E

Ebastine

Antihistamines, ebastine

Ebastine may enhance the effects of other antihistaminic agents

Azole antifungals, ebastine

The co-administration with CYP3A4 inhibitors may increase the plasma levels of ebastine and should be done with caution

Breast-feeding, ebastine

Ebastine should not be used during breast-feeding

Drugs inducing hypokaliemia, ebastine

The administration should be done with caution in patients with known heart risk such as hypokaliemia

Ebastine, erythromycin

Caution is advised with medicinal products that prolong the QT interval

Ebastine, itraconazol

The co-administration with CYP3A4 inhibitors may increase the plasma levels of ebastine and should be done with caution

Ebastine, ketoconazole [2] ---> SmPC of [2] of EMA

Increasing in plasma concentrations of ebastine have been observed. Not recommended due to an increased risk in QT prolongation

Ebastine, macrolide antibiotics

The co-administration with CYP3A4 inhibitors may increase the plasma levels of ebastine and should be done with caution

Ebastine, pregnancy

Ebastine should be used during pregnancy only when clearly needed

Ebastine, strong CYP3A4 inhibitors

The co-administration with CYP3A4 inhibitors may increase the plasma levels of ebastine and should be done with caution

QT interval prolonging drugs, ebastine

The administration should be done with caution in patients with known heart risk such as prolongation of QT interval

Ebola vaccine (Mvabea)

Breast-feeding, Ebola vaccine [2] ---> SmPC of [2] of EMA

Nevertheless, considering the severity of Ebola virus disease, vaccination should not be withheld when there is a clear risk of exposure to Ebola infection.

Breast-feeding, Ebola vaccine [2] ---> SmPC of [2] of EMA

As a precautionary measure, it is preferable to avoid vaccination with Mvabea during breast-feeding.

Ebola vaccine [1], fertility ---> SmPC of [1] of EMA

A reproductive toxicity study in animals with Zabdeno and Mvabea vaccine regimens did not reveal any evidence of impaired female fertility. General toxicity studies have not revealed any effects on male sex organs that would impair male fertility

Ebola vaccine [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is preferable to avoid vaccination with Mvabea during pregnancy.

Ebola vaccine [1], pregnancy ---> SmPC of [1] of EMA

Nevertheless, considering the severity of Ebola virus disease, vaccination should not be withheld when there is a clear risk of exposure to Ebola infection.

Ebola vaccine [1], vaccinations ---> SmPC of [1] of EMA

The safety, immunogenicity and efficacy of co-administration of Mvabea with other vaccines have not been evaluated, and therefore, co-administration is not recommended.

            CONTRAINDICATIONS of Ebola vaccine (Mvabea)

            Hypersensitivity to the active substance or to any of its excipients listed in section 6.1, or trace residues (chicken or egg protein and gentamicin).

            https://www.ema.europa.eu/en/documents/product-information/mvabea-epar-product-information_en.pdf 14/05/2025 

Other trade names: Zabdeno,

Ebola Zaire vaccine (Ervebo) 

Antiviral medication, Ebola Zaire vaccine [2] ---> SmPC of [2] of EMA

It is unknown whether concurrent administration of antiviral medication including interferons could impact vaccine virus replication and efficacy.

Breast-feeding, Ebola Zaire vaccine [2] ---> SmPC of [2] of EMA

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

Ebola Zaire vaccine [1], fertility ---> SmPC of [1] of EMA

There are no data on fertility effects in humans. Animal studies in female rats do not indicate harmful effects (see section 5.3).

Ebola Zaire vaccine [1], immunoglobulins ---> SmPC of [1] of EMA

Immune globulin (IG), blood or plasma transfusions should not be given concomitantly with Ervebo.

Ebola Zaire vaccine [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is preferable to avoid the use of Ervebo during pregnancy. Nevertheless considering the severity of EVD, vaccination should not be withheld when there is a clear risk of exposure to Ebola infection.

Ebola Zaire vaccine [1], pregnancy ---> SmPC of [1] of EMA

Pregnancy should be avoided for 2 months following vaccination. Women of child-bearing potential should use an effective contraceptive method.

Ebola Zaire vaccine [1], vaccinations ---> SmPC of [1] of EMA

As there are no data on co-administration of Ervebo with other vaccines, the concomitant use of Ervebo with other vaccines is not recommended.

             CONTRAINDICATIONS of Ebola Zaire vaccine (Ervebo)                          

             - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to rice protein listed in section 2.         

             https://www.ema.europa.eu/en/documents/product-information/ervebo-epar-product-information_en.pdf  19/09/2025 

Econazole

Acenocoumarol [1], econazole ---> SmPC of [1] of eMC

Patients taking oral anticoagulants, such as warfarin or acenocoumarol, caution should be exercised and the anticoagulant effect should be monitored more frequently.

Breast-feeding, econazole [2] ---> SmPC of [2] of eMC

Caution should be exercised when using the cream if the patient is breast-feeding.

Budipine, econazole

The co-administration of budipine with drugs known to prolong QT interval is contraindicated

Econazole [1], pregnancy ---> SmPC of [1] of eMC

Econazole should be used in pregnancy only if the practitioner considers it to be necessary.

Econazole [1], warfarin ---> SmPC of [1] of eMC

Patients taking oral anticoagulants, such as warfarin or acenocoumarol, caution should be exercised and the anticoagulant effect should be monitored more frequently.

Econazole, oral anticoagulants [2] ---> SmPC of [2] of eMC

Patients taking oral anticoagulants, such as warfarin or acenocoumarol, caution should be exercised and the anticoagulant effect should be monitored more frequently.

           CONTRAINDICATIONS of Econazole

           - Hypersensitivity to any imidazole preparation, other vaginal antifungal products or to any ingredients

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

Eculizumab (Soliris)

Breast-feeding, eculizumab [2] ---> SmPC of [2] of EMA

Due to the limitations of the available data, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eculizumab and any potential adverse effects on the breastfed child

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

No specific study of eculizumab on fertility has been conducted.

Eculizumab [1], immunoglobulins ---> SmPC of [1] of EMA

Concomitant use of eculizumab with intravenous immunoglobulin (IVIg) may reduce effectiveness of eculizumab. Closely monitor for reduced effectiveness of eculizumab.

Eculizumab [1], neonatal Fc receptor blockers ---> SmPC of [1] of EMA

Concomitant use of eculizumab with neonatal Fc receptor (FcRn) blockers may lower systemic exposures and reduce effectiveness of eculizumab. Closely monitor for reduced effectiveness of eculizumab.

Eculizumab [1], plasmapheresis ---> SmPC of [1] of EMA

Plasma exchange (PE), plasmapheresis (PP), fresh frozen plasma infusion (PI) and intravenous immunoglobulin (IVIg) have been shown to reduce eculizumab serum levels. A supplemental dose of eculizumab is required in these settings.

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

Soliris should be given to a pregnant woman only if clearly needed.

Eculizumab [1], rituximab ---> SmPC of [1] of EMA

Based on the potential inhibitory effect of eculizumab on complement-dependent cytotoxicity of rituximab, eculizumab may reduce the expected pharmacodynamic effects of rituximab.

