hypertensives and/or cardiac glycosides concomitantly with brimonidine.

 

Barbiturates, brimonidine [2] ---> SmPC of [2] of EMA

The possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.

 

Breast-feeding, brimonidine [2] ---> SmPC of [2] of EMA

It is unknown whether brimonidine/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Mirvaso should not be used during breast-feeding.

 

Brimonidine [1], cardiac glycosides ---> SmPC of [1] of EMA

Brimonidine may cause clinically insignificant decreases in blood pressure in some patients. Caution is therefore advised when using medicinal products such as anti-hypertensives and/or cardiac glycosides concomitantly with brimonidine.

 

Brimonidine [1], catecholamines ---> SmPC of [1] of EMA

No data on the level of circulating catecholamines after Mirvaso administration are available.

 

Brimonidine [1], chlorpromazine ---> SmPC of [1] of EMA

Caution, however, is advised in patients taking substances which can affect the metabolism and uptake of circulating amines e.g. chlorpromazine, methylphenidate, reserpine.

 

Brimonidine [1], CNS depressants ---> SmPC of [1] of EMA

The possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.

 

Brimonidine [1], fertility ---> SmPC of [1] of EMA

Brimonidine did not present any special reproductive or developmental hazard in animal species.

 

Brimonidine [1], IMAOs ---> SmPC of [1] of EMA

Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on tricyclic or tetracyclic antidepressants which affect noradrenergic transmission (see section 4.3).

 

Brimonidine [1], imipramine ---> SmPC of [1] of EMA

Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on tricyclic or tetracyclic antidepressants which affect noradrenergic transmission (see section 4.3).

 

Brimonidine [1], isoprenaline ---> SmPC of [1] of EMA

Caution is advised when initiating (or changing the dose of a concomitant systemic substance which may interact with alpha adrenergic receptor agonists or interfere with their activity i.e. agonists or antagonists of the adrenergic receptor

 

Brimonidine [1], maprotiline ---> SmPC of [1] of EMA

Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on tricyclic or tetracyclic antidepressants which affect noradrenergic transmission (see section 4.3).

 

Brimonidine [1], methylphenidate ---> SmPC of [1] of EMA

Caution, however, is advised in patients taking substances which can affect the metabolism and uptake of circulating amines e.g. chlorpromazine, methylphenidate, reserpine.

 

Brimonidine [1], mianserin ---> SmPC of [1] of EMA

Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on tricyclic or tetracyclic antidepressants which affect noradrenergic transmission (see section 4.3).

 

Brimonidine [1], mirtazapine ---> SmPC of [1] of EMA

Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on tricyclic or tetracyclic antidepressants which affect noradrenergic transmission (see section 4.3).

 

Brimonidine [1], opiates ---> SmPC of [1] of EMA

The possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.

 

Brimonidine [1], prazosin ---> SmPC of [1] of EMA

Caution is advised when initiating (or changing the dose of a concomitant systemic substance which may interact with alpha adrenergic receptor agonists or interfere with their activity i.e. agonists or antagonists of the adrenergic receptor

 

Brimonidine [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is preferable to avoid the use of Mirvaso during pregnancy.

 

Brimonidine [1], reserpine ---> SmPC of [1] of EMA

Caution, however, is advised in patients taking substances which can affect the metabolism and uptake of circulating amines e.g. chlorpromazine, methylphenidate, reserpine.

 

Brimonidine [1], sedatives ---> SmPC of [1] of EMA

The possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.

 

Brimonidine [1], tetracyclic antidepressant ---> SmPC of [1] of EMA

Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on tricyclic or tetracyclic antidepressants which affect noradrenergic transmission (see section 4.3).

 

Brimonidine [1], tricyclic antidepressant ---> SmPC of [1] of EMA

Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on tricyclic or tetracyclic antidepressants which affect noradrenergic transmission (see section 4.3).

 

 

             CONTRAINDICATIONS of Brimonidine (Mirvaso)

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Children aged less than 2 years.

             - Patients receiving monoamine oxidase (MAO) inhibitor therapy (for example selegiline or moclobemide) and patients on tricyclic (such as imipramine) or tetracyclic (such as maprotiline, mianserin or mirtazapine) antidepressants which affect noradrenergic transmission.

              

             https://www.ema.europa.eu/en/documents/product-information/mirvaso-epar-product-information_en.pdf 19/04/2023

 

Other trade names: Alfadina, Alphagan,

 




Brinzolamide (Azopt)

Ability to drive, brinzolamide [2] ---> SmPC of [2] of EMA

Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination (see also section 4.4 and section 4.8).

 

Ability to drive, brinzolamide [2] ---> SmPC of [2] of EMA

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines

 

Adrenergic agonists, brinzolamide [2] ---> SmPC of [2] of EMA

Association between AZOPT and miotics or adrenergic agonists has not been evaluated during adjunctive glaucoma therapy.

 

Breast-feeding, brinzolamide [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from AZOPT therapy taking in to account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Brinzolamide [1], carbonic anhydrase inhibitors ---> SmPC of [1] of EMA

AZOPT is a carbonic anhydrase inhibitor and, although administered topically, is absorbed systemically. Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.

 

Brinzolamide [1], clotrimazole ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide [1], cytochrome P450 ---> SmPC of [1] of EMA

Brinzolamide is not an inhibitor of cytochrome P-450 isozymes.

 

Brinzolamide [1], fertility ---> SmPC of [1] of EMA

Animal studies with brinzolamide demonstrated no effect on fertility. Studies have not been performed to evaluate the effect of topical ocular administration of brinzolamide on human fertility.

 

Brinzolamide [1], itraconazol ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide [1], ketoconazole ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide [1], miotics ---> SmPC of [1] of EMA

Association between AZOPT and miotics or adrenergic agonists has not been evaluated during adjunctive glaucoma therapy.

 

Brinzolamide [1], pregnancy ---> SmPC of [1] of EMA

AZOPT is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

Brinzolamide [1], prostaglandin analogues ---> SmPC of [1] of EMA

In clinical studies, AZOPT was used concomitantly with prostaglandin analogues and timolol ophthalmic preparations without evidence of adverse interactions.

 

Brinzolamide [1], ritonavir ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide [1], timolol ---> SmPC of [1] of EMA

In clinical studies, AZOPT was used concomitantly with prostaglandin analogues and timolol ophthalmic preparations without evidence of adverse interactions.

 

Brinzolamide [1], troleandomycin ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

 

             CONTRAINDICATIONS of Brinzolamide (Azopt)           

             - Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

             - Known hypersensitivity to sulphonamides

             - Severe renal impairment

             - Hyperchloraemic acidosis

              

             https://www.ema.europa.eu/en/documents/product-information/azopt-epar-product-information_en.pdf 06/01/2025 

 

Other trade names: Simbrinza,

 



          

Brinzolamide/brimonidine

 

Ability to drive, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Brinzolamide/brimonidine may cause dizziness, fatigue and/or drowsiness, which may impair the ability to drive or use machines.

 

Alcohol, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Caution is advised due to the possibility of an additive or potentiating effect of brinzolamide/brimonidine with CNS depressants

 

Alfa-adrenergic receptor blockers, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Caution is advised when initiating (or changing the dose of) a concomitant systemic medicinal products (irrespective of pharmaceutical form) which may interact with alfa-adrenergic agonists or interfere with their activity

 

Anaesthetics, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Caution is advised due to the possibility of an additive or potentiating effect of brinzolamide/brimonidine with CNS depressants

 

Antihypertensives, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Caution is advised when using medicinal products such as antihypertensives concomitantly with brinzolamide/brimonidine.

 

Barbiturates, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Caution is advised due to the possibility of an additive or potentiating effect of brinzolamide/brimonidine with CNS depressants

 

Beta-adrenergic agonists, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Caution is advised when initiating (or changing the dose of) a concomitant systemic medicinal products (irrespective of pharmaceutical form) which may interact with alfa-adrenergic agonists or interfere with their activity

 

Breast-feeding, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Brimonidine administered orally is excreted in breast milk. SIMBRINZA should not be used by women nursing infants.

 

Brinzolamide/brimonidine [1], carbonic anhydrase inhibitors ---> SPC of [1] of EMA

There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition. The concomitant administration of brinzolamide/brimonidine and oral carbonic anhydrase inhibitors is not recommended.

 

Brinzolamide/brimonidine [1], cardiac glycosides ---> SPC of [1] of EMA

Caution is advised when using medicinal products such as cardiac glycosides concomitantly with brinzolamide/brimonidine.

 

Brinzolamide/brimonidine [1], chlorpromazine ---> SPC of [1] of EMA

Caution is advised in patients taking substances which can affect the metabolism and uptake of circulating amines

 

Brinzolamide/brimonidine [1], clotrimazole ---> SPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide/brimonidine [1], isoprenaline ---> SPC of [1] of EMA

Caution is advised when initiating (or changing the dose of) a concomitant systemic medicinal products (irrespective of pharmaceutical form) which may interact with alfa-adrenergic agonists or interfere with their activity

 

Brinzolamide/brimonidine [1], itraconazol ---> SPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide/brimonidine [1], ketoconazole ---> SPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide/brimonidine [1], methylphenidate ---> SPC of [1] of EMA

Caution is advised in patients taking substances which can affect the metabolism and uptake of circulating amines

 

Brinzolamide/brimonidine [1], mianserin ---> SPC of [1] of EMA

The administration of brimonidine with medicinal products which affect noradrenergic transmission is contraindicated

 

Brinzolamide/brimonidine [1], opiates ---> SPC of [1] of EMA

Caution is advised due to the possibility of an additive or potentiating effect of brinzolamide/brimonidine with CNS depressants

 

Brinzolamide/brimonidine [1], prazosin ---> SPC of [1] of EMA

Caution is advised when initiating (or changing the dose of) a concomitant systemic medicinal products (irrespective of pharmaceutical form) which may interact with alfa-adrenergic agonists or interfere with their activity

 

Brinzolamide/brimonidine [1], pregnancy ---> SPC of [1] of EMA

SIMBRINZA is not recommended during pregnancy and in women of child bearing potential not using contraception.

 

Brinzolamide/brimonidine [1], reserpine ---> SPC of [1] of EMA

Caution is advised in patients taking substances which can affect the metabolism and uptake of circulating amines

 

Brinzolamide/brimonidine [1], ritonavir ---> SPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide/brimonidine [1], sedatives ---> SPC of [1] of EMA

Caution is advised due to the possibility of an additive or potentiating effect of brinzolamide/brimonidine with CNS depressants

 

Brinzolamide/brimonidine [1], strong CYP3A4 inhibitors ---> SPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide/brimonidine [1], tricyclic antidepressant ---> SPC of [1] of EMA

Brinzolamide/brimonidine is contraindicated in patients on antidepressants which affect noradrenergic transmission. Tricyclic antidepressants may blunt the ocular hypotensive response of brinzolamide/brimonidine

 

Brinzolamide/brimonidine [1], troleandomycin ---> SPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

CNS depressants, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Caution is advised due to the possibility of an additive or potentiating effect of brinzolamide/brimonidine with CNS depressants

 

IMAOs, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Brinzolamide/brimonidine is contraindicated in patients receiving monoamine oxidase inhibitors

 

SNRIs, brinzolamide/brimonidine [2] ---> SPC of [2] of EMA

Caution is advised in patients taking substances which can affect the metabolism and uptake of circulating amines

 

 

           CONTRAINDICATIONS of Brinzolamide/brimonidine

            

           - Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 or to sulphonamides

           - Patients receiving monoamine oxidase (MAO) inhibitor therapy

           - Patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)

           - Patients with severe renal impairment

           - Patients with hyperchloraemic acidosis

           - Neonates and infants under the age of 2 years

            

           http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003698/WC500170361.pdf.





Brinzolamide/timolol (Azarga)

Ability to drive, brinzolamide/timolol [2] ---> SmPC of [2] of EMA

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.

 

Acebutolol, oral antidiabetics ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Acid-base disturbances, brinzolamide/timolol [2] ---> SmPC of [2] of EMA

AZARGA contains brinzolamide, a carbonic anhydrase inhibitor and, although administered topically, is absorbed systemically. Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.

 

Adrenaline, brinzolamide/timolol [2] ---> SmPC of [2] of EMA

Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.

 

Amiodarone, brinzolamide/timolol [2] ---> SmPC of [2] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral anti-arrhythmics (including amiodarone)

 

Antiarrhythmics, brinzolamide/timolol [2] ---> SmPC of [2] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral anti-arrhythmics (including amiodarone)

 

Antidiabetics, carteolol ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of insulin. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Betablockers, brinzolamide/timolol [2] ---> SmPC of [2] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral beta-adrenergic blocking agents

 

Betablockers, metformin ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of insulin. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Betablockers, oral antidiabetics ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Betaxolol, oral antidiabetics ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Breast-feeding, brinzolamide/timolol [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from AZARGA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Brinzolamide/timolol [1], carbonic anhydrase ---> SmPC of [1] of EMA

The concomitant administration of eye drops containing brinzolamide and oral carbonic anhydrase inhibitors is not recommended.

 

Brinzolamide/timolol [1], carbonic anhydrase inhibitors ---> SmPC of [1] of EMA

There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition. The concomitant administration of eye drops containing brinzolamide and oral carbonic anhydrase inhibitors is not recommended.

 

Brinzolamide/timolol [1], clonidine ---> SmPC of [1] of EMA

The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking betablockers. Caution is recommended in the concomitant use of this medicinal product with clonidine.

 

Brinzolamide/timolol [1], clotrimazole ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide/timolol [1], digital glycosides ---> SmPC of [1] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral digitalis glycosides

 

Brinzolamide/timolol [1], fertility ---> SmPC of [1] of EMA

No effects on male or female fertility are anticipated from the use of AZARGA.

 

Brinzolamide/timolol [1], fluoxetine ---> SmPC of [1] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

 

Brinzolamide/timolol [1], guanethidine ---> SmPC of [1] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral guanethidine

 

Brinzolamide/timolol [1], insulin ---> SmPC of [1] of EMA

The beta-blocker may increase the hypoglycaemic effect of insulin. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Brinzolamide/timolol [1], itraconazol ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide/timolol [1], ketoconazole ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide/timolol [1], oral antidiabetics ---> SmPC of [1] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Brinzolamide/timolol [1], parasympathomimetics ---> SmPC of [1] of EMA

There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral parasympathomimetics

 

Brinzolamide/timolol [1], paroxetine ---> SmPC of [1] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

 

Brinzolamide/timolol [1], pregnancy ---> SmPC of [1] of EMA

AZARGA should not be used during pregnancy unless clearly necessary. To reduce the systemic absorption, see section 4.2.

 

Brinzolamide/timolol [1], quinidine ---> SmPC of [1] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

 

Brinzolamide/timolol [1], ritonavir ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide/timolol [1], strong CYP2D6 inhibitors ---> SmPC of [1] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

 

Brinzolamide/timolol [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Brinzolamide/timolol [1], troleandomycin ---> SmPC of [1] of EMA

It is expected that inhibitors of CYP3A4 will inhibit the metabolism of brinzolamide by CYP3A4. Caution is advised if CYP3A4 inhibitors are given concomitantly.

 

Insulin, levobunolol ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of insulin. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Insulin, oxprenolol ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Insulin, timolol ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Labetalol, oral antidiabetics ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Levobunolol, oral antidiabetics ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of insulin. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Metipranolol, oral antidiabetics ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of insulin. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Nadolol, oral antidiabetics ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Oral antidiabetics, oxprenolol ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Oral antidiabetics, pindolol ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

Oral antidiabetics, timolol ---> SmPC of [brinzolamide/timolol] of EMA

The beta-blocker may increase the hypoglycaemic effect of antidiabetic agent. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia

 

 

 

            CONTRAINDICATIONS of Brinzolamide/timolol (Azarga)  

            - Hypersensitivity to the active substances, or to any of the excipients listed in section 6.1.             

            - Hypersensitivity to other beta-blockers.           

            - Hypersensitivity to sulphonamides      

            - Reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease.     

            - Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker. Overt cardiac failure, cardiogenic shock.     

            - Severe allergic rhinitis  

            - Hyperchloraemic acidosis       

            - Severe renal impairment.        

 

            https://www.ema.europa.eu/en/documents/product-information/azarga-epar-product-information_en.pdf 06/01/2025             

 




Brivaracetam (Briviact)

Ability to drive, brivaracetam [2] ---> SmPC of [2] of EMA

Due to possible differences in individual sensitivity some patients might experience somnolence, dizziness, and other central nervous system (CNS) related symptoms.

 

Alcohol, brivaracetam [2] ---> SmPC of [2] of EMA

Brivaracetam approximately doubled the effect of alcohol on psychomotor function, attention and memory. Intake of brivaracetam with alcohol is not recommended.

 

Antiepileptics, brivaracetam [2] ---> SmPC of [2] of EMA

Discontinuation of anti-epileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.

 

Breast-feeding, brivaracetam [2] ---> SmPC of [2] of EMA

A decision should be made whether to discontinue breastfeeding or to discontinue brivaracetam, taking into account the benefit of the medicinal product to the mother.

 

Brivaracetam [1], cannabidiol ---> SmPC of [1] of EMA

Limited clinical data are available implying that coadministration of cannabidiol may increase the plasma exposure of brivaracetam, possibly through CYP2C19 inhibition, but the clinical relevance is uncertain.

 

Brivaracetam [1], carbamazepine ---> SmPC of [1] of EMA

Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required

 

Brivaracetam [1], CYP2C19 inhibitors ---> SmPC of [1] of EMA

Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low.