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

The use of adequate contraception to prevent pregnancy and for at least 5 months after the last dose of treatment with eculizumab should be considered for women of childbearing potential.

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

Eculizumab is not cleaved by imlifidase at the recommended dose level. No time interval needed (can be administered concomitantly with imlifidase)

            CONTRAINDICATIONS of Eculizumab (Soliris)    

            - Hypersensitivity to eculizumab, murine proteins or to any of the excipients listed in section 6.1.

            Soliris therapy must not be initiated in patients (see section 4.4):

            - with unresolved Neisseria meningitidis infection

            - who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.

            https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf 18/07/2025 

Other trade names: Bekemv, Epysqli,

Edotreotide (SomaKit TOC)

Breast-feeding, edotreotide [2] ---> SmPC of [2] of EMA

If the administration is considered necessary, breastfeeding should be interrupted for 12 hours and the expressed feeds discarded.

Corticosteroids, edotreotide [2] ---> SmPC of [2] of EMA

Some evidence exists that corticosteroids can induce down-regulation of somatostatin subtype 2 receptors (SSTR2).

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

No studies were conducted to assess the impact on fertility.

Edotreotide [1], hypercortisolism ---> SmPC of [1] of EMA

A long-term exposure to endogenous hypercortisolism may down-regulate somatostatin receptor expression and negatively influence the results of somatostatin receptor imaging with gallium (68Ga) edotreotide.

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

Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.

Edotreotide [1], somatostatin analogues ---> SmPC of [1] of EMA

When treating patients with somatostatin analogues, it is preferable to perform imaging with gallium (68Ga) edotreotide the day(s) preceding the next administration of a somatostatin analogue.

Edotreotide [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.

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

If in doubt about her potential pregnancy (if the woman has missed a period, if her periods are very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.

            CONTRAINDICATIONS of Edotreotide (SomaKit TOC)     

            - Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the labelled radiopharmaceutical.      

            https://www.ema.europa.eu/en/documents/product-information/somakit-toc-epar-product-information_en.pdf 04/04/2025 

Edoxaban (Lixiana)

Acetylsalicylic acid, edoxaban [2] ---> SmPC of [2] of EMA

The concomitant chronic use of high dose ASA (325 mg) with edoxaban is not recommended. Concomitant administration of higher doses than 100 mg ASA should only be performed under medical supervision.

Agents which affect haemostasis, edoxaban [2] ---> SmPC of [2] of EMA

Concomitant use of medicines affecting haemostasis may increase the risk of bleeding.

Amiodarone, edoxaban [2] ---> SmPC of [2] of EMA

In ENGAGE AF-TIMI 48 study in NVAF, efficacy and safety results were similar for subjects with and without concomitant amiodarone use.

Anticoagulants, edoxaban [2] ---> SmPC of [2] of EMA

Co-administration of edoxaban with other anticoagulants is contraindicated due to increased risk of bleeding

Antithrombotics, edoxaban [2] ---> SmPC of [2] of EMA

Concomitant use of medicines affecting haemostasis may increase the risk of bleeding.

Atazanavir/cobicistat [1], edoxaban ---> SmPC of [1] of EMA

Co-administration with EVOTAZ may result in increased plasma concentrations of the DOACs, which may lead to an increased risk of bleeding. The mechanism of interaction is CYP3A4 and/or P-gp inhibition by cobicistat. Co-administration is not recommended

Breast-feeding, edoxaban [2] ---> SmPC of [2] of EMA

Lixiana is contraindicated during breast-feeding. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy.

Carbamazepine, edoxaban [2] ---> SmPC of [2] of EMA

The concomitant use of edoxaban with P-gp inducers may lead to reduced edoxaban plasma concentrations. Edoxaban should be used with caution when co-administered with P-gp inducers.

Clarithromycin, edoxaban [2] ---> SmPC of [2] of EMA

Clarithromycin (500 mg twice daily) for 10 days with a single concomitant dose of edoxaban 60 mg on day 9 increased the edoxaban AUC and Cmax by approximately 53% and 27%, respectively.

Clopidogrel, edoxaban [2] ---> SmPC of [2] of EMA

In ENGAGE AF-TIMI 48 concomitant use of thienopyridines (e.g. clopidogrel) monotherapy was permitted and resulted in increased clinically relevant bleeding although with a lower risk of bleeding on edoxaban compared to warfarin

Cobicistat [1], edoxaban ---> SmPC of [1] of EMA

Interaction not studied. Co-administration with cobicistat may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk. Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Tybost.

Cyclosporine, edoxaban [2] ---> SmPC of [2] of EMA

Edoxaban is a substrate for the efflux transporter P-gp. In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitor resulted in increased plasma concentrations of edoxaban.

Danicopan [1], edoxaban ---> SmPC of [1] of EMA

Caution may be needed in co-administering medicinal products that are known to be substrates of P-gp (such as dabigatran, digoxin, edoxaban, fexofenadine, tacrolimus).

Darunavir [1], edoxaban ---> SmPC of [1] of EMA

Darunavir/ritonavir: Clinical monitoring and/or dose reduction of the DOAC should be considered when a DOAC transported by P-gp but not metabolised by CYP3A4, including dabigatran etexilate and edoxaban, is co-administered with PREZISTA/rtv.

Darunavir/cobicistat [1], edoxaban ---> SmPC of [1] of EMA

Clinical monitoring and dose reduction is required when a DOAC transported by P-gp but not metabolised by CYP3A4, including dabigatran etexilate and edoxaban, is co-administered with REZOLSTA.

Darunavir/cobicistat, edoxaban

Clinical monitoring and dose reduction is required when a DOAC transported by P-gp but not metabolised by CYP3A4, including dabigatran etexilate and edoxaban, is co-administered with PREZISTA/cobi.

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], edoxaban ---> SmPC of [1] of EMA

Clinical monitoring and dose reduction is required when a DOAC transported by P-gp but not metabolised by CYP3A4, including dabigatran etexilate and edoxaban, is co-administered with Symtuza.

Digoxin, edoxaban [2] ---> SmPC of [2] of EMA

No dose modification is necessary when Lixiana is administered with digoxin.

Dronedarone, edoxaban

In in vivo studies edoxaban (a CYP3A4 and P-gp substrate) exposure was increased when administered with dronedarone. The edoxaban dose should be reduced according to the edoxaban label recommendations.

Dronedarone, edoxaban [2] ---> SmPC of [2] of EMA

Edoxaban is a substrate for the efflux transporter P-gp. In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitor resulted in increased plasma concentrations of edoxaban.

Dual antiplatelet therapy, edoxaban [2] ---> SmPC of [2] of EMA

There is very limited experience on the use of edoxaban with dual antiplatelet therapy or fibrinolytic agents.

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

Edoxaban is a substrate for the efflux transporter P-gp. In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitor resulted in increased plasma concentrations of edoxaban.

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

No specific studies with edoxaban in human beings have been conducted to evaluate effects on fertility. In a study on male and female fertility in rats no effects were seen (see section 5.3).