 

Brivaracetam [1], diazepam ---> SmPC of [1] of EMA

Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lansoprazole, omeprazole, diazepam).

 

Brivaracetam [1], drugs primarily metabolised by CYP2B6 ---> SmPC of [1] of EMA

Brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz).

 

Brivaracetam [1], drugs primarily metabolised by CYP2C19 ---> SmPC of [1] of EMA

Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lansoprazole, omeprazole, diazepam).

 

Brivaracetam [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA

Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4). The risk of clinically relevant CYP3A4 interactions is considered to be low.

 

Brivaracetam [1], efavirenz ---> SmPC of [1] of EMA

Brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz).

 

Brivaracetam [1], endogenous markers ---> SmPC of [1] of EMA

There was generally no change in the concentration-time profiles of the endogenous markers estradiol, progesterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), and sex hormone binding globulin (SHBG).

 

Brivaracetam [1], enzyme inductors ---> SmPC of [1] of EMA

Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the systemic exposure of brivaracetam. Therefore, starting or ending treatment with St John's wort should be done with caution.

 

Brivaracetam [1], fertility ---> SmPC of [1] of EMA

No human data on the effect of brivaracetam on fertility are available. In rats, there was no effect on fertility with brivaracetam (see section 5.3).

 

Brivaracetam [1], fluconazole ---> SmPC of [1] of EMA

Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low.

 

Brivaracetam [1], fluvoxamine ---> SmPC of [1] of EMA

Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low.

 

Brivaracetam [1], lansoprazole ---> SmPC of [1] of EMA

Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lansoprazole, omeprazole, diazepam).

 

Brivaracetam [1], levetiracetam ---> SmPC of [1] of EMA

In the clinical studies, although the numbers were limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently.

 

Brivaracetam [1], midazolam ---> SmPC of [1] of EMA

Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4). The risk of clinically relevant CYP3A4 interactions is considered to be low.

 

Brivaracetam [1], OAT3 inhibitors ---> SmPC of [1] of EMA

In vitro, Brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose. Brivaracetam 200mg/day may increase plasma concentrations of medicinal products transported by OAT3.

 

Brivaracetam [1], omeprazole ---> SmPC of [1] of EMA

Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lansoprazole, omeprazole, diazepam).

 

Brivaracetam [1], oral contraceptives ---> SmPC of [1] of EMA

Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance.

 

Brivaracetam [1], phenobarbital ---> SmPC of [1] of EMA

Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required

 

Brivaracetam [1], phenytoin ---> SmPC of [1] of EMA

Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required

 

Brivaracetam [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, brivaracetam should not be used during pregnancy unless clinically necessary i.e. (if the benefit to the mother clearly outweighs the potential risk to the foetus).

 

Brivaracetam [1], rifampicin ---> SmPC of [1] of EMA

In healthy subjects, coadministration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45 %.

 

Brivaracetam [1], St. John's wort ---> SmPC of [1] of EMA

Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the systemic exposure of brivaracetam. Therefore, starting or ending treatment with St John's wort should be done with caution.

 

Brivaracetam [1], strong enzyme inducing antiepileptic drugs ---> SmPC of [1] of EMA

Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required

 

Brivaracetam [1], women of childbearing potential ---> SmPC of [1] of EMA

Physicians should discuss family planning and contraception with women of childbearing potential taking brivaracetam (see Pregnancy). If a woman decides to become pregnant, the use of brivaracetam should be carefully re-evaluated.

 

 

            CONTRAINDICATIONS of Brivaracetam (Briviact)

            - Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.

 

            https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf 03/12/2024

 



          

Brivudine

 

Ability to drive, brivudine

Dizziness and somnolence may occur

 

Antineoplastics, brivudine

Co-administration of brivudine with chemotherapeutic drugs (particularly 5-FU, including its topic preparations and prodrugs) and other 5-fluoropyrimidines is contraindicated

 

Breast-feeding, brivudine

Contraindicated in breastfeeding

 

Brivudine, capecitabine

Co-administration of brivudine with chemotherapeutic drugs (particularly 5-FU, including its topic preparations and prodrugs) and other 5-fluoropyrimidines is contraindicated

 

Brivudine, dopamine agonists

The co-administration may cause chorea

 

Brivudine, dopaminergic drugs

The co-administration may cause chorea

 

Brivudine, floxuridine

Co-administration of brivudine with chemotherapeutic drugs (particularly 5-FU, including its topic preparations and prodrugs) and other 5-fluoropyrimidines is contraindicated

 

Brivudine, flucytosine

Concomitant use of brivudine with flucytosine is contraindicated

 

Brivudine, fluoropyrimidines

Co-administration of brivudine with chemotherapeutic drugs (particularly 5-FU, including its topic preparations and prodrugs) and other 5-fluoropyrimidines is contraindicated

 

Brivudine, fluorouracil

Co-administration of brivudine with chemotherapeutic drugs (particularly 5-FU, including its topic preparations and prodrugs) and other 5-fluoropyrimidines is contraindicated

 

Brivudine, pregnancy

Contraindicated during pregnancy

 

Brivudine, tegafur

Co-administration of brivudine with chemotherapeutic drugs (particularly 5-FU, including its topic preparations and prodrugs) and other 5-fluoropyrimidines is contraindicated

 

Brivudine, tegafur/gimeracil/oteracil [2] ---> SPC of [2] of EMA

Sorivudine or its chemically related analogues such as brivudine irreversibly inhibit DPD, resulting in a significant increase in 5-FU exposure. This may lead to increased clinically significant fluoropyrimidine-related toxicities with potentially fatal






Brodalumab (Kyntheum)

Breast-feeding, brodalumab [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Kyntheum therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Brodalumab [1], CYP3A4 substrates ---> SmPC of [1] of EMA

Based on the magnitude of change in exposure of midazolam, no dose adjustment of CYP3A4/3A5 substrates is necessary when administered concomitantly with Kyntheum.

 

Brodalumab [1], CYP450 enzymes ---> SmPC of [1] of EMA

The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g. IL-1, IL-6, IL-10, TNF?, IFN) during chronic inflammation.

 

Brodalumab [1], fertility ---> SmPC of [1] of EMA

No data are available on the effect of brodalumab on human fertility. Animal studies did not show any effects on male and female reproductive organs and on sperm count, motility and morphology (see section 5.3).

 

Brodalumab [1], midazolam ---> SmPC of [1] of EMA

In patients with moderate to severe plaque psoriasis, a single subcutaneous dose of 210 mg brodalumab increased the exposure of midazolam, a CYP3A4/3A5 substrate by 24%.

 

Brodalumab [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is preferable to avoid the use of Kyntheum in pregnancy.

 

Brodalumab [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

Live vaccines should not be given concurrently with brodalumab (see section 4.4).

 

Brodalumab [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential should use an effective method of contraception during treatment and for at least 12 weeks after treatment.

 

 

 

            CONTRAINDICATIONS of Brodalumab (Kyntheum)          

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  

            - Active Crohn’s disease.            

            - Clinically important active infections (e.g. active tuberculosis, see section 4.4).    

 

            https://www.ema.europa.eu/en/documents/product-information/kyntheum-epar-product-information_en.pdf brolucizumab 

 





Brolucizumab (Beovu)

Ability to drive, brolucizumab [2] ---> SmPC of [2] of EMA

Patients should not drive or use machines until visual function has recovered sufficiently.

 

Breast-feeding, brolucizumab [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast-feeding or to abstain from brolucizumab therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Breast-feeding, brolucizumab [2] ---> SmPC of [2] of EMA

Brolucizumab is not recommended during breast-feeding and breast-feeding should not be started for at least one month after the last dose when stopping treatment with brolucizumab.

 

Brolucizumab [1], fertility ---> SmPC of [1] of EMA

VEGF inhibition has been shown to affect follicular development, corpus luteum function and fertility. Based on the mechanism of action of VEGF inhibitiors, there is a potential risk for female reproduction.

 

Brolucizumab [1], pregnancy ---> SmPC of [1] of EMA

Although the systemic exposure after ocular administration is very low, brolucizumab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.

 

Brolucizumab [1], VEGF inhibitors ---> SmPC of [1] of EMA

Brolucizumab should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular).

 

Brolucizumab [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential should use effective contraception during treatment with brolucizumab and for at least one month after the last dose when stopping treatment with brolucizumab.

 

 

 

            CONTRAINDICATIONS of Brolucizumab (Beovu)  

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  

            - Patients with active or suspected ocular or periocular infections.          

            - Patients with active intraocular inflammation.    

 

            https://www.ema.europa.eu/en/documents/product-information/beovu-epar-product-information_en.pdf 27/08/2024             

 




 

Bromazepam

 

Ability to drive, bromazepam

Sedation, amnesia, decreased concentration ability and impaired muscular function may occur

 

Alcohol, bromazepam

Enhancement of the depressor effect on the central nervous system

 

Anaesthetics, bromazepam

Enhancement of the depressor effect on the central nervous system

 

Antidepressants, bromazepam

Enhancement of the depressor effect on the central nervous system

 

Antiepileptics, bromazepam

Enhancement of the depressor effect on the central nervous system

 

Anxiolytics, bromazepam

Enhancement of the depressor effect on the central nervous system

 

Benzodiazepines, breast-feeding

Since benzodiazepines are found in the breast milk, benzodiazepines should not be given to breast feeding mothers.

 

Breast-feeding, bromazepam

Since benzodiazepines are found in the breast milk, benzodiazepines should not be given to breast feeding mothers.

 

Bromazepam, cimetidine

Concomitant use with cimetidine can lengthen the elimination half-life of bromazepam

 

Bromazepam, enzyme inhibitors

Substances that inhibit certain hepatic enzymes (cytochrome P450) may enhance the effects of the benzodiazepines metabolized by these enzymes

 

Bromazepam, hypnotics

Enhancement of the depressor effect on the central nervous system

 

Bromazepam, lithium

Enhancement of the depressor effect on the central nervous system

 

Bromazepam, muscle relaxants

The co-administration of bromazepam with muscle relaxants may enhance the muscle-relaxant effect

 

Bromazepam, neuroleptics

Enhancement of the depressor effect on the central nervous system

 

Bromazepam, opioid analgesics

Enhancement of the central depressive effect may occur and enhancement of the euphoria that may lead to an increased risk in psychic dependence

 

Bromazepam, pregnancy

Bromazepam should not be used in pregnant women unless clearly necessary

 

Bromazepam, sedating antihistamines

Enhancement of the depressor effect on the central nervous system

 

Bromazepam, sedatives

Enhancement of the depressor effect on the central nervous system

 

CNS depressants, bromazepam

Enhancement of the depressor effect on the central nervous system


 

 


Bromfenac (Yellox)

Ability to drive, bromfenac [2] ---> SmPC of [2] of EMA

Transient blurring of vision may occur on instillation

 

Antibiotics, bromfenac [2] ---> SmPC of [2] of EMA

No interaction studies have been performed. No interactions with antibiotic eye drops used in conjunction with surgery have been reported.

 

Breast-feeding, bromfenac [2] ---> SmPC of [2] of EMA

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to bromfenac is negligible. Yellox can be used during breast-feeding.

 

Bromfenac [1], fertility ---> SmPC of [1] of EMA

No effects of bromfenac on the fertility were observed in animal studies. In addition the systemic exposure to bromfenac is negligible; for this reason no pregnancy testing or contraceptive measures are required.

 

Bromfenac [1], pregnancy ---> SmPC of [1] of EMA

Since the systemic exposure in non-pregnant women is negligible after treatment with Yellox, the risk during pregnancy could be considered low.

 

 

 

            CONTRAINDICATIONS of Bromfenac (Yellox)    

            - Hypersensitivity to bromfenac or to any of the excipients listed in section 6.1, or to other non-steroidal anti-inflammatory medicinal products (NSAIDs).   

            - Yellox is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other medicinal products with prostaglandin synthetase inhibiting activity.         

 

            https://www.ema.europa.eu/en/documents/product-information/yellox-epar-product-information_en.pdf  21/01/2025            

 




          

Bromhexine

 

Ability to drive, bromhexine

Dizziness may occur

 

Anticholinergics, bromhexine

Bronchial secretion inhibitors may antagonize the effects of bromhexine

 

Antihistamines, bromhexine

Bronchial secretion inhibitors may antagonize the effects of bromhexine

 

Antitussives, bromhexine

Dangerous secretory congestion due to the reduced cough reflex. Co-administration is not recommended

 

Breast-feeding, bromhexine

Bromhexine passes into the mother milk und should not be used during breast-feeding

 

Bromhexine, neuroleptics

Bronchial secretion inhibitors may antagonize the effects of bromhexine

 

Bromhexine, pregnancy

Bromhexine crosses the placental barrier. As a precautionary measure, it is preferable to avoid the use of bromhexine during pregnancy.

 

Bromhexine, tricyclic antidepressant

Bronchial secretion inhibitors may antagonize the effects of bromhexine

 

IMAOs, bromhexine

Bronchial secretion inhibitors may antagonize the effects of bromhexine

 


 

Bromocriptine

 

Ability to drive, bromocriptine [2] ---> SPC of [2] of eMC

Hypotensive reactions may be disturbing in some patients during the first few days of treatment and particular care should be exercised when driving vehicles or operating machinery.

 

Alcohol, bromocriptine [2] ---> SPC of [2] of eMC

Tolerance to bromocriptine may be reduced by alcohol.

 

Amisulpride [1], bromocriptine ---> SPC of [1] of eMC

Amisulpride may oppose the effect of dopamine agonists. The combination is contraindicated

 

Antihypertensives, bromocriptine

Caution is required in patients who are on concomitant therapy with, or have recently been treated with drugs that can alter blood pressure.

 

Azole antifungals, bromocriptine [2] ---> SPC of [2] of eMC

Bromocriptine is both a substrate and an inhibitor of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors and/or substrates of this enzyme

 

Breast-feeding, bromocriptine [2] ---> SPC of [2] of eMC

Since bromocriptine inhibits lactation, it should not be administered to mothers who elect to breast-feed.

 

Bromocriptine [1], butyrophenones ---> SPC of [1] of eMC

Dopamine antagonists may reduce the prolactin-lowering and antiparkinsonian effects of bromocriptine.

 

Bromocriptine [1], domperidone ---> SPC of [1] of eMC

Dopamine antagonists may reduce the prolactin-lowering and antiparkinsonian effects of bromocriptine.

 

Bromocriptine [1], dopamine antagonists ---> SPC of [1] of eMC

Dopamine antagonists may reduce the prolactin-lowering and antiparkinsonian effects of bromocriptine.

 

Bromocriptine [1], drugs primarily metabolised by CYP3A4 ---> SPC of [1] of eMC

Bromocriptine is both a substrate and an inhibitor of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors and/or substrates of this enzyme

 

Bromocriptine [1], erythromycin ---> SPC of [1] of eMC

The concomitant use of erythromycin and other macrolide antibiotics may increase bromocriptine plasma levels.

 

Bromocriptine [1], foods ---> SPC of [1] of eMC

Bromocriptine should always be taken with food.

 

Bromocriptine [1], josamycin ---> SPC of [1] of eMC

The concomitant use of erythromycin and other macrolide antibiotics may increase bromocriptine plasma levels.

 

Bromocriptine [1], levodopa ---> SPC of [1] of eMC

Combination with levodopa treatment results in enhanced anti-Parkinsonian effects, often making possible a reduction of the levodopa dose.

 

Bromocriptine [1], macrolide antibiotics ---> SPC of [1] of eMC

The concomitant use of erythromycin and other macrolide antibiotics may increase bromocriptine plasma levels.

 

Bromocriptine [1], metoclopramide ---> SPC of [1] of eMC

Dopamine antagonists may reduce the prolactin-lowering and antiparkinsonian effects of bromocriptine.

 

Bromocriptine [1], neuroleptics ---> SPC of [1] of eMC

Dopamine antagonists may reduce the prolactin-lowering and antiparkinsonian effects of bromocriptine.

 

Bromocriptine [1], octreotide ---> SPC of [1] of eMC

The concomitant treatment of acromegalic patients with bromocriptine and octreotide led to increased plasma levels of bromocriptine.

 

Bromocriptine [1], phenothiazines ---> SPC of [1] of eMC

Dopamine antagonists may reduce the prolactin-lowering and antiparkinsonian effects of bromocriptine.

 

Bromocriptine [1], pregnancy ---> SPC of [1] of eMC

If pregnancy occurs it is generally advisable to withdraw bromocriptine after the first missed menstrual period.

 

Bromocriptine [1], protease inhibitors ---> SPC of [1] of eMC

Bromocriptine is both a substrate and an inhibitor of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors and/or substrates of this enzyme

 

Bromocriptine [1], strong CYP3A4 inhibitors ---> SPC of [1] of eMC

Bromocriptine is both a substrate and an inhibitor of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors and/or substrates of this enzyme

 

Bromocriptine [1], thioxanthenes ---> SPC of [1] of eMC

Dopamine antagonists may reduce the prolactin-lowering and antiparkinsonian effects of bromocriptine.

 

Bromocriptine, bromperidol

The co-administration may decrease the effect of bromocriptine

 

Bromocriptine, chlorpromazine [2] ---> SPC of [2] of eMC

Reciprocal antagonism of dopaminergic antiparkinsonian agent and chlorpromazine. The combination is not recommended

 

Bromocriptine, cyclosporine

The inhibition of P-glycoprotein may lead to increased bioavailability of oral cyclosporine

 

Bromocriptine, desloratadine/pseudoephedrine [2] ---> SPC of [2] of EMA

The combination is not recommended

 

Bromocriptine, droperidol [2] ---> SPC of [2] of eMC

Since droperidol blocks dopamine receptors, it may inhibit the action of dopamine agonists, such as bromocriptine, lisuride, and of L-dopa.