Edoxaban [1], fibrinolytics ---> SmPC of [1] of EMA

Concomitant use of medicines affecting haemostasis may increase the risk of bleeding.

Edoxaban [1], gastric emptying ---> SmPC of [1] of EMA

Edoxaban is predominantly absorbed in the upper gastrointestinal (GI) tract. Thus, medicinal products or disease conditions that increase gastric emptying and gut motility have the possibility of reducing edoxaban dissolution and absorption.

Edoxaban [1], intestinal motility ---> SmPC of [1] of EMA

Edoxaban is predominantly absorbed in the upper gastrointestinal (GI) tract. Thus, medicinal products or disease conditions that increase gastric emptying and gut motility have the possibility of reducing edoxaban dissolution and absorption.

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

Edoxaban is a substrate for the efflux transporter P-gp. In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitor resulted in increased plasma concentrations of edoxaban.

Edoxaban [1], lenacapavir ---> SmPC of [1] of EMA

Plasma concentration of DOAC may be increased when co-administered with lenacapavir. Due to potential bleeding risk, dose adjustment of DOAC may be required.

Edoxaban [1], NSAID ---> SmPC of [1] of EMA

In clinical studies, co-administration of NSAIDs resulted in increased clinically relevant bleeding. Chronic use of NSAIDs with edoxaban is not recommended.

Edoxaban [1], P2Y12 platelet inhibitors ---> SmPC of [1] of EMA

Concomitant use of medicines affecting haemostasis may increase the risk of bleeding.

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

The concomitant use of edoxaban with P-gp inducers may lead to reduced edoxaban plasma concentrations. Edoxaban should be used with caution when co-administered with P-gp inducers.

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

The concomitant use of edoxaban with P-gp inducers may lead to reduced edoxaban plasma concentrations. Edoxaban should be used with caution when co-administered with P-gp inducers.

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

Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that edoxaban passes the placenta, Lixiana is contraindicated during pregnancy.

Edoxaban [1], prokinetics ---> SmPC of [1] of EMA

Edoxaban is predominantly absorbed in the upper gastrointestinal (GI) tract. Thus, medicines or disease conditions that increase gastric emptying and gut motility have the possibility of reducing edoxaban dissolution and absorption.

Edoxaban [1], quinidine ---> SmPC of [1] of EMA

Edoxaban is a substrate for the efflux transporter P-gp. In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitor resulted in increased plasma concentrations of edoxaban. Concomitant use does not require dose reduction

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

Co-administration of edoxaban with the P-gp inducer rifampicin led to a decrease in mean edoxaban AUC and a shortened half-life, with possible decreases in its pharmacodynamic effects.

Edoxaban [1], SNRIs ---> SmPC of [1] of EMA

As with other anticoagulants the possibility may exist that patients are at increased risk of bleeding in case of concomitant use with SSRIs or SNRIs due to their reported effect on platelets

Edoxaban [1], SSRI ---> SmPC of [1] of EMA

As with other anticoagulants the possibility may exist that patients are at increased risk of bleeding in case of concomitant use with SSRIs or SNRIs due to their reported effect on platelets

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

The concomitant use of edoxaban with P-gp inducers may lead to reduced edoxaban plasma concentrations. Edoxaban should be used with caution when co-administered with P-gp inducers.

Edoxaban [1], strong P-gp inductors ---> SmPC of [1] of EMA

The concomitant use of edoxaban with P-gp inducers may lead to reduced edoxaban plasma concentrations. Edoxaban should be used with caution when co-administered with P-gp inducers.

Edoxaban [1], strong P-gp inhibitors ---> SmPC of [1] of EMA

The use of edoxaban with other P-gp inhibitors including HIV protease inhibitors has not been studied.

Edoxaban [1], thienopyridines ---> SmPC of [1] of EMA

In ENGAGE AF-TIMI 48 concomitant use of thienopyridines (e.g. clopidogrel) monotherapy was permitted and resulted in increased clinically relevant bleeding although with a lower risk of bleeding on edoxaban compared to warfarin

Edoxaban [1], verapamil ---> SmPC of [1] of EMA

Edoxaban is a substrate for the efflux transporter P-gp. In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitor resulted in increased plasma concentrations of edoxaban. Concomitant use does not require dose reduction

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

Women of childbearing potential should avoid becoming pregnant during treatment with edoxaban.

Edoxaban, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration with Genvoya may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk. Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Genvoya.

Edoxaban, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Co-administration with Stribild may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk. Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Stribild.

Edoxaban, ketoconazole [2] ---> SmPC of [2] of EMA

Dose of edoxaban needs to be reduced when used concomitantly, please consult edoxaban SmPC.

Edoxaban, ritonavir [2] ---> SmPC of [2] of EMA

Clinical monitoring and/or dose reduction of the direct oral anticoagulants (DOAC) should be considered when a DOAC transported by P-gp but not metabolised by CYP3A4, including dabigatran etexilate and edoxaban, is co-administered with ritonavir.

Edoxaban, sofosbuvir/velpatasvir/voxilaprevir [2] ---> SmPC of [2] of EMA

Inhibition of OATP1B1. Co-administration of Vosevi with edoxaban is not recommended. Should direct Xa inhibitor use be deemed necessary, apixaban or rivaroxaban may be considered.

            CONTRAINDICATIONS of Edoxaban (Lixiana)

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

            - Clinically significant active bleeding.

            - Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.

            - Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.

            - Uncontrolled severe hypertension.

            - Concomitant treatment with any other anticoagulants e.g. UFH, LMWH (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, rivaroxaban, apixaban etc.) except under specific circumstances of switching oral anticoagulant therapy (see section 4.2) or when UFH is given at doses necessary to maintain an open central venous or arterial catheter (see section 4.5).

            - Pregnancy and breast-feeding (see section 4.6).

            https://www.ema.europa.eu/en/documents/product-information/lixiana-epar-product-information_en.pdf 06/12/2024

Other trade names: Roteas,

Efalizumab (Raptiva)

Breast-feeding, efalizumab [2] ---> SmPC of [2] of EMA

Women should not breastfeed during treatment

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

The efalizumab effects on the immune system may be potentiated by systemic immunosuppressives used for the treatment of psoriasis

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

Should not be used during pregnancy

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

Patients should not receive live and live-attenuated vaccines during treatment

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

Patients should not receive live and live-attenuated vaccines during treatment

            CONTRAINDICATIONS of Efalizumab (Raptiva)

            - Hypersensitivity to efalizumab or to any of the excipients.

            - Patients with history of malignancies.

            - Patients with active tuberculosis and other severe infections.

            - Patients with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.

            - Patients with immunodeficiencies.

            https://www.ema.europa.eu/en/documents/product-information/raptiva-epar-product-information_en.pdf 04/08/2009 (withdrawn)

Efanesoctocog alfa (Altuvoct)

Breast-feeding, efanesoctocog alfa [2] ---> SmPC of [2] of EMA

Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available. Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.

Efanesoctocog alfa [1], medicinal products ---> SmPC of [1] of EMA

No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported. No interaction studies have been performed.

Efanesoctocog alfa [1], pregnancy ---> SmPC of [1] of EMA

Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available. Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.

            CONTRAINDICATIONS of Efanesoctocog alfa (Altuvoct)

            - 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/altuvoct-epar-product-information_en.pdf 12/07/2024             

Efavirenz (Efavirenz Teva)

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

Efavirenz may cause dizziness, impaired concentration, and/or somnolence. Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.

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

Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin)

Acenocoumarol, efavirenz [2] ---> SmPC of [2] of EMA

Increased/decreased plasma concentrations of acenocoumarol

Allopurinol/lesinurad [1], efavirenz ---> SmPC of [1] 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 lesinurad.

Alprazolam, efavirenz

May increase the effect and toxicity of alprazolam

Aluminium hydroxide, efavirenz [2] ---> SmPC of [2] of EMA

Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.

Amprenavir/saquinavir, efavirenz ---> SmPC of [amprenavir] of EMA

Significant decreased exposition of both protease inhibitors. Co-administration is not recommended

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

Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.

Antidepressants, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

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

When substrates of CYP2B6 (e.g., efavirenz) are administered with Erleada, monitoring for an adverse reaction and evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required

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

The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.

Arrhythmogenic drug, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

Astemizole, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

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

The mechanism of efavirenz/atazanavir interaction is CYP3A4 induction. Co-administration of efavirenz and REYATAZ is not recommended

Atazanavir/cobicistat [1], efavirenz ---> 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, efavirenz [2] ---> SmPC of [2] of EMA

The CYP3A4 induction by efavirenz may decrease the exposition of atazanavir. Co-administration of efavirenz with atazanavir/ritonavir is not recommended

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

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of atorvastatin. Cholesterol levels should be periodically monitored.

Atovaquone [1], efavirenz ---> SmPC of [1] of eMC

When given with efavirenz or boosted protease-inhibitors, atovaquone concentrations have been observed to decrease as much as 75%. This combination should be avoided whenever possible

Atovaquone/proguanil, efavirenz [2] ---> SmPC of [2] of EMA

The co-administration decreases the plasma concentrations of atovaquone and proguanil. Concomitant administration of atovaquone/proguanil with efavirenz should be avoided whenever possible.

Avacopan [1], efavirenz ---> 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], efavirenz ---> 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], efavirenz ---> 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

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

No clinically significant pharmacokinetic interaction. No dose adjustment is necessary for either medicinal product.

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.

Bepridil, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz must not be administered concurrently with the other medicine, since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).

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

Plasma trough concentrations of Victrelis were decreased when administered with efavirenz. CYP3A induction - effect on boceprevir

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.

Breast-feeding, efavirenz [2] ---> SmPC of [2] of EMA

Risk to the infant can not be excluded. Breast-feeding should be discontinued during treatment with efavirenz. It is recommended that women living with HIV do not breast-feed their infants in order to avoid transmission of HIV.

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.

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

Brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz).

Brotizolam, efavirenz

The strong CYP3A4 induction may decrease the plasma concentrations of brotizolam

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.

Bupropion [1], efavirenz ---> SmPC 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.

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

In vitro data demonstrate that cabozantinib is a substrate of MRP2. Therefore, administration of MRP2 inhibitors may result in increases in cabozantinib plasma concentrations.

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

Enzyme inducers may give rise to decreased exposure of canagliflozin. These decreases in exposure to canagliflozin may decrease efficacy.

Canagliflozin/metformin [1], efavirenz ---> SmPC of [1] of EMA

Enzyme inducers may give rise to decreased exposure of canagliflozin. These decreases in exposure to canagliflozin may decrease efficacy.

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

Decreases in capmatinib exposure may decrease Tabrecta anti-tumour activity. Caution should be exercised during co-administration of Tabrecta with moderate CYP3A inducers.

Carbamazepine, efavirenz [2] ---> SmPC of [2] of EMA

The CYP3A4 induction decreases the plasma concentrations of carbamazepine and efavirenz

Cariprazine [1], efavirenz ---> SmPC of [1] 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

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

When co-administering inducers of metabolic enzymes, an increase in the daily dose of caspofungin to 70 mg, following the 70 mg loading dose, should be considered in adult patients (see section 4.2).

Cetirizine, efavirenz [2] ---> SmPC of [2] of EMA

The changes in plasma levels of cetirizine are not considered clinically significant. No dose adjustment is necessary for either medicinal product.

Cisapride, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

Clarithromycin, efavirenz [2] ---> SmPC of [2] of EMA

The clinical significance of the changes in clarithromycin plasma levels is not known. Alternatives to clarithromycin (e.g. azithromycin) may be considered. No dose adjustment is necessary for efavirenz

Class I antiarrhythmic agents, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

Class III antiarrhythmic agents, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

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

As a precaution, concomitant use of strong CYP2C19 inducers should be discouraged (see section 4.4).

Clopidogrel/acetylsalicylic acid [1], efavirenz ---> SmPC of [1] of EMA

The clinical relevance of this interaction is uncertain. As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).

Cobicistat [1], efavirenz ---> SmPC of [1] 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

Conjugated oestrogens/bazedoxifene [1], efavirenz ---> SmPC of [1] of EMA

The metabolism of oestrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes

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

The effect of a moderate inducer including but not limited to efavirenz or rifabutin is not clearly established; therefore, their combination with crizotinib should be also avoided (see section 4.4).

Cyclophosphamide, efavirenz

The CYP2B6 and CYP3A4 inhibition may decrease the efficacy of cyclophosphamide (prodrug)

Cyclosporine, efavirenz [2] ---> SmPC of [2] of EMA

Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction). This immunosuppressant is not anticipated to affect exposure of efavirenz.

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

Interactions with many medicinal products eliminated through metabolism or active transport is expected. These medicinal products are to be avoided or used with caution.

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

Induction of CYP3A4 by efavirenz may decrease the daclatasvir concentration

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

In healthy subjects, co-administration with efavirenz (600 mg once daily), a moderate CYP3A4 inducer, decreased daridorexant exposure parameters AUC and Cmax by 61% and 35%, respectively.

Darunavir/cobicistat, efavirenz ---> 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

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], efavirenz ---> SmPC of [1] of EMA

Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations of darunavir and cobicistat

Darunavir/ritonavir, efavirenz [2] ---> SmPC of [2] of EMA

Increased exposition of efavirenz (CYP3A4 inhibition) and decreased exposition of darunavir (CYP3A4 induction). Efavirenz in combination with darunavir/ritonavir may result in suboptimal darunavir Cmin.

Dasabuvir with ombitasvir/paritaprevir/ritonavir, efavirenz ---> SmPC of [dasabuvir] of EMA

Co-administration (contraindicated) of dasabuvir with medicinal products that are strong or moderate enzyme inducers is expected to decrease dasabuvir plasma concentrations and reduce its therapeutic effect

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

Co-administration (contraindicated) of dasabuvir with medicinal products that are strong or moderate enzyme inducers is expected to decrease dasabuvir plasma concentrations and reduce its therapeutic effect

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

No clinically relevant reduction in delamanid exposure was observed with the weak inducer efavirenz when administered at a dose of 600 mg daily for 10 days in combination with delamanid 100 mg twice daily.