 

Bromocriptine, ergot derivatives

Although there is no conclusive evidence of an interaction between bromocriptine and other ergot alkaloids concomitant use of bromocriptine with these medications during the puerperium is not recommended

 

Bromocriptine, flupentixol

The co-administration may weaken the effect of dopamine agonist

 

Bromocriptine, fluphenazine

The co-administration may weaken the effect of dopamine agonist

 

Bromocriptine, griseofulvin

Abolished effect of bromocriptine

 

Bromocriptine, lanreotide [2] ---> SPC of [2] of eMC

Limited published data indicate that concomitant administration of somatostatin analogues and bromocriptine may increase the availability of bromocriptine.

 

Bromocriptine, methylergometrine [2]

Although there is no conclusive evidence of an interaction between bromocriptine and other ergot alkaloids concomitant use of bromocriptine with these medications during the puerperium is not recommended

 

Bromocriptine, perazine

The co-administration may weaken the effect of dopamine agonist

 

Bromocriptine, perphenazine

The co-administration may weaken the effect of dopamine agonist

 

Bromocriptine, pipamperone

Pipamperone may inhibit the dopamine agonist effect

 

Bromocriptine, prothipendyl

Prothipendyl, dopamine D1 and D2 antagonist, may antagonize with the dopamine receptor agonist

 

Bromocriptine, protirelin

Reduction of TSH-increase

 

Bromocriptine, pseudoephedrine

Risk of vasoconstriction and increased blood pressure. Concomitant use not recommended

 

Bromocriptine, roxithromycin

Roxitromycin may increase significantly the absolute bioavailibility and the plasma levels of bromocriptine

 

Bromocriptine, sirolimus [2] ---> SPC of [2] of EMA

Inhibitors of CYP3A4 may decrease the metabolism of sirolimus and increase sirolimus blood levels.

 

Bromocriptine, somatostatin analogues ---> SPC of [lanreotide] of eMC

Limited published data indicate that concomitant administration of somatostatin analogues and bromocriptine may increase the availability of bromocriptine.

 

Bromocriptine, tacrolimus [2] ---> SPC of [2] of EMA

Possible inhibition of the tacrolimus metabolism

 

Bromocriptine, tamoxifen

Tamoxifen may cancel de effect of bromocriptine

 

Bromocriptine, tiapride

Concomitant use of tiapride and dopaminergic agonists, except levodopa, is not recommended in patients with Parkinson disease due to mutual antagonism between dopaminergic agonists and neuroleptics

 

Bromocriptine, zolmitriptan

Additive vasoconstrictive effects. The combination increases the risk of serotonin syndrome.

 

IMAOs, bromocriptine

Decreased effect of bromocriptine

 

 

           CONTRAINDICATIONS of Bromocriptine

            

           - Hypersensitivity to bromocriptine or to any of the excipients or to other ergot alkaloids.

           - Uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy induced hypertension), hypertension post partum and in the puerperium.

           - PARLODEL is contraindicated for use in the suppression of lactation or other non-life threatening indications in patients with a history of coronary

           artery disease or other severe cardiovascular conditions, or symptoms / history of severe psychiatric disorders.

           - Patients with severe cardiovascular disorders or psychiatric disorders taking PARLODEL for the indication of macroadenomas should only take it if the perceived benefits outweigh the potential risks

           - For long-term treatment: Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.

            

           http://www.medicines.org.uk/emc/


 

 

Brotizolam

 

Ability to drive, brotizolam

Brotizolam may cause somnolence

 

Alcohol, brotizolam

Concomitant intake with alcohol should be avoided due to the effect of brotizolam may be altered or potentiated in an unpredictable way

 

Anaesthetics, brotizolam

The co-administration of brotizolam with other central nervous system depressants may enhance the central nervous depressant effect

 

Antidepressants, brotizolam

The co-administration of brotizolam with other central nervous system depressants may enhance the central nervous depressant effect

 

Antiepileptics, brotizolam

The co-administration of brotizolam with other central nervous system depressants may enhance the central nervous depressant effect

 

Anxiolytics, brotizolam

The co-administration of brotizolam with other central nervous system depressants may enhance the central nervous depressant effect

 

Azole antifungals, brotizolam

The strong CYP3A4 inhibition may increase the plasma concentrations of brotizolam

 

Breast-feeding, brotizolam

Brotizolam should not be used during breastfeeding

 

Brotizolam, carbamazepine

Carbamazepine, strong CYP3A4 inductor, may decrease the plasma concentrations of brotizolam

 

Brotizolam, cimetidine

The CYP3A4 inhibition may increase the plasma concentrations of brotizolam

 

Brotizolam, efavirenz

The strong CYP3A4 induction may decrease the plasma concentrations of brotizolam

 

Brotizolam, grapefruit juice

The strong CYP3A4 inhibition may increase the plasma concentrations of brotizolam

 

Brotizolam, hypnotics

The co-administration of brotizolam with other central nervous system depressants may enhance the central nervous depressant effect

 

Brotizolam, imatinib [2] ---> SPC of [2] of EMA

The CYP3A4 inhibition may increase plasma concentrations of the triazolobenzodiazepine

 

Brotizolam, itraconazol [2] ---> SPC of [2] of eMC

Itraconazole may increase the plasma concentrations of brotizolam. Use with caution

 

Brotizolam, ketoconazole

The strong CYP3A4 inhibition may increase the plasma concentrations of brotizolam

 

Brotizolam, macrolide antibiotics

The strong CYP3A4 inhibition may increase the plasma concentrations of brotizolam

 

Brotizolam, muscle relaxants

The co-administration of brotizolam and muscle relaxant drugs may enhance the muscle relaxant effect

 

Brotizolam, neuroleptics

The co-administration of brotizolam with other central nervous system depressants may enhance the central nervous depressant effect

 

Brotizolam, nevirapine

The strong CYP3A4 induction may decrease the plasma concentrations of brotizolam

 

Brotizolam, opioid analgesics

The co-administration of brotizolam with other central nervous system depressants may enhance the central nervous depressant effect. Enhancement of the euphoria that may lead to an increased risk in psychic dependence

 

Brotizolam, phenobarbital

The strong CYP3A4 induction may decrease the plasma concentrations of brotizolam

 

Brotizolam, phenytoin

The strong CYP3A4 induction may decrease the plasma concentrations of brotizolam

 

Brotizolam, pregnancy

Brotizolam should not be used during pregnancy

 

Brotizolam, primidone

The strong CYP3A4 induction may decrease the plasma concentrations of brotizolam

 

Brotizolam, protease inhibitors

The strong CYP3A4 inhibition may increase the plasma concentrations of brotizolam

 

Brotizolam, rifabutin

The strong CYP3A4 induction may decrease the plasma concentrations of brotizolam

 

Brotizolam, rifampicin

The strong CYP3A4 induction may decrease the plasma concentrations of brotizolam

 

Brotizolam, sedating antihistamines

The co-administration of brotizolam with other central nervous system depressants may enhance the central nervous depressant effect

 

Brotizolam, sedatives

The co-administration of brotizolam with other central nervous system depressants may enhance the central nervous depressant effect

 

Brotizolam, strong CYP3A4 inductors

The strong CYP3A4 induction may decrease the plasma concentrations of brotizolam

 

Brotizolam, strong CYP3A4 inhibitors

The strong CYP3A4 inhibition may increase the plasma concentrations of brotizolam

 

CNS depressants, brotizolam

The co-administration of brotizolam with other central nervous system depressants may enhance the central nervous depressant effect

 

CYP3A4 inductors, brotizolam

The CYP3A4 induction may decrease the plasma concentrations of brotizolam

 

CYP3A4 inhibitors, brotizolam

The CYP3A4 inhibition may increase the plasma concentrations of brotizolam

 

St. John's wort, brotizolam

The strong CYP3A4 induction may decrease the plasma concentrations of brotizolam

 

 

 

Brovanexine

 

Anticholinergics, brovanexine

The concomitant use of brovanexine and drugs that inhibit the bronchial secretions is not recommended

 

Antihistamines, brovanexine

The concomitant use of brovanexine and drugs that inhibit the bronchial secretions is not recommended

 

Antitussives, brovanexine

The cough reflex inhibition may cause secretion congestion

 

Breast-feeding, brovanexine

The administration during breastfeeding is not recommended

 

Brovanexine, pregnancy

The administration during pregnancy is not recommended


 

 


 

Budesonide (Jorveza)

Antacids, budesonide

The co-administration may decrease the absorption of budesonide. They should not be taken simultaneously, but at least 2 hours apart

 

Atazanavir/cobicistat [1], budesonide ---> SmPC of [1] of EMA

Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.

 

Breast-feeding, budesonide [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

 

Budesonide [1], carbamazepine ---> SmPC of [1] of eMC

Concomitant treatment of budesonide with CYP3A4 inducers may reduce budesonide exposure, which may require a dose increase.

 

Budesonide [1], cholestyramine ---> SmPC of [1] of eMC

Concomitant administration of colestyramine may reduce budesonide uptake, in common with other drugs.

 

Budesonide [1], clarithromycin ---> SmPC of [1] of EMA

Co-treatment with potent CYP3A inhibitors may cause a marked increase of the plasma concentration of budesonide and is expected to increase the risk of systemic adverse reactions. Therefore, concomitant use should be avoided

 

Budesonide [1], digital glycosides ---> SmPC of [1] of EMA

The action of glycoside can be potentiated by potassium deficiency which is a potential and known adverse reaction of glucocorticoids.

 

Budesonide [1], estrogens ---> SmPC of [1] of EMA

Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported in women also receiving oestrogens or oral contraceptives.

 

Budesonide [1], fertility ---> SmPC of [1] of EMA

There are no data on the effect of budesonide on human fertility. Fertility was unaffected following budesonide treatment in animal studies (see section 5.3).

 

Budesonide [1], grapefruit juice ---> SmPC of [1] of EMA

Co-treatment with potent CYP3A inhibitors may cause a marked increase of the plasma concentration of budesonide and is expected to increase the risk of systemic adverse reactions. Therefore, concomitant use should be avoided

 

Budesonide [1], itraconazol ---> SmPC of [1] of EMA

Co-treatment with potent CYP3A inhibitors may cause a marked increase of the plasma concentration of budesonide and is expected to increase the risk of systemic adverse reactions. Therefore, concomitant use should be avoided

 

Budesonide [1], natriuretic agents ---> SmPC of [1] of EMA

Concomitant use of glucocorticoids may result in enhanced potassium excretion and aggravated hypokalaemia.

 

Budesonide [1], oral contraceptives ---> SmPC of [1] of EMA

Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported in women also receiving oestrogens or oral contraceptives.

 

Budesonide [1], pregnancy ---> SmPC of [1] of EMA

Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Jorveza.

 

Budesonide [1], rifampicin ---> SmPC of [1] of eMC

Concomitant treatment of budesonide with CYP3A4 inducers may reduce budesonide exposure, which may require a dose increase.

 

Budesonide [1], strong CYP3A4 inductors ---> SmPC of [1] of eMC

Concomitant treatment of budesonide with CYP3A4 inducers may reduce budesonide exposure, which may require a dose increase.

 

Budesonide [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Co-treatment with potent CYP3A inhibitors may cause a marked increase of the plasma concentration of budesonide and is expected to increase the risk of systemic adverse reactions. Therefore, concomitant use should be avoided

 

Budesonide, cobicistat [2] ---> SmPC of [2] of EMA

Corticosteroids primarily metabolised by CYP3A. Plasma concentrations of these medicinal products may be increased when co-administered with cobicistat, resulting in reduced serum cortisol concentrations.

 

Budesonide, coumarin anticoagulants

Decreased anticoagulant effect

 

Budesonide, cyclosporine ---> SmPC of [budesonide/formoterol] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide, darunavir/cobicistat [2] ---> SmPC of [2] of EMA

Concomitant use of REZOLSTA and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.

 

Budesonide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Based on theoretical considerations DRV/COBI is expected to increase this corticosteroid plasma concentrations. CYP3A inhibition

 

Budesonide, darunavir/ritonavir ---> SmPC of [darunavir] of EMA

Concomitant administration of boosted darunavir and the glucocorticoid is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects.

 

Budesonide, drugs metabolised by CYP3A4

The principle active metabolized by CYP3A4 may compete with budesonide. This may increase/decrease the budesonide plasma concentrations

 

Budesonide, drugs primarily metabolised by CYP3A4

The principle active metabolized by CYP3A4 may compete with budesonide. This may increase/decrease the budesonide plasma concentrations

 

Budesonide, duvelisib [2] ---> SmPC of [2] of EMA

Dose reduction of CYP3A4 substrate should be considered when co-administered with duvelisib, especially for medicinal products with narrow therapeutic index.

 

Budesonide, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Concomitant use of Genvoya and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.

 

Budesonide, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Concomitant use of Stribild and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.

 

Budesonide, erythromycin ---> SmPC of [budesonide/formoterol] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide, hydantoins

The strong CYP3A4 induction may decrease the plasma concentrations of glucocorticoid

 

Budesonide, idelalisib [2] ---> SmPC of [2] of EMA

The co-administration of idelalisib with budesonide may increase the serum concentrations of budesonide. Clinical monitoring is recommended (inhaled) for increased signs/symptoms of corticosteroid effects (oral).

 

Budesonide, ketoconazole [2] ---> SmPC of [2] of EMA

Increased in plasma concentrations of budesonide have been observed. Not recommended unless necessary. Careful monitoring and dose adjustment of this drug may be required

 

Budesonide, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA

Concomitant use of Kaletra and fluticasone or other glucocorticoids that are metabolised by CYP3A4, such as budesonide, is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects

 

Budesonide, nefazodone ---> SmPC of [budesonide/formoterol] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA

Systemic corticosteroid effects have been reported. Therefore, concomitant administration of ritonavir with corticosteroids metabolised by CYP3A is not recommended or switch to one, which is not a substrate for CYP3A4 (e.g., beclomethasone).

 

Budesonide, posaconazole ---> SmPC of [budesonide/formoterol] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide, protease inhibitors ---> SmPC of [budesonide/formoterol] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide, ritonavir [2] ---> SmPC of [2] of EMA

Concomitant use of ritonavir and budesonide/other glucocorticoids that are metabolised by CYP3A4, risk of systemic corticosteroid effects.

 

Budesonide, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA

Concomitant use of saquinavir/ritonavir and budesonide or other glucocorticoids that are metabolised by CYP3A4. Risk of systemic corticosteroid effects.

 

Budesonide, simeprevir [2] ---> SmPC of [2] of EMA

No clinically relevant drug-drug interaction is expected. No dose adjustment is required

 

Budesonide, telaprevir [2] ---> SmPC of [2] of EMA

Telaprevir, CYP3A4 inhibitor, may increase the plasma levels of budesonide. Co-administration is not recommended

 

Budesonide, telithromycin ---> SmPC of [budesonide/formoterol] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide, troleandomycin ---> SmPC of [budesonide/formoterol] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide, voriconazole ---> SmPC of [budesonide/formoterol] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

 

             CONTRAINDICATIONS of Budesonide (Jorveza)                        

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.       

                          

             https://www.ema.europa.eu/en/documents/product-information/jorveza-epar-product-information_en.pdf. 06/12/2022      

 

Other trade names: Budena, BUDESONIDA Easyhaler®, Entocord, Intestifalk, Miflonide, Novopulm Novolizer, Olfex Bucal, Pulmicort, Rhinocort, Ribujet,    

                        

 



Budesonide/formoterol (BiResp Spiromax)

Alcohol, budesonide/formoterol [2] ---> SmPC of [2] of EMA

In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2- sympathomimetics.

 

Anticholinergics, budesonide/formoterol [2] ---> SmPC of [2] of EMA

Concomitant use of beta adrenergic medicinal products and anticholinergic medicinal products can have a potentially additive bronchodilating effect.

 

Beta-adrenergic receptor blockers, budesonide/formoterol [2] ---> SmPC of [2] of EMA

Beta-adrenergic blockers can weaken or inhibit the effect of formoterol. A fixed-dose combination therapy of budesonide and formoterol should therefore not be given together with beta adrenergic blockers (including eye drops)

 

Breast-feeding, budesonide/formoterol [2] ---> SmPC of [2] of EMA

Administration of a fixed-dose combination therapy of budesonide and formoterol fumarate to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

 

Budesonide/formoterol [1], clarithromycin ---> SmPC of [1] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide/formoterol [1], digital glycosides ---> SmPC of [1] of EMA

Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.

 

Budesonide/formoterol [1], disopyramide ---> SmPC of [1] of EMA

Concomitant treatment of formoterol with disopyramide can prolong the QTc-interval and increase the risk of ventricular arrhythmias.

 

Budesonide/formoterol [1], fertility ---> SmPC of [1] of EMA

There is no data available on the potential effect of budesonide on fertility. Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure (see section 5.3).

 

Budesonide/formoterol [1], furazolidone ---> SmPC of [1] of EMA

Concomitant treatment with monoamine oxidase inhibitors including medicinal products with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions.

 

Budesonide/formoterol [1], halogenated anaesthetics ---> SmPC of [1] of EMA

There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons and formoterol.

 

Budesonide/formoterol [1], IMAOs ---> SmPC of [1] of EMA

Concomitant treatment with monoamine oxidase inhibitors including medicinal products with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions.

 

Budesonide/formoterol [1], itraconazol ---> SmPC of [1] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide/formoterol [1], ketoconazole ---> SmPC of [1] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide/formoterol [1], levodopa ---> SmPC of [1] of EMA

In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2- sympathomimetics.

 

Budesonide/formoterol [1], levothyroxine ---> SmPC of [1] of EMA

In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2- sympathomimetics.

 

Budesonide/formoterol [1], nefazodone ---> SmPC of [1] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide/formoterol [1], oxytocin ---> SmPC of [1] of EMA

In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2- sympathomimetics.

 

Budesonide/formoterol [1], phenothiazines ---> SmPC of [1] of EMA

Concomitant treatment of formoterol with phenothiazines can prolong the QTc-interval and increase the risk of ventricular arrhythmias.

 

Budesonide/formoterol [1], posaconazole ---> SmPC of [1] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide/formoterol [1], pregnancy ---> SmPC of [1] of EMA

During pregnancy, a fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate should only be used when the benefits outweigh the potential risks.

 

Budesonide/formoterol [1], procainamide ---> SmPC of [1] of EMA

Concomitant treatment of formoterol with procainamide can prolong the QTc-interval and increase the risk of ventricular arrhythmias.

 

Budesonide/formoterol [1], procarbazine ---> SmPC of [1] of EMA

Concomitant treatment with monoamine oxidase inhibitors including medicinal products with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions.

 

Budesonide/formoterol [1], protease inhibitors ---> SmPC of [1] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide/formoterol [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Caution should be observed when treating patients with prolongation of the QTc-interval. Formoterol itself may induce prolongation of the QTc-interval.

 

Budesonide/formoterol [1], quinidine ---> SmPC of [1] of EMA

Concomitant treatment of formoterol with quinidine can prolong the QTc-interval and increase the risk of ventricular arrhythmias.

 

Budesonide/formoterol [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide/formoterol [1], telithromycin ---> SmPC of [1] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

Budesonide/formoterol [1], terfenadine ---> SmPC of [1] of EMA

Concomitant treatment of formoterol with terfenadine can prolong the QTc-interval and increase the risk of ventricular arrhythmias.

 

Budesonide/formoterol [1], tricyclic antidepressant ---> SmPC of [1] of EMA

Concomitant treatment of formoterol with tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.

 

Budesonide/formoterol [1], voriconazole ---> SmPC of [1] of EMA

Potent inhibitors of CYP3A4 are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.

 

 

             CONTRAINDICATIONS of Budesonide/formoterol (BiResp Spiromax)

             - Hypersensitivity to the active substances or the excipient listed in section 6.1.

 

             https://www.ema.europa.eu/en/documents/product-information/biresp-spiromax-epar-product-information_en.pdf 24/07/2024 

 

Other trade names: Budesonide/Formoterol Teva, DuoResp Spiromax, Vylaer Spiromax, GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.),

 



          

Buflomedil

 

Ability to drive, buflomedil

Vertigo or dizziness may occur

 

Alcohol, buflomedil

The co-administration may increase the hypotensive effect

 

Amlodipine, buflomedil

The co-administration may increase the hypotensive effect

 

Antihypertensives, buflomedil

The co-administration may increase the hypotensive effect

 

Breast-feeding, buflomedil

Buflomedil should not be used during breastfeeding

 

Buflomedil, calcium antagonists

The co-administration may increase the hypotensive effect

 

Buflomedil, fluoxetine

The risk of neurological adverse effects increases if buflomedil is administered with CYP2D6 inhibitors to patients with renal or hepatic disorder

 

Buflomedil, paroxetine

The risk of neurological adverse effects increases if buflomedil is administered with CYP2D6 inhibitors to patients with renal or hepatic disorder

 

Buflomedil, pregnancy

Buflomedil should not be used during pregnancy

 

Buflomedil, quinidine

The risk of neurological adverse effects increases if buflomedil is administered with CYP2D6 inhibitors to patients with renal or hepatic disorder

 

Buflomedil, strong CYP2D6 inhibitors

The risk of neurological adverse effects increases if buflomedil is administered with CYP2D6 inhibitors to patients with renal or hepatic disorder

 

Buflomedil, vasodilators

The co-administration may increase the hypotensive effect

 

Buflomedil, verapamil

The co-administration may increase the hypotensive effect

 

CYP2D6 inhibitors, buflomedil

The risk of neurological adverse effects increases if buflomedil is administered with CYP2D6 inhibitors to patients with renal or hepatic disorder


 

 



Bulevirtide (Hepcludex)

Ability to drive, bulevirtide [2] ---> SmPC of [2] of EMA

The product has minor influence on the ability to drive and use machines. Patients should be informed that dizziness has been reported during treatment with bulevirtide.

 

Atorvastatin, bulevirtide [2] ---> SmPC of [2] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Atorvastatin, bulevirtide [2] ---> SmPC of [2] of EMA

As a precautionary measure, close clinical monitoring is warranted when NTCP substrates are co- administered with bulevirtide. When possible, co-administration of these substrates should be avoided.

 

Bosentan, bulevirtide [2] ---> SmPC of [2] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Breast-feeding, bulevirtide [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breastfeeding or to discontinue / abstain from treatment with bulevirtide, taking into account the benefit of breastfeeding for the child with regard to the benefit of treatment for the mother.

 

Bulevirtide [1], carbamazepine ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted for co-administered narrow-therapeutic-index drugs which are sensitive CYP3A4 substrates

 

Bulevirtide [1], cyclosporine ---> SmPC of [1] of EMA

In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodium- taurocholate co-transporting polypeptide (NTCP). The co-administration of such medicinal products is not recommended.

 

Bulevirtide [1], cyclosporine ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted for co-administered narrow-therapeutic-index drugs which are sensitive CYP3A4 substrates

 

Bulevirtide [1], cytochrome P450 ---> SmPC of [1] of EMA

No CYP inhibition by bulevirtide was observed in vitro at clinically relevant concentrations.

 

Bulevirtide [1], docetaxel ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted for co-administered narrow-therapeutic-index drugs which are sensitive CYP3A4 substrates

 

Bulevirtide [1], ezetimibe ---> SmPC of [1] of EMA

In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodium- taurocholate co-transporting polypeptide (NTCP). The co-administration of such medicinal products is not recommended.

 

Bulevirtide [1], fertility ---> SmPC of [1] of EMA

No human data on the effect of bulevirtide on fertility are available. In animal studies, no effects of bulevirtide on male or female mating and fertility were noted.

 

Bulevirtide [1], fexofenadine ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], fluvastatin ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted when NTCP substrates are co- administered with bulevirtide. When possible, co-administration of these substrates should be avoided.

 

Bulevirtide [1], glecaprevir ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], glibenclamide ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], grazoprevir ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], irbesartan ---> SmPC of [1] of EMA

In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodium- taurocholate co-transporting polypeptide (NTCP). The co-administration of such medicinal products is not recommended.

 

Bulevirtide [1], midazolam ---> SmPC of [1] of EMA

However, in a clinical study, an approximately 40% increase in geometric mean of partial AUC2-4h values of co-administered midazolam (CYP3A4 substrate) was observed in combination of high dose bulevirtide (10 mg) and tenofovir (245 mg)

 

Bulevirtide [1], nateglinide ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], NTCP inhibitors ---> SmPC of [1] of EMA

In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodium- taurocholate co-transporting polypeptide (NTCP). The co-administration of such medicinal products is not recommended.

 

Bulevirtide [1], NTCP substrates ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted when NTCP substrates are co- administered with bulevirtide. When possible, co-administration of these substrates should be avoided.

 

Bulevirtide [1], olmesartan ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], paclitaxel ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], pitavastatin ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted when NTCP substrates are co- administered with bulevirtide. When possible, co-administration of these substrates should be avoided.

 

Bulevirtide [1], pitavastatin ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], pravastatine ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted when NTCP substrates are co- administered with bulevirtide. When possible, co-administration of these substrates should be avoided.

 

Bulevirtide [1], pravastatine ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], pregnancy ---> SmPC of [1] of EMA

As a precautious measure, it is preferable to avoid the use of bulevirtide during pregnancy and in women of child-bearing age who do not use contraception.

 

Bulevirtide [1], repaglinide ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], ritonavir ---> SmPC of [1] of EMA

In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodium- taurocholate co-transporting polypeptide (NTCP). The co-administration of such medicinal products is not recommended.

 

Bulevirtide [1], rosuvastatin ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted when NTCP substrates are co- administered with bulevirtide. When possible, co-administration of these substrates should be avoided.

 

Bulevirtide [1], rosuvastatin ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], simeprevir ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], simvastatine ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], simvastatine ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted for co-administered narrow-therapeutic-index drugs which are sensitive CYP3A4 substrates

 

Bulevirtide [1], sirolimus ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted for co-administered narrow-therapeutic-index drugs which are sensitive CYP3A4 substrates

 

Bulevirtide [1], sulfasalazine ---> SmPC of [1] of EMA

In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodium- taurocholate co-transporting polypeptide (NTCP). The co-administration of such medicinal products is not recommended.

 

Bulevirtide [1], tacrolimus ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted for co-administered narrow-therapeutic-index drugs which are sensitive CYP3A4 substrates

 

Bulevirtide [1], telmisartan ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], tenofovir ---> SmPC of [1] of EMA

In a clinical study in healthy subjects, co-administration of tenofovir and bulevirtide revealed no impact on tenofovir pharmacokinetics.

 

Bulevirtide [1], thyroid hormones ---> SmPC of [1] of EMA

As a precautionary measure, close clinical monitoring is warranted when NTCP substrates are co- administered with bulevirtide. When possible, co-administration of these substrates should be avoided.

 

Bulevirtide [1], valsartan ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

Bulevirtide [1], voxilaprevir ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 然. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

 

 

 

            CONTRAINDICATIONS of Bulevirtide (Hepcludex)            

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  

 

https://www.ema.europa.eu/en/documents/product-information/hepcludex-epar-product-information_en.pdf 25/02/2026 





 

Bumetanide

 

Aminoglycoside antibiotics, bumetanide [2] ---> SPC of [2] of eMC

Bumetanide should be used with caution in patients already receiving nephrotoxic or ototoxic drugs.

 

Aminoglycoside antibiotics, strong diuretic agents

Ototoxic effects of aminoglycosides may be increased during the treatment with strong diuretics

 

Antihypertensives, bumetanide

Bumetanide may potentiate the effects of antihypertensive drugs.

 

Ataluren [1], bumetanide ---> SPC of [1] of EMA

Caution should be exercised when ataluren is co-administered with medicinal products that are substrates of UGT1A9, OAT1, OAT3, or OATP1B3 because of the risk of increase concentration of these medicinal products

 

Breast-feeding, bumetanide [2] ---> SPC of [2] of eMC

Since it is not known whether bumetanide is distributed into breast milk, a nursing mother should either stop breast feeding or observe the infant for any adverse effects if the drug is absolutely necessary for the mother.

 

Bumetanide [1], NSAID ---> SPC of [1] of eMC

Certain non-steroidal anti-inflammatory drugs have been shown to antagonise the action of diuretics.

 

Bumetanide [1], digital glycosides ---> SPC of [1] of eMC

Bumetanide shows a tendency to increase the excretion of potassium which can lead to an increase in the sensitivity of the myocardium to the toxic effects of digitalis.

 

Bumetanide [1], lithium ---> SPC of [1] of eMC

Bumetanide should not be administered concurrently with lithium salts. Diuretics can reduce lithium clearance resulting in high serum levels of lithium.

 

Bumetanide [1], pregnancy ---> SPC of [1] of eMC

Although tests in four animal species have shown no teratogenic effects, the ordinary precaution of avoiding use of bumetanide in the first trimester of pregnancy should at present be observed.

 

Bumetanide, cephalosporins

Bumetanide should be used with caution in patients already receiving nephrotoxic or ototoxic drugs.

 

Bumetanide, class IA antiarrhythmic agents

Hypokalaemia increases the risk of QT interval prolongation and torsades de pointes of class Ia antiarrhythmics

 

Bumetanide, class III antiarrhythmic agents

Hypokalaemia increases the risk of QT interval prolongation and torsades de pointes of class III antiarrhythmics

 

Bumetanide, diuretics

Bumetanide may potentiate the effects of antihypertensive drugs.

 

Bumetanide, hypokalemia

The hypokalaemic effect of bumetanide can be increased by other potassium-lowering drugs

 

Bumetanide, indapamide

The co-administration of indapamide with diuretics which may cause hypokalaemia is not recommended.

 

Bumetanide, milrinone [2] ---> SPC of [2] of eMC

Furosemide should not be administered in intravenous lines containing milrinone lactate in order to avoid precipitation.

 

Bumetanide, muscle relaxants (non-depolarizing)

A hypokaliemia can increase the sensitivity of the myocardium to nondepolarizing muscle relaxants

 

Bumetanide, nephrotoxic substances

Bumetanide should be used with caution in patients already receiving nephrotoxic or ototoxic drugs.

 

Bumetanide, orthostatic hypotension

Bumetanide may potentiate the effects of antihypertensive drugs.

 

Bumetanide, probenecide

Probenecid inhibits the renal tubular excretion of bumetanide and decreases the natriuresis

 

Bumetanide, tafamidis [2] ---> SPC of [2] of EMA

Tafamidis inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters

 

Bumetanide, tricyclic antidepressant

Bumetanide may potentiate the effects of antihypertensive drugs.

 

 

           CONTRAINDICATIONS of Bumetanide

            

           - Although Burinex can be used to induce diuresis in renal insufficiency, any marked increase in blood urea or the development of oliguria or anuria during treatment of severe progressing renal disease are indications for stopping treatment with Burinex.

           - Hypersensitivity to Burinex. Burinex is contraindicated in hepatic coma and care should be taken in states of severe electrolyte depletion.

           - As with other diuretics, Burinex should not be administered concurrently with lithium salts. Diuretics can reduce lithium clearance resulting in high serum levels of lithium.

            

           http://www.medicines.org.uk/emc/


 

          

Bupivacaine

 

Ability to drive, bupivacaine [2] ---> SPC of [2] of eMC

Depending on dosage, local anaesthetics may have a very mild effect on mental function and co-ordination even in the absence of overt CNS toxicity and may temporarily impair locomotion and alertness.

 

Anticoagulants, bupivacaine [2] ---> SPC of [2] of eMC

Epidural anaesthesia is contra-indicated in patients receiving anticoagulant therapy.

 

Betablockers, bupivacaine

The co-administration may have an additive inhibitor effect on AV conduction, intraventricular impulse spread and contraction force

 

Breast-feeding, bupivacaine [2] ---> SPC of [2] of eMC

Bupivacaine enters the mother's milk, but in such small quantities that there is no risk of affecting the child at therapeutic dose levels.

 

Bupivacaine [1], pregnancy ---> SPC of [1] of eMC

Bupivacaine should not be given in early pregnancy unless the benefits are considered to outweigh the risks.

 

Bupivacaine, calcium antagonists

The co-administration may have an additive inhibitor effect on AV conduction, intraventricular impulse spread and contraction force

 

Bupivacaine, central analgesics

Toxic Synergism

 

Bupivacaine, class III antiarrhythmic agents

Specific interaction studies with bupivacaine and class III anti-arrhythmic drugs (e.g. amiodarone) have not been performed, but caution is advised.

 

Bupivacaine, dextran

Increased bleeding tendency

 

Bupivacaine, ether

Toxic Synergism

 

Bupivacaine, heparin

Increased bleeding tendency

 

Bupivacaine, local anaesthetics

Bupivacaine should be used with caution in patients receiving other local anaesthetics, since the systemic toxic effects are additive.

 

Bupivacaine, mexiletine

Bupivacaine should be used with caution in patients receiving agents structurally related to amide-type local anaesthetics, e.g. certain anti-arrhythmics, such as lidocaine and mexiletine, since the systemic toxic effects are additive.

 

Bupivacaine, muscle relaxants (non-depolarizing)

Prolongation of the muscle relaxant effect

 

Bupivacaine, plasma substitutes

Increased bleeding tendency

 

Bupivacaine, sulphamides

Decreased sulfonamide effect

 

Bupivacaine, sulphonamides

Decreased sulfonamide effect

 

Bupivacaine, tocainide

Bupivacaine should be used with caution in patients receiving agents structurally related to amide-type local anaesthetics, e.g. certain anti-arrhythmics, such as lidocaine and mexiletine, since the systemic toxic effects are additive.

 

Bupivacaine, vasoconstrictors

The co-administration of local anesthetics with vasoconstrictor agents prolongs the duration of action and reduces plasma levels of local anesthetic

 

Bupivacaine, ziconotide [2] ---> SPC of [2] of EMA

An increased incidence of somnolence has been observed. The simultaneous use is discouraged.

 

Local anaesthetics, vasoconstrictors

The co-administration of local anesthetics with vasoconstrictor agents prolongs the duration of action and reduces plasma levels of local anesthetic

 

NSAID, bupivacaine

Increased bleeding tendency

 

 

           CONTRAINDICATIONS of Bupivacaine

            

           - Bupivacaine hydrochloride solutions are contra-indicated in patients with a known hypersensitivity to local anaesthetic agents of the amide group or to other components of the infusion formulation. Solutions of bupivacaine hydrochloride are contra-indicated for intravenous regional anaesthesia (Bier's block).

           - Epidural anaesthesia, regardless of the local anaesthetic used, has its own contra-indications which include: Active disease of the central nervous system such as meningitis, poliomyelitis, intracranial haemorrhage, subacute combined degeneration of the cord due to pernicious anaemia, and cerebral or spinal tumours.