Delavirdine, efavirenz

The co-administration of efavirenz with another non-nucleoside reverse transcriptase inhibitor is not recommended

Dihydroergotamine, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz must not be administered concurrently with the other medicine, since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).

Diltiazem, efavirenz [2] ---> SmPC of [2] of EMA

The CYP3A4 induction by efavirenz may decrease the diltiazem concentration

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

Efavirenz, UGT1A1 and CYP3A inductor, decreased dolutegravir plasma levels. In the presence of integrase class resistance alternative combinations that do not include efavirenz should be considered

Dolutegravir/abacavir/lamivudine [1], efavirenz ---> SmPC of [1] of EMA

The recommended dose of dolutegravir is 50 mg twice daily when coadministered with efavirenz.

Dolutegravir/lamivudine [1], efavirenz ---> SmPC of [1] of EMA

As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the efavirenz co-administration. Induction of UGT1A1 and CYP3A enzymes

Drospirenone/estetrol [1], efavirenz ---> SmPC of [1] of EMA

Medicinal products increasing the clearance of CHCs

Drugs metabolised by CYP2B6, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is an in vivo inducer of CYP3A4, CYP2B6 and UGT1A1. Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz.

Drugs metabolised by CYP3A4, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is an in vivo inducer of CYP3A4, CYP2B6 and UGT1A1. Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz.

Drugs metabolised by UGT1A1, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is an in vivo inducer of CYP3A4, CYP2B6 and UGT1A1. Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz.

Drugs primarily metabolised by CYP2B6, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is an in vivo inducer of CYP3A4, CYP2B6 and UGT1A1. Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz.

Drugs primarily metabolised by CYP3A4 with narrow therapeutic index, efavirenz [2] ---> SmPC of [2] of EMA

Theoretically, efavirenz may initially increase the exposure to CYP3A4 substrates and caution is warranted for CYP3A4 substrates with narrow therapeutic index

Drugs primarily metabolised by CYP3A4, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is an in vivo inducer of CYP3A4, CYP2B6 and UGT1A1. Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz.

Drugs primarily metabolised by UGT1A1, efavirenz [2] ---> SmPC of [2] of EMA

Efavirenz is an in vivo inducer of CYP3A4, CYP2B6 and UGT1A1. Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz.

Dydrogesterone/estradiol [1], efavirenz ---> SmPC of [1] of eMC

The metabolism of oestrogens and progestagens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes

Efavirenz [1], elacestrant ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

Efavirenz [1], ergonovine ---> SmPC of [1] of EMA

Efavirenz must not be administered concurrently with the other medicine, since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).

Efavirenz [1], ergot derivatives ---> SmPC of [1] of EMA

Efavirenz must not be administered concurrently with the other medicine, since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).

Efavirenz [1], ergotamine ---> SmPC of [1] of EMA

Efavirenz must not be administered concurrently with the other medicine, since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).

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

No data are available to make a dose recommendation

Efavirenz [1], etonogestrel ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of etonogestrel. A reliable method of barrier contraception must be used in addition to hormonal contraceptives

Efavirenz [1], famotidine ---> SmPC of [1] of EMA

Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.

Efavirenz [1], felodipine ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of calcium antagonist

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

In these studies, efavirenz did not impair mating or fertility of male or female rats (doses up to 100 mg/kg/bid), and did not affect sperm or offspring of treated male rats (doses up to 200 mg/bid).

Efavirenz [1], flecainide ---> SmPC of [1] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

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

No clinically significant pharmacokinetic interaction. No dose adjustment is necessary for either medicinal product.

Efavirenz [1], fluoxetine ---> SmPC of [1] of EMA

No dose adjustment is necessary for either medicinal product.

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

It is recommended that efavirenz be taken on an empty stomach. The increased efavirenz concentrations observed following administration of efavirenz with food may lead to an increase in frequency of adverse reactions (see sections 4.4 and 5.2).

Efavirenz [1], fosamprenavir/nelfinavir ---> SmPC of [1] of EMA

No dose adjustment is necessary for any of these medicinal products.

Efavirenz [1], fosamprenavir/saquinavir ---> SmPC of [1] of EMA

Not recommended as the exposure to both PIs is expected to be significantly decreased.

Efavirenz [1], gabapentin ---> SmPC of [1] of EMA

Clinically significant interactions are not expected since gabapentin is exclusively eliminated unchanged in the urine

Efavirenz [1], gastric pH increasing medication ---> SmPC of [1] of EMA

Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.

Efavirenz [1], ginkgo biloba extracts ---> SmPC of [1] of EMA

Compounds or herbal preparations (for example Ginkgo biloba extracts and St. John's wort) which induce these enzymes may give rise to decreased plasma concentrations of efavirenz. Concomitant use of Ginkgo biloba extracts is not recommended

Efavirenz [1], grapefruit juice ---> SmPC of [1] of EMA

Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.

Efavirenz [1], H2 antagonists ---> SmPC of [1] of EMA

Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.

Efavirenz [1], half life ---> SmPC of [1] of EMA

Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of efavirenz is recommended.

Efavirenz [1], immunosuppressants metabolised by CYP3A4 ---> SmPC of [1] of EMA

Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction). These immunosuppressants are not anticipated to affect exposure of efavirenz.

Efavirenz [1], indinavir ---> SmPC of [1] of EMA

While the clinical significance of decreased indinavir concentrations has not been established, the magnitude of the observed pharmacokinetic interaction should be taken into consideration when choosing a regimen containing both efavirenz and indinavir.

Efavirenz [1], indinavir/ritonavir ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of indinavir/ritonavir. No dose adjustment is necessary for efavirenz when given with indinavir or indinavir/ritonavir.

Efavirenz [1], inducing torsades de pointes ---> SmPC of [1] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

Efavirenz [1], itraconazol ---> SmPC of [1] of EMA

The CYP3A4 induction decreases the plasma concentrations of itraconazol. Concomitant use should be avoided

Efavirenz [1], levonorgestrel ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations and the effect of levonorgestrel. A reliable method of barrier contraception must be used in addition to hormonal contraceptives

Efavirenz [1], lopinavir/ritonavir ---> SmPC of [1] of EMA

Significant decreased exposition of lopinavir. The Kaletra dosage should be increased when co-administered with efavirenz.

Efavirenz [1], lorazepam ---> SmPC of [1] of EMA

The changes in plasma levels of lorazepam are not considered clinically significant. No dose adjustment is necessary for either medicinal product.

Efavirenz [1], macrolide antibiotics ---> SmPC of [1] of EMA

No data are available to make a dose recommendation

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

Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.

Efavirenz [1], methadone ---> SmPC of [1] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

Efavirenz [1], methylergonovine ---> SmPC of [1] of EMA

Efavirenz must not be administered concurrently with the other medicine, since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).

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

Efavirenz must not be administered concurrently with the other medicine, since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).

Efavirenz [1], nelfinavir ---> SmPC of [1] of EMA

No dose adjustment is necessary for either medicinal product.