           Tuberculosis of the spine. Pyogenic infection of the skin at or adjacent to the site of lumbar puncture. Spina bifida or meningomyelocele. A diagnosed arteriovenous malformation in the vertebral column in close proximity to the proposed puncture site. Cardiogenic or hypovolaemic shock. Coagulation disorders or ongoing anticoagulant therapy. Epidural and spinal anaesthesia is contra-indicated in patients with an expanding cerebral lesion, a tumour, cyst or abscess, which may, if the intracranial pressure is suddenly altered, cause obstruction to the cerebrospinal fluid or blood circulation (the pressure cone).

            

           http://www.medicines.org.uk/emc/


 


            


Bupivacaine/meloxicam (Zynrelef)

Ability to drive, bupivacaine/meloxicam [2] ---> SmPC of [2] of EMA

Zynrelef may have a very mild effect on mental function and coordination even in the absence of overt central nervous system (CNS) toxicity, and may temporarily impair locomotion and alertness.

 

ACE inhibitors, bupivacaine/meloxicam [2] ---> SmPC of [2] of EMA

NSAIDs may decrease the antihypertensive effect of ACE inhibitors, angiotensin-II antagonists, or beta-blockers (including propranolol).

 

ACE inhibitors, NSAID ---> SmPC of [Bupivacaine/meloxicam] of EMA

Co-administration of an NSAID with ACE inhibitors or angiotensin-II antagonists may result in deterioration of renal function, including possible acute renal failure

 

AIIRA, bupivacaine/meloxicam [2] ---> SmPC of [2] of EMA

NSAIDs may decrease the antihypertensive effect of ACE inhibitors, angiotensin-II antagonists, or beta-blockers (including propranolol).

 

Betablockers, bupivacaine/meloxicam [2] ---> SmPC of [2] of EMA

NSAIDs may decrease the antihypertensive effect of ACE inhibitors, angiotensin-II antagonists, or beta-blockers (including propranolol).

 

Breast-feeding, bupivacaine/meloxicam [2] ---> SmPC of [2] of EMA

A decision must be made whether to start or discontinue breast-feeding taking into account the benefit of breast- feeding for the child and the benefit of Zynrelef for the woman.

 

Bupivacaine/meloxicam [1], diuretics ---> SmPC of [1] of EMA

Patients on diuretics should be monitored following treatment with Zynrelef for signs of worsening renal function, in addition to assuring diuretic efficacy, including antihypertensive effects.

 

Bupivacaine/meloxicam [1], fertility ---> SmPC of [1] of EMA

The use of meloxicam may impair fertility in women attempting to conceive.

 

Bupivacaine/meloxicam [1], lidocaine ---> SmPC of [1] of EMA

Bupivacaine should be used with caution in patients receiving other local anaesthetics or active substances structurally related to amide-type local anaesthetics, since the systemic toxic effects are additive

 

Bupivacaine/meloxicam [1], local anaesthetics ---> SmPC of [1] of EMA

Bupivacaine should be used with caution in patients receiving other local anaesthetics or active substances structurally related to amide-type local anaesthetics, since the systemic toxic effects are additive

 

Bupivacaine/meloxicam [1], mexiletine ---> SmPC of [1] of EMA

Bupivacaine should be used with caution in patients receiving other local anaesthetics or active substances structurally related to amide-type local anaesthetics, since the systemic toxic effects are additive

 

Bupivacaine/meloxicam [1], pregnancy ---> SmPC of [1] of EMA

Due to the meloxicam content, Zynrelef is contraindicated during the third trimester of pregnancy. During the first and second trimester of pregnancy, meloxicam should not be given unless clearly necessary.

 

Bupivacaine/meloxicam [1], propranolol ---> SmPC of [1] of EMA

NSAIDs may decrease the antihypertensive effect of ACE inhibitors, angiotensin-II antagonists, or beta-blockers (including propranolol).

 

Lithium, NSAID ---> SmPC of [Bupivacaine/meloxicam] of EMA

NSAIDs have been reported to increase blood lithium levels (via decreased renal excretion of lithium), which may reach toxic values. The concomitant use of lithium and NSAIDs is not recommended.

 

 

            CONTRAINDICATIONS of Bupivacaine/meloxicam (Zynrelef)

            - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

            - Patients with a known hypersensitivity to any local amide-type anaesthetic or non-steroidal antiinflammatory drugs (NSAIDs). Meloxicam must not be given to patients who have developed signs of asthma, nasal polyps, angioneurotic oedema, or urticaria following the administration of acetyl salicylic acid or other NSAIDs.

            - Third trimester of pregnancy (see section 4.6).

            - Coronary artery bypass graft (CABG) surgery (see section 4.4).

            - Severe heart failure (see section 4.4).

            - Severely impaired liver function (see section 4.4).

            - Non-dialysed severe renal failure (see section 4.4).

             

https://www.ema.europa.eu/en/documents/product-information/zynrelef-epar-product-information_en.pdf  22/11/2023 (withdrawn) 

 



Buprenorphine (Buvidal)

5-HT3 receptor antagonists, buprenorphine ---> SmPC of [granisetron] of EMA

For serotonergic medicinal products (e.g. SSRIs and SNRIs, buprenorphine, opioids or other serotonergic medicinal products), there have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicines

 

Ability to drive, buprenorphine [2] ---> SmPC of [2] of EMA

The patient should be cautioned not to drive or operate hazardous machinery whilst taking this medicine until it is known how the patient is affected by the medicine.

 

Alcohol, buprenorphine [2] ---> SmPC of [2] of EMA

Buprenorphine should be used cautiously when co-administered with alcoholic drinks or medicinal products containing alcohol as alcohol increases the sedative effect of buprenorphine

 

Anticholinergics, buprenorphine [2] ---> SmPC of [2] of EMA

Concomitant administration of buprenorphine with anticholinergics or medications with anticholinergic activity may result in increased anticholinergic adverse effects.

 

Antihistamines, buprenorphine [2] ---> SmPC of [2] of EMA

Buprenorphine should be used cautiously when co-administered with other central nervous system depressants: These combinations increase central nervous system depression

 

Anxiolytics, buprenorphine [2] ---> SmPC of [2] of EMA

Buprenorphine should be used cautiously when co-administered with other central nervous system depressants: These combinations increase central nervous system depression

 

Atazanavir [1], buprenorphine ---> SmPC of [1] of EMA

The CYP3A4 and UGT1A1 inhibition may increase the buprenorphine plasma levels. Co-administration warrants clinical monitoring for sedation and cognitive effects.

 

Atazanavir/cobicistat [1], buprenorphine ---> SmPC of [1] of EMA

Concomitant use may increase buprenorphine exposition. The mechanism of interaction is CYP3A4 and UGT1A1 inhibition by atazanavir. Co-administration warrants clinical monitoring for sedation and cognitive effects.

 

Atazanavir/ritonavir, buprenorphine ---> SmPC of [atazanavir] of EMA

The CYP3A4 and UGT1A1 inhibition may increase the buprenorphine plasma levels. Co-administration warrants clinical monitoring for sedation and cognitive effects.

 

Azole antifungals, buprenorphine [2] ---> SmPC of [2] of EMA

CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.

 

Barbiturates, buprenorphine [2] ---> SmPC of [2] of EMA

Buprenorphine should be used cautiously when co-administered with other central nervous system depressants: These combinations increase central nervous system depression

 

Benzodiazepines, buprenorphine [2] ---> SmPC of [2] of EMA

Es ist Vorsicht geboten bei der Anwendung von Buprenorphin zusammen mit Benzodiazepinen: Diese Kombination kann eine zentrale Atemdepression auslösen, die zum Tode führt.

 

Boceprevir [1], buprenorphine/naloxone ---> SmPC of [1] of EMA

No dose adjustment of buprenorphine/naloxone or Victrelis is recommended. Patients should be monitored for signs of opiate toxicity associated with buprenorphine

 

Breast-feeding, buprenorphine [2] ---> SmPC of [2] of EMA

Buprenorphine and its metabolites are excreted in human breast milk and Buvidal should be used with caution during breast-feeding.

 

Buprenorphine [1], carbamazepine ---> SmPC of [1] of EMA

CYP3A4 inducers may induce the metabolism of buprenorphine resulting in decreased buprenorphine levels.

 

Buprenorphine [1], clonidine ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with other central nervous system depressants: These combinations increase central nervous system depression

 

Buprenorphine [1], CNS depressants ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with other central nervous system depressants: These combinations increase central nervous system depression

 

Buprenorphine [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA

CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.

 

Buprenorphine [1], drugs primarily metabolised by CYP2D6 ---> SmPC of [1] of eMC

When buprenorphine is combined with medicinal products that are CYP2D6 substrates the plasma levels of these products may be increased and the risk of dose dependent adverse reactions may occur

 

Buprenorphine [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of eMC

When buprenorphine is combined with medicinal products that are CYP3A4 substrates the plasma levels of these products may be increased and the risk of dose dependent adverse reactions may occur

 

Buprenorphine [1], fertility ---> SmPC of [1] of EMA

There are no or limited data on effects of buprenorphine on human fertility. An effect of buprenorphine on fertility in animals has not been seen (see section 5.3).

 

Buprenorphine [1], gabapentin ---> SmPC of [1] of EMA

Patients should be cautioned to use gabapentinoids (such as pregabalin and gabapentin) concurrently with this product only as directed by their physician (see section 4.4).

 

Buprenorphine [1], gabapentinoid ---> SmPC of [1] of EMA

The concomitant use of Buvidal with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death.

 

Buprenorphine [1], indinavir ---> SmPC of [1] of EMA

CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.

 

Buprenorphine [1], itraconazol ---> SmPC of [1] of EMA

CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.

 

Buprenorphine [1], ketoconazole ---> SmPC of [1] of EMA

CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.

 

Buprenorphine [1], methadone ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with other central nervous system depressants: These combinations increase central nervous system depression

 

Buprenorphine [1], nalmefene ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with naltrexone and nalmefene: These are opioid antagonists that can block the pharmacological effects of buprenorphine.

 

Buprenorphine [1], nalmefene ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with naltrexone and nalmefene: These are opioid antagonists that can block the pharmacological effects of buprenorphine.

 

Buprenorphine [1], nelfinavir ---> SmPC of [1] of EMA

CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.

 

Buprenorphine [1], neuroleptics ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with other central nervous system depressants: These combinations increase central nervous system depression

 

Buprenorphine [1], opiates ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with other central nervous system depressants: These combinations increase central nervous system depression

 

Buprenorphine [1], opioid analgesics ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with opioid analgesics: Adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine.

 

Buprenorphine [1], phenobarbital ---> SmPC of [1] of EMA

CYP3A4 inducers may induce the metabolism of buprenorphine resulting in decreased buprenorphine levels.

 

Buprenorphine [1], phenytoin ---> SmPC of [1] of EMA

CYP3A4 inducers may induce the metabolism of buprenorphine resulting in decreased buprenorphine levels.

 

Buprenorphine [1], pregabalin ---> SmPC of [1] of EMA

Patients should be cautioned to use gabapentinoids (such as pregabalin and gabapentin) concurrently with this product only as directed by their physician (see section 4.4).

 

Buprenorphine [1], pregnancy ---> SmPC of [1] of EMA

Buprenorphine should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.

 

Buprenorphine [1], pregnancy ---> SmPC of [1] of EMA

Due to the long half-life of buprenorphine, neonatal monitoring for several days after birth should be considered to prevent the risk of respiratory depression or withdrawal

 

Buprenorphine [1], protease inhibitors ---> SmPC of [1] of EMA

CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.

 

Buprenorphine [1], rifampicin ---> SmPC of [1] of EMA

CYP3A4 inducers may induce the metabolism of buprenorphine resulting in decreased buprenorphine levels.

 

Buprenorphine [1], saquinavir ---> SmPC of [1] of EMA

CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.

 

Buprenorphine [1], sedating antihistamines ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with other central nervous system depressants: These combinations increase central nervous system depression

 

Buprenorphine [1], serotonergic medicines ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with serotonergic medicinal products, as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).

 

Buprenorphine [1], SNRIs ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with serotonergic medicinal products, as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).

 

Buprenorphine [1], SSRI ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with serotonergic medicinal products, as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).

 

Buprenorphine [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

CYP3A4 inducers may induce the metabolism of buprenorphine resulting in decreased buprenorphine levels.

 

Buprenorphine [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.

 

Buprenorphine [1], tricyclic antidepressant ---> SmPC of [1] of EMA

Buprenorphine should be used cautiously when co-administered with serotonergic medicinal products, as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).

 

Buprenorphine [1], UGT1A1 inhibitors ---> SmPC of [1] of EMA

UGT1A1 inhibitors may affect the systemic exposure of buprenorphine.

 

Buprenorphine, central antitussives [2] ---> SmPC of [2] of EMA

Buprenorphine should be used cautiously when co-administered with other central nervous system depressants: These combinations increase central nervous system depression

 

Buprenorphine, emtricitabine/rilpivirine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Based on drug-drug interaction studies conducted with the components of Odefsey, no clinically significant interactions are expected when Odefsey is combined with buprenorphine

 

Buprenorphine, fentanyl [2] ---> SmPC of [2] of EMA

The concomitant use of partial opioid agonists/antagonists is not recommended. They have high affinity to opioid receptors and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients

 

Buprenorphine, gestodene

The CYP3A4 inhibition may increase the plasma concentrations of buprenorphine

 

Buprenorphine, guanfacin

The combination increases the central nervous system depression

 

Buprenorphine, hydromorphone

The co-administration may decrease the analgetic effect by competitive blocking of receptors and increase the risk of abstinence syndrome. Combination contraindicated

 

Buprenorphine, IMAOs [2] ---> SmPC of [2] of EMA

Possible exacerbation of the opioids effects, based on experience with morphine.

 

Buprenorphine, ketoconazole [2] ---> SmPC of [2] of EMA

Careful monitoring. The buprenorphine dose should be adjusted.

 

Buprenorphine, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA

No dosage adjustment necessary.

 

Buprenorphine, lurasidone [2] ---> SmPC of [2] of EMA

Latuda should be used cautiously when co-administered with other serotonergic agents, as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).

 

Buprenorphine, maraviroc [2] ---> SmPC of [2] of EMA

CELSENTRI 300 mg twice daily and buprenorphine can be co-administered without dose adjustment.

 

Buprenorphine, morphine

The co-administration is contraindicated due to the fact that the competitive receptor blockage decreases the analgetic effect with the risk of withdrawal syndrome

 

Buprenorphine, naloxone [2] ---> SmPC of [2] of EMA

When administering naloxone to patients who have received buprenorphine as an analgesic, complete analgesia may be restored However, reversal of respiratory depression caused by buprenorphine is limited.

 

Buprenorphine, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA

The increases of plasma levels of buprenorphine and its active metabolite did not lead to clinically significant pharmacodynamic changes in a population of opioid tolerant patients.

 

Buprenorphine, pethidine

The use of pethidine with opioid agonist/antagonists may decrease the analgetic efect of pethidine and cause a withdrawal syndrome

 

Buprenorphine, ritonavir [2] ---> SmPC of [2] of EMA

The increases of plasma levels of buprenorphine and its active metabolite did not lead to clinically significant pharmacodynamic changes in a population of opioid tolerant patients.

 

Buprenorphine, selpercatinib [2] ---> SmPC of [2] of EMA

Selpercatinib increased the Cmax and AUC of repaglinide (a substrate of CYP2C8) by approximately 91% and 188% respectively. Therefore, coadministration with sensitive CYP2C8 substrates should be avoided.

 

Buprenorphine, sufentanil

Decreased analgetic effects due to competitive blockade of receptors. Concomitant use is contraindicated.

 

Buprenorphine, tapentadol [2] ---> SmPC of [2] of eMC

Care should be taken when combining tapentadol with mixed mu-opioid agonist/antagonists or partial mu-opioid agonists

 

Buprenorphine, telaprevir [2] ---> SmPC of [2] of EMA

No adjustment of the buprenorphine dose is required when co-administered with telaprevir.

 

Buprenorphine, tramadol [2] ---> SmPC of [2] of eMC

Co-administration of tramadol with mixed agonist/antagonist drugs may reduce the analgesic effect of tramadol which is a pure agonist. A withdrawal syndrome may occur.

 

Buprenorphine, triacetyloleandomycin

The strong CYP3A4 inhibition may increase the plasma concentrations of buprenorphine

 

Buprenorphine, ziconotide [2] ---> SmPC of [2] of EMA

No data are available regarding the concomitant use of partial opioid agonists (e.g. buprenorphine) with ziconotide.

 

 

            CONTRAINDICATIONS of Buprenorphine (Buvidal)

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

            - Severe respiratory insufficiency

            - Severe hepatic impairment

            - Acute alcoholism or delirium tremens

 

            https://www.ema.europa.eu/en/documents/product-information/buvidal-epar-product-information_en.pdf 08/08/2024

           

Other trade names: Bunorfin, Buprenorphine Neuraxpharm, Buprex, Canur, Feliben, Norspan, Sixmo, Subutex, Transtec,  

 





Buprenorphine/naloxone (Suboxone)

Ability to drive, buprenorphine/naloxone [2] ---> SmPC of [2] of EMA

This medicinal product may cause drowsiness, dizziness, or impaired thinking, especially during treatment induction and dose adjustment.

 

Alcohol, buprenorphine/naloxone [2] ---> SmPC of [2] of EMA

Alcohol increases the sedative effect of buprenorphine. Buprenorphine should not be taken together with alcoholic drinks or medications containing alcohol

 

Anxiolytics, buprenorphine/naloxone [2] ---> SmPC of [2] of EMA

The combination increases the central nervous system depression

 

Atazanavir/cobicistat [1], buprenorphine/naloxone ---> SmPC of [1] of EMA

Concomitant use may increase buprenorphine exposition. The mechanism of interaction is CYP3A4 inhibition by cobicistat. Co-administration warrants clinical monitoring for sedation and cognitive effects.

 

Azole antifungals, buprenorphine/naloxone [2] ---> SmPC of [2] of EMA

Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors

 

Barbiturates, buprenorphine/naloxone [2] ---> SmPC of [2] of EMA

The combination increases the central nervous system depression

 

Benzodiazepines, buprenorphine/naloxone [2] ---> SmPC of [2] of EMA

This combination may result in death due to respiratory depression of central origin.

 

Benzodiazepines, opiates ---> SmPC of [buprenorphine/naloxone] of EMA

The concomitant use of opioids with sedative medicinal products such as benzodiazepines or related medicinal products increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.

 

Benzodiazepines, sedatives ---> SmPC of [buprenorphine/naloxone] of EMA

The concomitant use of opioids with sedative medicinal products such as benzodiazepines or related medicinal products increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.

 

Boceprevir [1], buprenorphine/naloxone ---> SmPC of [1] of EMA

No dose adjustment of buprenorphine/naloxone or Victrelis is recommended. Patients should be monitored for signs of opiate toxicity associated with buprenorphine

 

Breast-feeding, buprenorphine/naloxone [2] ---> SmPC of [2] of EMA

Buprenorphine and its metabolites are excreted in human milk. In rat's buprenorphine has been found to inhibit lactation. Therefore, breastfeeding should be discontinued during treatment with Suboxone.

 

Buprenorphine, naltrexone ---> SmPC of [buprenorphine/naloxone] of EMA

Naltrexone is an opioid antagonist that can block the pharmacological effects of buprenorphine.

 

Buprenorphine/naloxone [1], carbamazepine ---> SmPC of [1] of EMA

Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.

 

Buprenorphine/naloxone [1], central antitussives ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

 

Buprenorphine/naloxone [1], clonidine ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

 

Buprenorphine/naloxone [1], CNS depressants ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

 

Buprenorphine/naloxone [1], fertility ---> SmPC of [1] of EMA

Animal studies have shown a reduction in female fertility at high doses (systemic exposure > 2.4 times the human exposure at the maximum recommended dose of 24 mg buprenorphine, based on AUC, see section 5.3).

 

Buprenorphine/naloxone [1], foods ---> SmPC of [1] of EMA

The tablet is to be placed under the tongue until completely dissolved. Patients should not swallow or consume food or drink until the tablet is completely dissolved.

 

Buprenorphine/naloxone [1], full opioid agonist ---> SmPC of [1] of EMA

Therefore the potential to overdose with a full agonist exists, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining.

 

Buprenorphine/naloxone [1], gabapentin ---> SmPC of [1] of EMA

The concomitant use of Suboxone with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death (see section 4.4).

 

Buprenorphine/naloxone [1], guanfacin ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

 

Buprenorphine/naloxone [1], IMAOs ---> SmPC of [1] of EMA

The concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine.

 

Buprenorphine/naloxone [1], indinavir ---> SmPC of [1] of EMA

Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors

 

Buprenorphine/naloxone [1], itraconazol ---> SmPC of [1] of EMA

Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors

 

Buprenorphine/naloxone [1], ketoconazole ---> SmPC of [1] of EMA

An interaction study of buprenorphine with ketoconazole (a potent inhibitor of CYP3A4) resulted in increased Cmax and AUC (area under the curve) of buprenorphine (approximately 50 % and 70 % respectively) and, to a lesser extent, of norbuprenorphine.

 

Buprenorphine/naloxone [1], macrolide antibiotics ---> SmPC of [1] of EMA

Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors

 

Buprenorphine/naloxone [1], methadone ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

 

Buprenorphine/naloxone [1], methyldopa ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

 

Buprenorphine/naloxone [1], moxonidine ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

 

Buprenorphine/naloxone [1], nalmefene ---> SmPC of [1] of EMA

Naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine. Co-administration during buprenorphine/naloxone treatment is contraindicated due to the potentially dangerous interaction

 

Buprenorphine/naloxone [1], naltrexone ---> SmPC of [1] of EMA

Naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine. Co-administration during buprenorphine/naloxone treatment is contraindicated due to the potentially dangerous interaction

 

Buprenorphine/naloxone [1], nelfinavir ---> SmPC of [1] of EMA

Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors

 

Buprenorphine/naloxone [1], neuroleptics ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

 

Buprenorphine/naloxone [1], opioid analgesics ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

 

Buprenorphine/naloxone [1], phenobarbital ---> SmPC of [1] of EMA

Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.

 

Buprenorphine/naloxone [1], phenytoin ---> SmPC of [1] of EMA

Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.

 

Buprenorphine/naloxone [1], pregabalin ---> SmPC of [1] of EMA

The concomitant use of Suboxone with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death (see section 4.4).

 

Buprenorphine/naloxone [1], pregnancy ---> SmPC of [1] of EMA

Due to the long half-life of buprenorphine, neonatal monitoring for several days should be considered at the end of pregnancy, to prevent the risk of respiratory depression or withdrawal syndrome in neonates.

 

Buprenorphine/naloxone [1], pregnancy ---> SmPC of [1] of EMA

Furthermore, the use of buprenorphine/naloxone during pregnancy should be assessed by the physician. Buprenorphine/naloxone should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

 

Buprenorphine/naloxone [1], protease inhibitors ---> SmPC of [1] of EMA

Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors

 

Buprenorphine/naloxone [1], rifampicin ---> SmPC of [1] of EMA

Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.

 

Buprenorphine/naloxone [1], ritonavir ---> SmPC of [1] of EMA

Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors

 

Buprenorphine/naloxone [1], sedating antihistamines ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

 

Buprenorphine/naloxone [1], serotonergic medicines ---> SmPC of [1] of EMA

Suboxone should be used cautiously when co-administered with serotonergic medicinal products, such as MAOI, SSRIs, SNRIs or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased

 

Buprenorphine/naloxone [1], SNRIs ---> SmPC of [1] of EMA

Suboxone should be used cautiously when co-administered with serotonergic medicinal products, such as MAOI, SSRIs, SNRIs or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased

 

Buprenorphine/naloxone [1], SSRI ---> SmPC of [1] of EMA

Suboxone should be used cautiously when co-administered with serotonergic medicinal products, such as MAOI, SSRIs, SNRIs or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased

 

Buprenorphine/naloxone [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.

 

Buprenorphine/naloxone [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors

 

Buprenorphine/naloxone [1], tricyclic antidepressant ---> SmPC of [1] of EMA

Suboxone should be used cautiously when co-administered with serotonergic medicinal products, such as MAOI, SSRIs, SNRIs or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased

 

Buprenorphine/naloxone, cobicistat [2] ---> SmPC of [2] of EMA

No dosage adjustment necessary.

 

Buprenorphine/naloxone, daclatasvir [2] ---> SmPC of [2] of EMA

No dose adjustment is required

 

Buprenorphine/naloxone, darunavir/cobicistat [2] ---> SmPC of [2] of EMA

REZOLSTA may increase buprenorphine and/or norbuprenorphine plasma concentrations. Dose adjustment for buprenorphine may not be necessary when co-administered with REZOLSTA but a careful clinical monitoring for signs of opiate toxicity is recommended.

 

Buprenorphine/naloxone, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Based on theoretical considerations DRV/COBI may increase buprenorphine and/or norbuprenorphine plasma concentrations. Dose adjustment for buprenorphine may not be necessary when co-administered with Symtuza

 

Buprenorphine/naloxone, darunavir/ritonavir ---> SmPC of [darunavir] of EMA

Dose adjustment for buprenorphine may not be necessary when co-administered with darunavir/ritonavir but a careful clinical monitoring for signs of opiate toxicity is recommended.

 

Buprenorphine/naloxone, dasabuvir with ombitasvir/paritaprevir/ritonavir ---> SmPC of [dasabuvir] of EMA

CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir. No dose adjustment is necessary

 

Buprenorphine/naloxone, doravirine [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

 

Buprenorphine/naloxone, doravirine/lamivudine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

 

Buprenorphine/naloxone, efavirenz [2] ---> SmPC of [2] of EMA

Decreased exposition of buprenorphine. Dose adjustment of buprenorphine or efavirenz may not be necessary when co-administered.

 

Buprenorphine/naloxone, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

 

Buprenorphine/naloxone, elvitegravir [2] ---> SmPC of [2] of EMA

No dosage adjustment necessary.

 

Buprenorphine/naloxone, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

No dose adjustment of buprenorphine/naloxone is required.

 

Buprenorphine/naloxone, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

No dose adjustment of buprenorphine/naloxone is required.

 

Buprenorphine/naloxone, fostemsavir [2] ---> SmPC of [2] of EMA

No dose adjustment of either medicinal product is necessary.

 

Buprenorphine/naloxone, idelalisib [2] ---> SmPC of [2] of EMA

The co-administration of idelalisib with buprenorphine/naloxone may increase the serum concentrations of buprenorphine/naloxone. Careful monitoring of adverse reactions (e.g., respiratory depression, sedation) is recommended.

 

Buprenorphine/naloxone, ombitasvir/paritaprevir/ritonavir [2] ---> SmPC of [2] of EMA

CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir. No dose adjustment is necessary for buprenorphine/naloxone and Viekirax with or without dasabuvir.

 

Buprenorphine/naloxone, simeprevir [2] ---> SmPC of [2] of EMA

No clinically relevant drug-drug interaction is expected. No dose adjustment is required.

 

Buprenorphine/naloxone, tipranavir/ritonavir ---> SmPC of [tipranavir] of EMA

Decreased plasma concentrations of norbuprenorphine. Patients should be monitored for opiate withdrawal syndrome.

 

 

            CONTRAINDICATIONS of Buprenorphine/naloxone (Suboxone)

            - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

            - Severe respiratory insufficiency

            - Severe hepatic impairment

            - Acute alcoholism or delirium tremens.

            - Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence.

 

            https://www.ema.europa.eu/en/documents/product-information/suboxone-epar-product-information_en.pdf 29/07/2024

 

Other trade names: Zubsolv,  

 

   




Bupropion

 

Ability to drive, bupropion [2] ---> SPC of [2] of eMC

As with other CNS acting drugs bupropion may affect ability to perform tasks that require judgement or motor and cognitive skills. Bupropion has also been reported to cause dizziness and lightheadedness.

 

Alcohol, bupropion [2] ---> SPC of [2] of eMC

The consumption of alcohol during bupropion treatment should be minimized or avoided.

 

Amantadine, bupropion [2] ---> SPC of [2] of eMC

Limited clinical data suggest a higher incidence of undesirable effects (e.g. nausea, vomiting, and neuropsychiatric events) in patients receiving bupropion concurrently with amantadine.

 

Amifampridine [1], bupropion ---> SPC of [1] of EMA

The concomitant use of amifampridine and substances known to lower the epileptic threshold leads to an increased risk of seizures

 

Antidepressants, bupropion [2] ---> SPC of [2] of eMC

There is an increased risk of seizures occurring with the use of bupropion in the presence of predisposing risk factors which lower the seizure threshold.

 

Antimalarial agents, bupropion [2] ---> SPC of [2] of eMC

There is an increased risk of seizures occurring with the use of bupropion in the presence of predisposing risk factors which lower the seizure threshold.

 

Atomoxetine, bupropion

Seizures are a potential risk with atomoxetine. Caution is advised with concomitant use of medicinal drugs which are known to lower the seizure threshold

 

Breast-feeding, bupropion [2] ---> SPC of [2] of eMC

Bupropion and its metabolites are excreted in human breast milk. A decision on whether to abstain from breast-feeding or to abstain from therapy should be made

 

Bupropion [1], carbamazepine ---> SPC of [1] of eMC

Since bupropion is extensively metabolised, caution is advised when bupropion is co-administered with medicinal products known to induce metabolism, as these may affect its clinical efficacy and safety.

 

Bupropion [1], clopidogrel ---> SPC of [1] of eMC

Co-administration of medicinal products that may affect the metabolism of bupropion via CYP2B6 isoenzyme may result in increased bupropion plasma levels and lower levels of active metabolite hydroxy-bupropion.

 

Bupropion [1], cyclophosphamide ---> SPC of [1] of eMC

Co-administration of medicinal products that may affect the metabolism of bupropion via CYP2B6 isoenzyme may result in increased bupropion plasma levels and lower levels of active metabolite hydroxy-bupropion.

 

Bupropion [1], desipramine ---> SPC of [1] of eMC

Concomitant therapy of bupropion with medicinal products with narrow therapeutic indices that are mainly metabolised by CYP2D6 (bupropion inhibits CYP2D6) should be initiated at the lower end of the dose range of the concomitant medicine.

 

Bupropion [1], drugs primarily metabolised by CYP2D6 ---> SPC of [1] of eMC

Bupropion and its main metabolite, hydroxybupropion, inhibit the CYP2D6 pathway. Concomitant therapy of bupropion with medicinal products that are mainly metabolised by CYP2D6 may increase the exposition of these medicinal products

 

Bupropion [1], drugs primarily metabolised by CYP2D6 with narrow therapeutic index ---> SPC of [1] of eMC

Concomitant therapy of bupropion with medicinal products with narrow therapeutic indices that are mainly metabolised by CYP2D6 (bupropion inhibits CYP2D6) should be initiated at the lower end of the dose range of the concomitant medicine.

 

Bupropion [1], efavirenz ---> SPC of [1] of eMC

Since bupropion is extensively metabolised, caution is advised when bupropion is co-administered with medicinal products known to induce metabolism, as these may affect its clinical efficacy and safety.

 

Bupropion [1], enzyme inductors ---> SPC of [1] of eMC

Since bupropion is extensively metabolised, caution is advised when bupropion is co-administered with medicinal products known to induce metabolism, as these may affect its clinical efficacy and safety.

 

Bupropion [1], enzyme inhibitors ---> SPC of [1] of eMC

Since bupropion is extensively metabolised, caution is advised when bupropion is co-administered with medicinal products known to inhibit metabolism, as these may affect its clinical efficacy and safety.

 

Bupropion [1], flecainide ---> SPC of [1] of eMC

Concomitant therapy of bupropion with medicinal products with narrow therapeutic indices that are mainly metabolised by CYP2D6 (bupropion inhibits CYP2D6) should be initiated at the lower end of the dose range of the concomitant medicine.

 

Bupropion [1], ifosfamide ---> SPC of [1] of eMC

Co-administration of medicinal products that may affect the metabolism of bupropion via CYP2B6 isoenzyme may result in increased bupropion plasma levels and lower levels of active metabolite hydroxy-bupropion.

 

Bupropion [1], imipramine ---> SPC of [1] of eMC

Concomitant therapy of bupropion with medicinal products with narrow therapeutic indices that are mainly metabolised by CYP2D6 (bupropion inhibits CYP2D6) should be initiated at the lower end of the dose range of the concomitant medicine.

 

Bupropion [1], levodopa ---> SPC of [1] of eMC

Limited clinical data suggest a higher incidence of undesirable effects (e.g. nausea, vomiting, and neuropsychiatric events) in patients receiving bupropion concurrently with levodopa.

 

Bupropion [1], metoprolol ---> SPC of [1] of eMC

Concomitant therapy of bupropion with medicinal products with narrow therapeutic indices that are mainly metabolised by CYP2D6 (bupropion inhibits CYP2D6) should be initiated at the lower end of the dose range of the concomitant medicine.

 

Bupropion [1], neuroleptics ---> SPC of [1] of eMC

There is an increased risk of seizures occurring with the use of bupropion in the presence of predisposing risk factors which lower the seizure threshold.

 

Bupropion [1], orphenadrine ---> SPC of [1] of eMC

Co-administration of medicinal products that may affect the metabolism of bupropion via CYP2B6 isoenzyme may result in increased bupropion plasma levels and lower levels of active metabolite hydroxy-bupropion.

 

Bupropion [1], phenytoin ---> SPC of [1] of eMC

Since bupropion is extensively metabolised, caution is advised when bupropion is co-administered with medicinal products known to induce metabolism, as these may affect its clinical efficacy and safety.

 

Bupropion [1], pregnancy ---> SPC of [1] of eMC

Bupropion should not be used in pregnancy. Pregnant women should be encouraged to quit smoking without the use of pharmacotherapy.

 

Bupropion [1], propafenone ---> SPC of [1] of eMC

Concomitant therapy of bupropion with medicinal products with narrow therapeutic indices that are mainly metabolised by CYP2D6 (bupropion inhibits CYP2D6) should be initiated at the lower end of the dose range of the concomitant medicine.

 

Bupropion [1], quinolones ---> SPC of [1] of eMC

There is an increased risk of seizures occurring with the use of bupropion in the presence of predisposing risk factors which lower the seizure threshold.

 

Bupropion [1], risperidone ---> SPC of [1] of eMC

Concomitant therapy of bupropion with medicinal products with narrow therapeutic indices that are mainly metabolised by CYP2D6 (bupropion inhibits CYP2D6) should be initiated at the lower end of the dose range of the concomitant medicine.

 

Bupropion [1], sedating antihistamines ---> SPC of [1] of eMC

There is an increased risk of seizures occurring with the use of bupropion in the presence of predisposing risk factors which lower the seizure threshold.

 

Bupropion [1], seizure-threshold lowering drugs ---> SPC of [1] of eMC

There is an increased risk of seizures occurring with the use of bupropion in the presence of predisposing risk factors which lower the seizure threshold.