Efavirenz [1], neuroleptics ---> SmPC of [1] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

Efavirenz [1], nicardipine ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of calcium antagonist

Efavirenz [1], nifedipine ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of calcium antagonist

Efavirenz [1], non-nucleoside reverse transcriptase inhibitors ---> SmPC of [1] of EMA

The co-administration of efavirenz with another non-nucleoside reverse transcriptase inhibitor is not recommended

Efavirenz [1], nucleoside analogue reverse transcriptase inhibitors ---> SmPC of [1] of EMA

No dose adjustment is necessary for either medicinal product.

Efavirenz [1], nucleoside and nucleotide reverse transcriptase inhibitors ---> SmPC of [1] of EMA

No dose adjustment is necessary for either medicinal product.

Efavirenz [1], oral contraceptives ---> SmPC of [1] of EMA

Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives, see section 4.5).

Efavirenz [1], paroxetine ---> SmPC of [1] of EMA

No dose adjustment is necessary for either medicinal product.

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

Increased/decreased plasma concentrations of phenobarbital (CYP3A4 substrate)

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

Increased/decreased plasma concentrations of phenytoin (CYP3A4 substrate)

Efavirenz [1], pimozide ---> SmPC of [1] of EMA

Efavirenz must not be administered concurrently with the other medicine, since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).

Efavirenz [1], pravastatine ---> SmPC of [1] of EMA

Efavirenz may decrease the plasma concentrations of statine. Cholesterol levels should be periodically monitored.

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

Efavirenz should not be used during pregnancy, unless the patient's clinical condition requires such treatment

Efavirenz [1], proton pump inhibitors ---> SmPC of [1] of EMA

Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.

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

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

Efavirenz [1], raltegravir ---> SmPC of [1] of EMA

The induction of UGT1A1 may reduce plasma levels of raltegravir. No dosage adjustment necessary.

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

The CYP3A4 induction by efavirenz decreases the plasma concentrations of rifabutin

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

The CYP3A4 and CYP2B6 induction by rifampicin decreases the plasma concentrations of efavirenz

Efavirenz [1], rosuvastatin ---> SmPC of [1] of EMA

No dose adjustment is necessary for either medicinal product.

Efavirenz [1], saquinavir ---> SmPC of [1] of EMA

May decrease the plasma levels of saquinavir. Use of efavirenz in combination with saquinavir as the sole protease inhibitor is not recommended.

Efavirenz [1], saquinavir/ritonavir ---> SmPC of [1] of EMA

May decrease the plasma levels of saquinavir. Use of efavirenz in combination with saquinavir as the sole protease inhibitor is not recommended.

Efavirenz [1], sertraline ---> SmPC of [1] of EMA

The CYP3A4 induction by efavirenz decreases the plasma concentrations of sertraline

Efavirenz [1], simeticone ---> SmPC of [1] of EMA

Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.

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

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of statine. Cholesterol levels should be periodically monitored.

Efavirenz [1], sirolimus ---> SmPC of [1] of EMA

Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction). This immunosuppressant is not anticipated to affect exposure of efavirenz.

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

Compounds or herbal preparations (for example Ginkgo biloba extracts and St. John's wort) which induce these enzymes may give rise to decreased plasma concentrations of efavirenz. Concomitant use of St. John's wort is contraindicated

Efavirenz [1], strong CYP2B6 inductors ---> SmPC of [1] of EMA

Compounds which induce CYP3A4 or CYP2B6 activity may give rise to decreased plasma concentrations of efavirenz.

Efavirenz [1], strong CYP2B6 inhibitors ---> SmPC of [1] of EMA

Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.

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

Compounds which induce CYP3A4 or CYP2B6 activity may give rise to decreased plasma concentrations of efavirenz.

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

Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.

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

Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction). This immunosuppressant is not anticipated to affect exposure of efavirenz.

Efavirenz [1], telaprevir ---> SmPC of [1] of EMA

If efavirenz and telaprevir are coadministered, telaprevir 1,125 mg every 8 hours should be used.

Efavirenz [1], tenofovir ---> SmPC of [1] of EMA

No clinically significant pharmacokinetic interaction. No dosage adjustment necessary.

Efavirenz [1], terfenadine ---> SmPC of [1] of EMA

Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes)

Efavirenz [1], triazolam ---> SmPC of [1] of EMA

Efavirenz must not be administered concurrently with the other medicine, since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).

Efavirenz [1], valproic acid ---> SmPC of [1] of EMA

No dose adjustment is necessary for efavirenz. Patients should be monitored for seizure control.

Efavirenz [1], verapamil ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of calcium antagonist

Efavirenz [1], vigabatrin ---> SmPC of [1] of EMA

Clinically significant interactions are not expected since vigabatrin is exclusively eliminated unchanged in the urine

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

Increased/decreased plasma concentrations of warfarin

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

Women of childbearing potential should undergo pregnancy testing before initiation of efavirenz.

Efavirenz [1], zidovudine ---> SmPC of [1] of EMA

No clinically significant pharmacokinetic interaction. No dosage adjustment necessary.

Efavirenz, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Co-administration is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir. This loss is due to significant decreases in elbasvir and grazoprevir plasma concentrations caused by CYP3A4 induction.

Efavirenz, 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

Efavirenz, emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

The recommended dose of Descovy is 200/25 mg once daily.

Efavirenz, emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

No dose adjustment of efavirenz is required.

Efavirenz, estradiol valerate/norgestrel [2] ---> SmPC of [2] of eMC

The metabolism of oestrogens and progestagens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes

Efavirenz, estradiol [2] ---> SmPC of [2] of eMC

The metabolism of estrogens and progestagens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes

Efavirenz, estradiol/norethisterone [2] ---> SmPC of [2] of eMC

The metabolism of oestrogens and progestogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes

Efavirenz, estriol [2] ---> SmPC of [2] of eMC

The metabolism of estrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes

Efavirenz, estrogens ---> SmPC of [estradiol] of eMC

The metabolism of estrogens and progestagens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes

Efavirenz, ethinylestradiol/desogestrel [2] ---> SmPC of [2] of eMC

Interactions can occur with drugs that induce microsomal enzymes, which can result in increased clearance of sex hormones

Efavirenz, etravirine [2] ---> SmPC of [2] of EMA

Possible decreased plasma concentrations of etravirine. It is not recommended to co-administer etravirine with other non-nucleoside reverse transcriptase inhibitors

Efavirenz, everolimus [2] ---> SmPC of [2] of EMA

Decreased exposure of everolimus expected. Avoid the use of concomitant potent CYP3A4 inducers.

Efavirenz, ezetimibe/atorvastatin [2] ---> SmPC of [2] of eMC

Concomitant administration of atorvastatin with inducers of cytochrome P450 3A4 (e.g., efavirenz, rifampicin, St. John's Wort) can lead to variable reductions in plasma concentrations of atorvastatin.

Efavirenz, fedratinib [2] ---> SmPC of [2] of EMA

Agents that strongly or moderately induce CYP3A4 (e.g. phenytoin, rifampicin, efavirenz) can decrease Inrebic exposure and should be avoided in patients receiving Inrebic

Efavirenz, felodipine/metoprolol

It has been shown that inductors of cytochrome P450-3A4 system decrease the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inductors should be avoided

Efavirenz, finerenone [2] ---> SmPC of [2] of EMA

Kerendia should not be used concomitantly with strong or moderate CYP3A4 inducers. These CYP3A4 inducers are expected to markedly decrease finerenone plasma concentration and result in reduced therapeutic effect (see section 4.4).