 

Bupropion [1], systemic steroids ---> SPC of [1] of eMC

There is an increased risk of seizures occurring with the use of bupropion in the presence of predisposing risk factors which lower the seizure threshold.

 

Bupropion [1], theophylline ---> SPC of [1] of eMC

There is an increased risk of seizures occurring with the use of bupropion in the presence of predisposing risk factors which lower the seizure threshold.

 

Bupropion [1], thioridazine ---> SPC of [1] of eMC

Concomitant therapy of bupropion with medicinal products with narrow therapeutic indices that are mainly metabolised by CYP2D6 (bupropion inhibits CYP2D6) should be initiated at the lower end of the dose range of the concomitant medicine.

 

Bupropion [1], ticlopidine ---> SPC of [1] of eMC

Co-administration of medicinal products that may affect the metabolism of bupropion via CYP2B6 isoenzyme may result in increased bupropion plasma levels and lower levels of active metabolite hydroxy-bupropion.

 

Bupropion [1], valproate ---> SPC of [1] of eMC

Since bupropion is extensively metabolised, caution is advised when bupropion is co-administered with medicinal products known to inhibit metabolism, as these may affect its clinical efficacy and safety.

 

Bupropion, chloroquine

Bupropion may increase the risk of convulsions

 

Bupropion, citalopram

Caution is advised when concomitantly using citalopram with other medicinal products capable of lowering the seizure threshold

 

Bupropion, crizotinib [2] ---> SPC of [2] of EMA

In vitro studies indicated that crizotinib is an inhibitor of CYP2B6. Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are metabolized by CYP2B6

 

Bupropion, cyclosporine

Bupropion may decrease the therapeutic effect of cyclosporine.

 

Bupropion, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA

CYP2B6 induction. Increases in bupropion dosage should be guided by clinical response, but the maximum recommended dose of bupropion should not be exceeded. No dose adjustment is necessary for efavirenz.

 

Bupropion, eliglustat [2] ---> SPC of [2] of EMA

A dose of eliglustat 84 mg once daily should be considered when a strong CYP2D6 inhibitor is used concomitantly in intermediate and extensive metabolisers

 

Bupropion, escitalopram [2] ---> SPC of [2] of eMC

SSRIs can lower the seizure threshold. Caution is advised when concomitantly using other medicinal products capable of lowering the seizure threshold

 

Bupropion, ibrutinib [2] ---> SPC of [2] of EMA

The exposure to substrates of CYP2B6 (such as efavirenz and bupropion) and of co-regulated enzymes may be reduced upon co-administration with ibrutinib.

 

Bupropion, ioflupane [2] ---> SPC of [2] of EMA

Ioflupane binds to the dopamine transporter. Medicines that bind to the dopamine transporter with high affinity may therefore interfere with ioflupane diagnosis.

 

Bupropion, isavuconazole [2] ---> SPC of [2] of EMA

No CRESEMBA dose adjustment necessary. Bupropion: dose increase if required.

 

Bupropion, lamotrigine [2] ---> SPC of [2] of eMC

Multiple oral doses of bupropion had no statistically significant effects on the single dose pharmacokinetics of lamotrigine in 12 subjects and had only a slight increase in the AUC of lamotrigine glucuronide.

 

Bupropion, lesinurad [2] ---> SPC of [2] of EMA

Lesinurad may be a mild inducer of CYP2B6. Therefore, it is recommended that patients are monitored for reduced efficacy of CYP2B6 substrates (e.g. bupropion, efavirenz) when co-administered with Zurampic.

 

Bupropion, lopinavir/ritonavir [2] ---> SPC of [2] of EMA

Decreased plasma concentrations of bupropion and hydroxybupropion

 

Bupropion, lumacaftor/ivacaftor [2] ---> SPC of [2] of EMA

A higher dose of bupropion may be required to obtain the desired clinical effect. Lumacaftor/ivacaftor may decrease the exposure of bupropion, which may reduce its efficacy. Due to induction of CYP2B6 by lumacaftor

 

Bupropion, mefloquine

Concomitant administration of mefloquine and drugs known to lower the epileptogenic threshold may increase the risk of convulsions

 

Bupropion, mequitazine

Mequitazine should not be used with CYP2D6 inhibitor drugs. The increased plasma levels of mequitazine may increase the risk of QT interval prolongation

 

Bupropion, methylthioninium [2] ---> SPC of [2] of EMA

Methylthioninium should be avoided with medicinal products that enhance serotonergic transmission

 

Bupropion, methylthioninium chloride

Methylthioninium chloride should be avoided in patients receiving medicinal products that enhance serotonergic transmission

 

Bupropion, nebivolol [2] ---> SPC of [2] of eMC

The CYP2D6 inhibition may lead to increased plasma levels of nebivolol (metabolized by CYP2D6) that is associated with an increased risk of excessive bradycardia and adverse events.

 

Bupropion, nevirapine

The CYP3A and CYP2B6 inductions may decrease the plasma levels of bupropion

 

Bupropion, nicotine

Nicotine, administered transdermally by patches, may increase the blood pressure

 

Bupropion, ospemifene [2] ---> SPC of [2] of EMA

Ospemifene did not cause a clinically meaningful change in the exposure to the CYP2B6 substrates, indicating that ospemifene does not affect those enzyme activities in vivo to a clinically significant extent.

 

Bupropion, pitolisant [2] ---> SPC of [2] of EMA

Given the 2-fold increase of pitolisant exposure, its coadministration with CYP2D6 inhibitors should be done with caution. A dosage adjustment during the combination could eventually be considered.

 

Bupropion, ranolazine [2] ---> SPC of [2] of EMA

The potential for inhibition of CYP2B6 has not been evaluated. Caution is advised during co-administration with CYP2B6 substrates

 

Bupropion, ritonavir [2] ---> SPC of [2] of EMA

Bupropion is primarily metabolised by CYP2B6. Concurrent administration of bupropion with repeated doses of ritonavir is expected to decrease bupropion levels.

 

Bupropion, tamoxifen [2] ---> SPC of [2] of eMC

Concomitant medications that inhibit CYP2D6 may lead to reduced concentrations of the active metabolite endoxifen. Therefore, potent inhibitors of CYP2D6 should whenever possible be avoided during tamoxifen treatment

 

Bupropion, telotristat ethyl [2] ---> SPC of [2] of EMA

Concomitant use of Xermelo may decrease the efficacy of medicinal products that are CYP2B6 substrates (e.g. valproic acid, bupropion, sertraline) by decreasing their systemic exposure.

 

Bupropion, thiotepa [2] ---> SPC of [2] of EMA

Thiotepa, weak inhibitor for CYP2B6, may increase plasma concentrations of substances metabolised by CYP2B6

 

Bupropion, tipranavir/ritonavir ---> SPC of [tipranavir] of EMA

Decreased plasma concentrations of bupropion (induction of CYP2B6 and UGT activity by ritonavir)

 

Bupropion, tramadol [2] ---> SPC of [2] of eMC

Tramadol can induce convulsions and increase the potential of other seizure threshold-lowering medicinal products to cause convulsions.

 

Bupropion, tranylcypromine

Tranylcypromine should not be used concomitantly with bupropion (it has been reported about pronounced hypertension)

 

Bupropion, varenicline [2] ---> SPC of [2] of EMA

Varenicline did not alter the steady-state pharmacokinetics of bupropion.

 

Bupropion, vortioxetine [2] ---> SPC of [2] of EMA

Caution is advised when co-administrating medicines capable of lowering the seizure threshold. The strong CYP2D6 inhibition may increase plasma concentrations of vortioxetine

 

CYP2B6 inhibitors, bupropion [2] ---> SPC of [2] of eMC

Co-administration of medicinal products that may affect the metabolism of bupropion via CYP2B6 isoenzyme may result in increased bupropion plasma levels and lower levels of active metabolite hydroxy-bupropion.

 

IMAOs, bupropion [2] ---> SPC of [2] of eMC

Since MAO A and B inhibitors also enhance the catecholaminergic pathways, by a different mechanism from bupropion, concomitant use is contraindicated as there is an increased possibility of adverse reactions from their co-administration.

 

SSRI, bupropion [2] ---> SPC of [2] of eMC

There is an increased risk of seizures occurring with the use of bupropion in the presence of predisposing risk factors which lower the seizure threshold.

 

 

           CONTRAINDICATIONS of Bupropion

            

           - Zyban is contraindicated in patients with hypersensitivity to bupropion or any of the excipients

           - Zyban is contraindicated in patients with a current seizure disorder or any history of seizures.

           - Zyban is contraindicated in patients with a known central nervous system (CNS) tumour.

           - Zyban is contraindicated in patients who, at any time during treatment, are undergoing abrupt withdrawal from alcohol or any medicinal product known to be associated with risk of seizures on withdrawal (in particular benzodiazepines and benzodiazepine-like agents).

           - Zyban is contraindicated in patients with a current or previous diagnosis of bulimia or anorexia nervosa.

           - Zyban is contraindicated for use in patients with severe hepatic cirrhosis.

           - Concomitant use of Zyban and monoamine oxidase inhibitors (MAOIs) is contraindicated. At least 14 days should elapse between discontinuation of irreversible MAOIs and initiation of treatment with Zyban. For reversible MAOIs, a 24 hour period is sufficient.

           - Zyban is contraindicated in patients with a history of bipolar disorder as it may precipitate a manic episode during the depressed phase of their illness.

           - Zyban should not be administered to patients being treated with any other medicinal product containing bupropion as the incidence of seizures is dose dependent and to avoid overdosage.

            

           http://www.medicines.org.uk/emc/





Burosumab (Crysvita)

Ability to drive, burosumab [2] ---> SmPC of [2] of EMA

Burosumab may have a minor influence on the ability to drive and use machines. Dizziness may occur following administration of burosumab.

 

Breast-feeding, burosumab [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from burosumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

 

Burosumab [1], calcimimetic medicinal product ---> SmPC of [1] of EMA

Caution should be exercised when combining burosumab with calcimimetic medicinal products (i.e. agents that mimic the effect of calcium on tissues by activating the calcium receptor).

 

Burosumab [1], fertility ---> SmPC of [1] of EMA

Studies in animals have shown effects on male reproductive organs (see section 5.3). There are no clinical data available on the effect of burosumab on human fertility. No specific fertility studies in animals with burosumab were conducted.

 

Burosumab [1], phosphates ---> SmPC of [1] of EMA

Concurrent administration of burosumab with oral phosphate and vitamin D analogues is contraindicated as it may cause an increased risk of hyperphosphatemia and hypercalcaemia

 

Burosumab [1], pregnancy ---> SmPC of [1] of EMA

Burosumab is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

Burosumab [1], vitamin D ---> SmPC of [1] of EMA

Concurrent administration of burosumab with oral phosphate and vitamin D analogues is contraindicated as it may cause an increased risk of hyperphosphatemia and hypercalcaemia

 

Burosumab [1], vitamin D and analogues ---> SmPC of [1] of EMA

Concurrent administration of burosumab with oral phosphate and vitamin D analogues is contraindicated as it may cause an increased risk of hyperphosphatemia and hypercalcaemia

 

 

             CONTRAINDICATIONS of Burosumab (Crysvita)            

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Concurrent administration with oral phosphate, vitamin D analogues (see section 4.5)

             - Fasting serum phosphate above the normal range for age due to the risk of hyperphosphatemia (see section 4.4).

             - Patients with severe renal impairment or end stage renal disease.

              

             https://www.ema.europa.eu/en/documents/product-information/crysvita-epar-product-information_en.pdf  24/11/2025 



 

 


          

Buserelin

 

Ability to drive, buserelin [2] –––> SPC of [2] of eMC

Certain adverse effects (e.g. dizziness) may impair the ability to concentrate and react

 

Breast–feeding, buserelin [2] –––> SPC of [2] of eMC

It is recommended that breast–feeding be avoided during treatment

 

Buserelin [1], insulin –––> SPC of [1] of eMC

In some patients treated with GnRH–agonists, change in glucose tolerance is observed. In diabetic patients blood glucose levels must be checked regularly (risk of deterioration of metabolic control).

 

Buserelin [1], oral antidiabetics –––> SPC of [1] of eMC

In some patients treated with GnRH–agonists, change in glucose tolerance is observed. In diabetic patients blood glucose levels must be checked regularly (risk of deterioration of metabolic control).

 

Buserelin [1], pregnancy –––> SPC of [1] of eMC

It is contraindicated in pregnancy.

 

Buserelin [1], sulfonylureas –––> SPC of [1] of eMC

In some patients treated with GnRH–agonists, change in glucose tolerance is observed. In diabetic patients blood glucose levels must be checked regularly (risk of deterioration of metabolic control).

 

Buserelin, gonadotropins

The combination of gonadotropins and buserelin increases the risk of ovarian hyperstimulation syndrome

 

LH–RH agonists, antidiabetics –––> SPC of [buserelin] of eMC

In some patients treated with GnRH–agonists, change in glucose tolerance is observed. In diabetic patients blood glucose levels must be checked regularly (risk of deterioration of metabolic control).

 

 

           CONTRAINDICATIONS of Buserelin

            

           – Buserelin should not be used if the tumour is found to be insensitive to hormone manipulation or after surgical removal of the testes.

           – It is contraindicated in cases of known hypersensitivity to LHRH, buserelin or any of the excipients. It should not be used during pregnancy or lactation

           – Because of the content of benzyl alcohol Suprefact Injection must not be given to newborns or premature neonates.

            

           http://www.medicines.org.uk/emc/


 

 

Buspirone

 

Ability to drive, buspirone [2] ---> SPC of [2] of eMC

Buspirone has moderate influence on the ability to drive and use machines. Attention is drawn to the risks associated with drowsiness or dizziness induced by this drug

 

Alcohol, buspirone

Alcohol consumption should be avoided

 

Antihistamines, buspirone

Antihistamines may enhance any sedative effect.

 

Anxiolytics, buspirone [2] ---> SPC of [2] of eMC

The concomitant use of buspirone with other CNS-active drugs should be approached with caution.

 

Atazanavir/cobicistat [1], buspirone ---> SPC of [1] of EMA

Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.

 

Baclofen, buspirone

Baclofen may enhance any sedative effect.

 

Benperidol, buspirone

Buspirone may cause an increase in the plasma concentration of benperidol necessitating a dose modification.

 

Benzodiazepines, buspirone [2] ---> SPC of [2] of eMC

The concomitant use of buspirone with other CNS-active drugs should be approached with caution.

 

Breast-feeding, buspirone [2] ---> SPC of [2] of eMC

Buspirone is contraindicated in lactation

 

Bromperidol, buspirone

The co-administration may increase the plasma levels of bromperidol

 

Buspirone [1], cimetidine ---> SPC of [1] of eMC

The concomitant use of buspirone and cimetidine has shown a slight increase in the 1-(2-pyrimidinyl)-piperazine metabolite of buspirone.

 

Buspirone [1], clarithromycin ---> SPC of [1] of eMC

If buspirone is administered with a potent CYP3A4 inhibitor, the initial dose should be lowered and only increased gradually after medical evaluation

 

Buspirone [1], clotrimazole ---> SPC of [1] of eMC

If buspirone is administered with a potent CYP3A4 inhibitor, the initial dose should be lowered and only increased gradually after medical evaluation

 

Buspirone [1], diazepam ---> SPC of [1] of eMC

After addition of buspirone to the diazepam dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (Cmax , AUC, and C min ) were observed for diazepam

 

Buspirone [1], digoxin ---> SPC of [1] of eMC

Buspirone may displace digoxin from its plasma protein binding

 

Buspirone [1], diltiazem ---> SPC of [1] of eMC

Concomitant administration of buspirone and a CYP3A4 inhibitor increased the plasma concentrations of buspirone. A low dose of buspirone is recommended.

 

Buspirone [1], erythromycin ---> SPC of [1] of eMC

Concomitant administration of buspirone and a CYP3A4 inhibitor increased the plasma concentrations of buspirone. A low dose of buspirone is recommended.

 

Buspirone [1], foods ---> SPC of [1] of eMC

Food increases the bioavailability of buspirone. Buspirone should be taken at the same time each day and consistently with or without food.

 

Buspirone [1], haloperidol ---> SPC of [1] of eMC

Concomitant administration of haloperidol and buspirone can increase haloperidol serum levels.

 

Buspirone [1], itraconazol ---> SPC of [1] of eMC

If buspirone is administered with a potent CYP3A4 inhibitor, the initial dose should be lowered and only increased gradually after medical evaluation

 

Buspirone [1], moderate CYP3A4 inhibitors ---> SPC of [1] of eMC

Concomitant administration of buspirone and a CYP3A4 inhibitor increased the plasma concentrations of buspirone. A low dose of buspirone is recommended.

 

Buspirone [1], nefazodone ---> SPC of [1] of eMC

Concomitant administration of buspirone and a CYP3A4 inhibitor increased the plasma concentrations of buspirone. A low dose of buspirone is recommended.

 

Buspirone [1], pregnancy ---> SPC of [1] of eMC

Buspirone is contraindicated in pregnancy

 

Buspirone [1], sedatives ---> SPC of [1] of eMC

The concomitant use of buspirone with other CNS-active drugs should be approached with caution.

 

Buspirone [1], strong CYP3A4 inhibitors ---> SPC of [1] of eMC

If buspirone is administered with a potent CYP3A4 inhibitor, the initial dose should be lowered and only increased gradually after medical evaluation

 

Buspirone [1], trazodone ---> SPC of [1] of eMC

Concomitant administration of buspirone and trazodone showed a 3-6 fold increase of ALT in some patients.

 

Buspirone, carbamazepine

When used buspirone in combination with a potent inducer of CYP3A4, an adjustment of the dosage of buspirone may be necessary to maintain buspirone's anxiolytic effect.