Efavirenz, fingolimod [2] ---> SmPC of [2] of EMA

Co-administration of fingolimod with strong CYP3A4 enzyme inducers may reduce the AUC of fingolimod and its metabolite. The co-administration should be used with caution.

Efavirenz, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA

No clinically significant pharmacokinetic interaction. No dosage adjustment necessary.

Efavirenz, fostemsavir [2] ---> SmPC of [2] of EMA

Temsavir (induction of CYP3A enzymes). This interaction has not been studied. Efavirenz is expected to decrease temsavir plasma concentrations. No dose adjustment is necessary.

Efavirenz, futibatinib [2] ---> SmPC of [2] of EMA

Co-administration of futibatinib with strong or moderate CYP3A4/P-gp inducers, such as rifampicin, should be avoided. If this is not possible, gradually increasing the futibatinib dose based on careful monitoring of tolerability should be considered.

Efavirenz, ganciclovir ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Efavirenz, gestagens ---> SmPC of [estradiol] of eMC

The metabolism of estrogens and progestagens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes

Efavirenz, 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

Efavirenz, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration with efavirenz may lead to reduced therapeutic effect of Maviret and is not recommended.

Efavirenz, 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

Efavirenz, hydrocortisone [2] ---> SmPC of [2] of EMA

Potent CYP 3A4 inducers can enhance the metabolic clearance of cortisol, decrease terminal half-life and thus reduce circulating levels and increase fluctuations of cortisol (due to shorter terminal half-life).

Efavirenz, ibrutinib [2] ---> SmPC 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.

Efavirenz, interferon

Caution should be used when administering interferon with medicines mainly metabolised by hepatic cytochrome P450 and have a narrow therapeutic window

Efavirenz, isavuconazole [2] ---> SmPC of [2] of EMA

Co-administration of CRESEMBA with potent/moderate CYP3A4/5 inducers is contraindicated, since these medicinal products can significantly decrease plasma concentrations of isavuconazole

Efavirenz, lamivudine/raltegravir [2] ---> SmPC of [2] of EMA

The induction of UGT1A1 may decrease raltegravir exposition. No dosage adjustment necessary.

Efavirenz, larotrectinib [2] ---> SmPC of [2] of EMA

In vitro studies indicate that larotrectinib induces CYP2B6. Co-administration of larotrectinib with CYP2B6 substrates (e.g. bupropion, efavirenz) may decrease their exposure.

Efavirenz, lefamulin [2] ---> SmPC of [2] of EMA

Moderate induction of CYP3A4. Co-administration of moderate CYP3A inducers may result in reduced therapeutic effect of lefamulin and is contraindicated

Efavirenz, lenacapavir [2] ---> SmPC of [2] of EMA

Moderate inducers of CYP3A and P-gp, such as efavirenz, may also significantly decrease plasma concentrations of lenacapavir, therefore co-administration is not recommended

Efavirenz, lesinurad [2] ---> SmPC 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.

Efavirenz, letermovir [2] ---> SmPC of [2] of EMA

Efavirenz may decrease plasma concentrations of letermovir. Co-administration of PREVYMIS and efavirenz is not recommended.

Efavirenz, lorlatinib [2] ---> SmPC of [2] of EMA

Concomitant administration of lorlatinib with CYP2B6 substrates (e.g. bupropion, efavirenz) may result in reduced plasma concentrations of the CYP2B6 substrate.

Efavirenz, 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.

Efavirenz, macimorelin [2] ---> SmPC of [2] of EMA

Administration of a CYP3A4 inducer may reduce the plasma macimorelin concentrations and may affect the diagnostic performance of the test and therefore should be avoided.

Efavirenz, maraviroc [2] ---> SmPC of [2] of EMA

Efavirenz may decrease the plasma concentrations of maraviroc. Maraviroc dose should be increased to 600 mg twice daily when co-administered with efavirenz in the absence of a potent CYP3A4 inhibitor.

Efavirenz, maribavir [2] ---> SmPC of [2] of EMA

If co-administration of LIVTENCITY with other strong or moderate CYP3A inducers (e,g., carbamazepine, efavirenz, phenobarbital and phenytoin) cannot be avoided, the LIVTENCITY dose should be increased to 1 200 mg twice daily

Efavirenz, medroxyprogesterone ---> SmPC of [estradiol] of eMC

The metabolism of progestogens may be increased by concomitant administration of compounds known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes.

Efavirenz, mefloquine [2] ---> SmPC of [2] of eMC

Inductors of the isoenzyme CYP3A4 may modify the pharmacokinetics/metabolism of mefloquine, leading to an decrease in mefloquine plasma concentration.

Efavirenz, midostaurin [2] ---> SmPC of [2] of EMA

Medicinal products with a narrow therapeutic range that are substrates of CYP2B6 (e.g. bupropion or efavirenz) should be used with caution when administered concomitantly with midostaurin, and may need dose adjustment to maintain optimal exposure.

Efavirenz, naldemedine [2] ---> SmPC of [2] of EMA

Concomitant use of naldemedine with moderate inducers (e.g. efavirenz) has not been established, and patients should be monitored (see section 4.4).

Efavirenz, naltrexone/bupropion [2] ---> SmPC of [2] of EMA

Since bupropion is extensively metabolised, caution is advised when naltrexone/bupropion is co-administered with medicinal products known to induce CYP2B6 as these may affect the clinical efficacy of naltrexone/bupropion.

Efavirenz, 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

Efavirenz, nevirapine [2] ---> SmPC of [2] of EMA

It is not recommended to co-administer efavirenz and nevirapine, because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone

Efavirenz, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA

A higher frequency of adverse reactions (e.g., dizziness, nausea, paraesthesia) and laboratory abnormalities (elevated liver enzymes) have been observed when efavirenz is coadministered with ritonavir.

Efavirenz, nomegestrol/estradiol [2] ---> SmPC of [2] of EMA

Interactions between oral contraceptives and enzyme-inducing medicinal products may lead to breakthrough bleeding and even contraceptive failure.

Efavirenz, 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

Efavirenz, norgestimate

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of norelgestromin

Efavirenz, olaparib [2] ---> SmPC of [2] of EMA

The magnitude of the effect of moderate to strong inducers (e.g. efavirenz, rifabutin) on olaparib exposure is not established, therefore the co-administration of Lynparza with these medicinal products is also not recommended (see section 4.4).

Efavirenz, omaveloxolone [2] ---> SmPC of [2] of EMA

Omaveloxolone is a CYP3A4 substrate. Concomitant use of Skyclarys with strong or moderate CYP3A4 inducers may significantly decrease the exposure of omaveloxolone, which may reduce the effectiveness of Skyclarys.