 

Buspirone, chlorprothixene

The enzymatic inhibition increases the plasma levels of chlorprothixene

 

Buspirone, citalopram [2] ---> SPC of [2] of eMC

At the pharmacodynamic level cases of serotonin syndrome with citalopram and buspirone have been reported.

 

Buspirone, cobicistat [2] ---> SPC of [2] of EMA

Concentrations of this sedative/hypnotic may be increased when co-administered with cobicistat.

 

Buspirone, darunavir/cobicistat [2] ---> SPC of [2] of EMA

REZOLSTA is expected to increase the sedative/hypnotic plasma concentrations. (CYP3A inhibition). Clinical monitoring is recommended when co-administering REZOLSTA with this sedative/hypnotic and a lower dose of the sedative/hypnotic should be considered

 

Buspirone, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA

Based on theoretical considerations DRV/COBI is expected to increase this sedative/hypnotic plasma concentrations. CYP3A inhibition

 

Buspirone, darunavir/ritonavir ---> SPC of [darunavir] of EMA

Sedative/hypnotics are extensively metabolised by CYP3A. Co-administration with boosted darunavir may cause a large increase in the concentration of these medicines.

 

Buspirone, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA

Concentrations of other benzodiazepines, including diazepam, may be increased when administered with Genvoya. With other sedatives/hypnotics, dose reduction may be necessary and concentration monitoring is recommended.

 

Buspirone, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA

The co-administration may increase the plasma concentrations of sedative. Dose reduction may be necessary and concentration monitoring is recommended.

 

Buspirone, fluvoxamine

In short-term treatment with fluvoxamine and buspirone doubled buspirone plasma concentrations are observed

 

Buspirone, grapefruit juice

Grapefruit juice increases the plasma concentrations of buspirone. Patients taking buspirone should avoid consuming large quantities of grapefruit juice.

 

Buspirone, idelalisib [2] ---> SPC of [2] of EMA

The co-administration of idelalisib with buspirone may increase the serum concentrations of buspirone. Concentration monitoring of buspirone is recommended and dose reduction may be considered.

 

Buspirone, indinavir/ritonavir ---> SPC of [indinavir] of EMA

Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of buspirone. Careful monitoring of therapeutic and adverse effects is recommended

 

Buspirone, ketoconazole [2] ---> SPC of [2] of EMA

Potential increased in plasma concentrations of buspirone. Careful monitoring. Dose adjustement of buspirone may be required.

 

Buspirone, linezolid [2] ---> SPC of [2] of eMC

The co-administration is contraindicated, unless there are facilities available for close observation and monitoring of blood pressure

 

Buspirone, lithium

Caution should be exercised when buspirone is combined with serotoninergic drugs because there are reports about serotoninergic syndrome

 

Buspirone, lofexidine

Lofexidine may enhance any sedative effect.

 

Buspirone, methylthioninium [2] ---> SPC of [2] of EMA

Methylthioninium should be avoided with medicinal products that enhance serotonergic transmission

 

Buspirone, methylthioninium chloride

Methylthioninium chloride should be avoided in patients receiving medicinal products that enhance serotonergic transmission

 

Buspirone, modafinil [2] ---> SPC of [2] of eMC

Modafinil, CYP3A4 inductor, may decrease the plasma concentrations of buspirone

 

Buspirone, nabilone

Nabilone may enhance any sedative effect.

 

Buspirone, neuroleptics

The concomitant use of buspirone with other CNS-active drugs should be approached with caution.

 

Buspirone, phenelzine

Phenelzine should not be administered at the same time as, or within 14 days of, treatment with buspirone

 

Buspirone, phenobarbital

When used buspirone in combination with a potent inducer of CYP3A4, an adjustment of the dosage of buspirone may be necessary to maintain buspirone's anxiolytic effect.

 

Buspirone, phenylephrine

Buspirone could inhibit the vasopressive action of phenylephrine.

 

Buspirone, phenytoin

When used buspirone in combination with a potent inducer of CYP3A4, an adjustment of the dosage of buspirone may be necessary to maintain buspirone's anxiolytic effect.

 

Buspirone, rifampicin

When used buspirone in combination with a potent inducer of CYP3A4, an adjustment of the dosage of buspirone may be necessary to maintain buspirone's anxiolytic effect.

 

Buspirone, ritonavir [2] ---> SPC of [2] of EMA

Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of buspirone.

 

Buspirone, serotonergic medicines

Caution should be exercised when buspirone is combined with serotoninergic drugs because there are reports about serotoninergic syndrome

 

Buspirone, strong CYP3A4 inductors

When used buspirone in combination with a potent inducer of CYP3A4, an adjustment of the dosage of buspirone may be necessary to maintain buspirone's anxiolytic effect.

 

Buspirone, tramadol

Caution should be exercised when buspirone is combined with serotoninergic drugs because there are reports about serotoninergic syndrome

 

Buspirone, trandolapril/verapamil [2] ---> SPC of [2] of eMC

Verapamil may increase the plasma concentrations of buspirone thus increasing risk of toxicity

 

Buspirone, triptans

Caution should be exercised when buspirone is combined with serotoninergic drugs because there are reports about serotoninergic syndrome

 

Buspirone, verapamil [2] ---> SPC of [2] of eMC

Concomitant administration of buspirone and a CYP3A4 inhibitor increased the plasma concentrations of buspirone. A low dose of buspirone is recommended.

 

Buspirone, warfarin

Reports of increased prothrombin time have been received in patients treated with buspirone and warfarin

 

CNS depressants, buspirone

The sedative effect of buspirone can be enhanced when co-administered with CNS depressants

 

IMAOs, buspirone [2] ---> SPC of [2] of eMC

Co-administration of MAO inhibitors may cause increases in blood pressure. Co-administration of MAO inhibitors and buspirone is therefore not recommended

 

SSRI, buspirone [2] ---> SPC of [2] of eMC

The combination of buspirone and selective serotonin reuptake inhibitors (SSRI) was tested in a number of clinical trials. Although no severe toxicities were observed, there were rare cases of seizures

 

St. John's wort, buspirone

When used buspirone in combination with a potent inducer of CYP3A4, an adjustment of the dosage of buspirone may be necessary to maintain buspirone's anxiolytic effect.

 

 

           CONTRAINDICATIONS of Buspirone

            

           Buspirone is contraindicated in the following groups of patients.

           - patients with known hypersensitivity to buspirone hydrochloride or any ingredient

           - patients with epilepsy.

           - acute intoxication with alcohol, hypnotics, analgesics, or antipsychotic drugs.

           - patients with severe renal or hepatic impairment. Severe renal impairment can be defined as a creatinine clearance of 20 ml/min or below, or a plasma creatinine above 200 µmol/l.

            

           http://www.medicines.org.uk/emc/


 

 


Busulfan (Busilvex)

Breast-feeding, busulfan [2] ---> SmPC of [2] of EMA

Because of the potential for tumorigenicity shown for busulfan in human and animal studies, breast-feeding should be discontinued during treatment with busulfan.

 

Busulfan [1], cyclophosphamide ---> SmPC of [1] of EMA

In adults, for the BuCy2 regimen it has been reported that the time interval between the last oral busulfan administration and the first cyclophosphamide administration may influence the development of toxicities.

 

Busulfan [1], diazepam ---> SmPC of [1] of EMA

No interaction has been reported when benzodiazepines such as diazepam, clonazepam or lorazepam have been used to prevent seizures with high-dose busulfan.

 

Busulfan [1], fertility ---> SmPC of [1] of EMA

Busulfan and DMA can impair fertility in man or woman.

 

Busulfan [1], fertility ---> SmPC of [1] of EMA

It is advised not to father child during the treatment and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility

 

Busulfan [1], fluconazole ---> SmPC of [1] of EMA

No interaction was observed when busulfan was combined with fluconazole (antifungal agent)

 

Busulfan [1], fludarabine ---> SmPC of [1] of EMA

There is no common metabolism pathway between busulfan and fludarabine.

 

Busulfan [1], granisetron ---> SmPC of [1] of EMA

No interaction was observed when busulfan was combined with 5 HT3 antiemetics such as ondansetron or granisetron.

 

Busulfan [1], itraconazol ---> SmPC of [1] of EMA

The administration of itraconazole to patients receiving high-dose busulfan may result in reduced busulfan clearance.

 

Busulfan [1], ketobemidone ---> SmPC of [1] of EMA

Published studies in adults described that ketobemidone (analgesic) might be associated with high levels of plasma busulfan.

 

Busulfan [1], ondansetron ---> SmPC of [1] of EMA

No interaction was observed when busulfan was combined with 5 HT3 antiemetics such as ondansetron or granisetron.

 

Busulfan [1], paracetamol ---> SmPC of [1] of EMA

Paracetamol decreases glutathione levels in blood and tissues, and may decrease busulfan clearance when used in combination

 

Busulfan [1], phenytoin ---> SmPC of [1] of EMA

The concomitant systemic administration of phenytoin to patients receiving high-dose of oral busulfan has been reported to increase busulfan clearance, due to induction of glutathion-S-transferase

 

Busulfan [1], pregnancy ---> SmPC of [1] of EMA

Busulfan is contraindicated in pregnancy

 

Busulfan [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential Women of childbearing potential have to use effective contraception during and up to 6 months after treatment.

 

Busulfan, deferasirox [2] ---> SmPC of [2] of EMA

Increases in busulfan exposure have been observed at concomitant administration of busulfan and deferasirox. The mechanism behind the interaction is not fully elucidated.

 

Busulfan, glutathione-S-transferase inductor

The induction of glutathione-S-transferase decreases the busulfan plasma levels

 

Busulfan, ketoconazole [2] ---> SmPC of [2] of EMA

Potential increase in plasma concentrations of busulfan. Careful monitoring. Dose adjustment may be required.

 

Busulfan, macrosalb

Toxicological interactions may occur

 

Busulfan, melphalan [2] ---> SmPC of [2] of EMA

In the paediatric population, for the busulfan-melphalan regimen it has been reported that the administration of melphalan less than 24 hours after the last oral busulfan administration may influence the development of toxicities.

 

Busulfan, metronidazole [2] ---> SmPC of [2] of EMA

Patients who are concurrently treated with busulfan and itraconazole or metronidazole should be closely monitored for signs of busulfan toxicity.

 

Busulfan, miconazole

The strong CYP3A4 inhibition may increase the plasma concentrations of busulfan. Caution is recommended

 

Busulfan, thioguanine

The co-administration may develop nodular regenerative hyperplasia, portal hypertension and esophageal varices

 

Busulfan, thiotepa [2] ---> SmPC of [2] of EMA

The concomitant use of thiotepa and other myelosuppressive or myelotoxic agents may potentiate the risk of haematologic adverse reactions due to overlapping toxicity profiles of these medicinal products.

 

 

             CONTRAINDICATIONS of Busulfan (Busilvex)

             - Hypersensitivity to active substance or to any of the excipients listed in section 6.1.

             - Pregnancy

              

             https://www.ema.europa.eu/en/documents/product-information/busilvex-epar-product-information_en.pdf 04/08/2023 (withdrawn) 

 

Other trade names: Busulfan Fresenius Kabi,

 

 


          

Butylscopolamine

 

Ability to drive, butylscopolamine [2] ---> SPC of [2] of eMC

Patients should be advised that they may experience undesirable effects such as accommodation disorder or dizziness during treatment

 

Amantadine [1], butylscopolamine ---> SPC of [1] of eMC

Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects

 

Anticholinergics, butylscopolamine [2] ---> SPC of [2] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Antihistamines, butylscopolamine [2] ---> SPC of [2] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Atropine, butylscopolamine [2] ---> SPC of [2] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Beta-adrenergic agonists, butylscopolamine [2] ---> SPC of [2] of eMC

The tachycardic effects of beta-adrenergic agents may be enhanced by hyoscine butylbromide

 

Breast-feeding, butylscopolamine [2] ---> SPC of [2] of eMC

A risk to the breastfeeding child cannot be excluded. Use of hyoscine butylbromide during breastfeeding is not recommended.

 

Butylscopolamine [1], butyrophenones ---> SPC of [1] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Butylscopolamine [1], disopyramide ---> SPC of [1] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Butylscopolamine [1], dopamine antagonists ---> SPC of [1] of eMC

Concomitant treatment of hyoscine butylbromide with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.

 

Butylscopolamine [1], ipratropium ---> SPC of [1] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Butylscopolamine [1], metoclopramide ---> SPC of [1] of eMC

Concomitant treatment of hyoscine butylbromide with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.

 

Butylscopolamine [1], neuroleptics ---> SPC of [1] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Butylscopolamine [1], phenothiazines ---> SPC of [1] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Butylscopolamine [1], pregnancy ---> SPC of [1] of eMC

As a precautionary measure hyoscine butylbromide is not recommended during pregnancy.

 

Butylscopolamine [1], quinidine ---> SPC of [1] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Butylscopolamine [1], tetracyclic antidepressant ---> SPC of [1] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Butylscopolamine [1], tiotropium ---> SPC of [1] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Butylscopolamine [1], tricyclic antidepressant ---> SPC of [1] of eMC

The anticholinergic effect may be intensified by hyoscine butylbromide

 

Butylscopolamine, cisapride

Mutual weakening of effect on gastrointestinal motility

 

Butylscopolamine, digoxin

Butylscopolamine may impair the effect from other medicinal products as digoxine

 

 

           CONTRAINDICATIONS of Butylscopolamine

            

           - Buscopan Ampoules should not be administered to patients with myasthenia gravis, megacolon, narrow angle glaucoma, tachycardia, prostatic enlargement with urinary retention, mechanical stenoses in the region of the gastrointestinal tract or paralytic ileus.

           - Buscopan should not be used in patients who have demonstrated prior hypersensitivity to hyoscine butylbromide or any other component of the product.

           - BUSCOPAN ampoules should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur.

            

           http://www.medicines.org.uk/emc/







Bupivacaine liposomal (Exparel liposomal)

 

Ability to drive, liposomal bupivacaine [2] ---> SmPC of [2] of EMA

Patients should be informed in advance that bupivacaine liposomal dispersion can cause temporary loss of sensation or motor function.

 

Acetaminophen, local anaesthetics ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Articaine, local anaesthetics ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Benzocaine, local anaesthetics ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Breast-feeding, liposomal bupivacaine [2] ---> SmPC of [2] of EMA

Because of the potential for serious adverse reactions in breastfed infants a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from EXPAREL liposomal therapy

 

Bupivacaine [1], liposomal bupivacaine ---> SmPC of [1] of EMA

When EXPAREL liposomal is admixed with lidocaine, lidocaine binds to the liposomes, leading to an immediate displacement and release of bupivacaine.

 

Bupivacaine, liposomal bupivacaine [2] ---> SmPC of [2] of EMA

EXPAREL liposomal should only be admixed with bupivacaine as admixing with either lidocaine, ropivacaine or mepivacaine has been shown to cause an immediate release of bupivacaine from the multivesicular liposomes of the drug delivery system.

 

Bupivacaine, local anaesthetics [2] ---> SmPC of [2] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Chloroquine, local anaesthetics ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Cyclophosphamide, local anaesthetics ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Dapsone, local anaesthetics ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Flutamide, local anaesthetics ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Hydroxyurea, local anaesthetics ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Lidocaine, liposomal bupivacaine [2] ---> SmPC of [2] of EMA

There are no clinical data on the effects of EXPAREL liposomal on fertility.

 

Lidocaine, local anaesthetics [2] ---> SmPC of [2] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Liposomal bupivacaine [1], local anaesthetics ---> SmPC of [1] of EMA

EXPAREL liposomal should be used with caution in patients receiving other local anaesthetics or active substances structurally related to amide-type local anaesthetics, such as lidocaine and mexiletine, since the systemic toxic effects are additive.

 

Liposomal bupivacaine [1], mexiletine ---> SmPC of [1] of EMA

EXPAREL liposomal should be used with caution in patients receiving other local anaesthetics or active substances structurally related to amide-type local anaesthetics, such as lidocaine and mexiletine, since the systemic toxic effects are additive.

 

Liposomal bupivacaine [1], povidone iodine ---> SmPC of [1] of EMA

EXPAREL liposomal should not be allowed to come into contact with antiseptics such as povidone iodine in solution

 

Liposomal bupivacaine [1], pregnancy ---> SmPC of [1] of EMA

EXPAREL liposomal is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

Liposomal bupivacaine [1], topic antiseptic ---> SmPC of [1] of EMA

EXPAREL liposomal should not be allowed to come into contact with antiseptics such as povidone iodine in solution

 

Local anaesthetics, mepivacaine ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, metoclopramide ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, nitric oxide ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, nitrofurantoin ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, nitroglycerine ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, nitroprussiate ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, nitrous oxide ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, organic nitrates ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, para-aminosalicylic acid ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, phenobarbital ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, phenytoin ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, prilocaine ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, primaquine ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, procaine ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, quinine ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, rasburicase ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, ropivacaine [2] ---> SmPC of [2] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, sodium valproate ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, sulfasalazine ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, sulphamides ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, sulphonamides ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

Local anaesthetics, tetracaine ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

 

 

            CONTRAINDICATIONS of Bupivacaine liposomal (Exparel liposomal)

             

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Hypersensitivity to local anaesthetic medicinal products of the amide type.

            - Obstetrical paracervical block anaesthesia due to risk of foetal bradycardia or death.

            - Intravascular administration.

            - Intraarticular administration

             

            https://www.ema.europa.eu/en/documents/product-information/exparel-liposomal-epar-product-information_en.pdf 13/08/2025