Efavirenz, ombitasvir/paritaprevir/ritonavir [2] ---> SmPC of [2] of EMA

Coadministration of Viekirax with/without dasabuvir with drugs that are strong or moderate enzyme inducers is expected to decrease ombitasvir, paritaprevir, and ritonavir plasma levels and reduce their therapeutic effect. Concomitant use contraindicated

Efavirenz, 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.

Efavirenz, paclitaxel [2] ---> SmPC of [2] of EMA

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 is not recommended because efficacy may be compromised because of lower paclitaxel exposures.

Efavirenz, pemigatinib [2] ---> SmPC of [2] of EMA

In vitro studies indicate that pemigatinib induces CYP2B6. Co-administration of pemigatinib with CYP2B6 substrates (e.g. cyclophosphamide, ifosfamide, methadone, efavirenz) may decrease their exposure.

Efavirenz, pitolisant [2] ---> SmPC of [2] of EMA

With other CYP3A4, CYP2B6 (e.g. efavirenz, bupropion), CYP2C (e.g. repaglinide, phenytoin, warfarin), P-gp (e.g. dabigatran, digoxin) and UGT (e.g. morphine, paracetamol, irinotecan) substrates, caution should be made

Efavirenz, posaconazole [2] ---> SmPC of [2] of EMA

Posaconazole concentrations may be significantly lowered in combination; therefore, concomitant use with posaconazole should be avoided unless the benefit to the patient outweighs the risk

Efavirenz, prasugrel [2] ---> SmPC of [2] of EMA

This effect (weak inhibitor for CYP2B6 by prasugrel) is likely to be of clinical concern only when prasugrel is coadministered with medicinal products for which CYP2B6 is the only metabolic pathway and have a narrow therapeutic window

Efavirenz, pretomanid [2] ---> SmPC of [2] of EMA

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

Efavirenz, 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.

Efavirenz, raltegravir [2] ---> SmPC of [2] of EMA

Less potent inducers (e.g., efavirenz, nevirapine, etravirine, rifabutin, glucocorticoids, St. John's wort, pioglitazone) may be used with the recommended dose of raltegravir.

Efavirenz, ranolazine [2] ---> SmPC of [2] of EMA

The potential for inhibition of CYP2B6 has not been evaluated. Caution is advised during co-administration with CYP2B6 substrates

Efavirenz, ribociclib [2] ---> SmPC of [2] of EMA

The concomitant use of moderate CYP3A4 inducers may lead to decreased exposure and consequently a risk for impaired efficacy, in particular in patients treated with ribociclib at 400 mg or 200 mg once daily.

Efavirenz, rilpivirine [2] ---> SmPC of [2] of EMA

The co-administration of rilpivirine with another non-nucleoside reverse transcriptase inhibitor is not recommended

Efavirenz, 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

Efavirenz, ripretinib [2] ---> SmPC of [2] of EMA

Concomitant use of QINLOCK with strong CYP3A inducers (e.g. carbamazepine, phenytoin, rifampicin, phenobarbital and St. John's wort) and moderate CYP3A inducers (e.g. efavirenz and etravirine) must therefore be avoided.

Efavirenz, ritonavir [2] ---> SmPC of [2] of EMA

Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.

Efavirenz, rolapitant [2] ---> SmPC of [2] of EMA

The effect of moderate inducers (e.g. efavirenz, rifabutin) is not established; therefore, the use of rolapitant in patients already given a moderate inducer is not recommended

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

The CYP3A4 enzyme induction by efavirenz may decrease the exposition of simeprevir. It is not recommended to co-administer OLYSIO with efavirenz as co-administration may result in loss of therapeutic effect of simeprevir.

Efavirenz, sofosbuvir [2] ---> SmPC of [2] of EMA

No dose adjustment of sofosbuvir or tacrolimus is required when sofosbuvir and efavirenz are used concomitantly.

Efavirenz, sofosbuvir/velpatasvir [2] ---> SmPC of [2] of EMA

Medicinal products that are moderate P-gp inducers and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentration leading to reduced therapeutic effect of Epclusa.

Efavirenz, sofosbuvir/velpatasvir/voxilaprevir [2] ---> SmPC of [2] of EMA

Medicinal products that are moderate P-gp or moderate CYP inducers (e.g. oxcarbazepine, rifapentine, modafinil or efavirenz) may decrease sofosbuvir, velpatasvir and/or voxilaprevir plasma concentrations leading to reduced therapeutic effect of Vosevi.

Efavirenz, sparsentan [2] ---> SmPC of [2] of EMA

Concomitant use with a moderate or strong CYP3A inducer decreases sparsentan exposure, which may reduce the efficacy of sparsentan. Therefore, co-administration with a moderate or strong CYP3A inducer is not recommended.

Efavirenz, tamsulosin

The CYP3A4 inhibition may increase plasma concentrations of tamsulosin

Efavirenz, telithromycin

The co-administration may decrease the plasma levels of telithromycin

Efavirenz, temsirolimus

May decrease the plasma levels of temsirolimus

Efavirenz, tenofovir alafenamide [2] ---> SmPC of [2] of EMA

No dose adjustment of Vemlidy or efavirenz is required.

Efavirenz, thiotepa [2] ---> SmPC of [2] of EMA

Thiotepa is a weak inhibitor for CYP2B6, and may thereby potentially increase plasma levels of substances metabolised via CYP2B6. Co-administration of thiotepa may lead to decreased concentrations of the active 4-OHCP.

Efavirenz, tipranavir [2] ---> SmPC of [2] of EMA

No clinically significant interaction is observed. No dosage adjustment necessary

Efavirenz, tolterodine

May increase the plasma levels of tolterodine

Efavirenz, tramadol

May decrease the plasma levels of tramadol

Efavirenz, trazodone

The inhibition and induction of CYP3A4 may alter trazodone efficacy and toxicity

Efavirenz, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

Efavirenz, vadadustat [2] ---> SmPC of [2] of EMA

Vadadustat is an in vitro inducer of CYP2B6. Co-administration of vadadustat with sensitive substrates of CYP2B6 (e.g. efavirenz, bupropion) may alter their pharmacokinetics

Efavirenz, valganciclovir [2] ---> SmPC of [2] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Efavirenz, 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.

Efavirenz, voclosporine [2] ---> SmPC of [2] of EMA

Strong and moderate CYP3A4 inducers (e.g., carbamazepine, phenobarbital, rifampicin, St John's Wort, efavirenz) are not recommended to be dosed concomitantly with voclosporin (see section 4.4).

Efavirenz, voriconazole [2] ---> SmPC of [2] of EMA

Voriconazole may be coadministered with efavirenz if the voriconazole maintenance dose is increased to 400 mg BID and the efavirenz dose is decreased to 300 mg QD. When voriconazole treatment is stopped, the initial dose of efavirenz should be restored

Efavirenz, 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

Efavirenz/atazanavir/ritonavir, maraviroc

Increased AUC y Cmax of maraviroc

Efavirenz/darunavir/ritonavir, maraviroc

Increased AUC y Cmax of maraviroc

            CONTRAINDICATIONS of Efavirenz (Efavirenz Teva)

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

            - Patients with severe hepatic impairment (Child Pugh Class C) (see section 5.2).

            - Co-administration with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).

            - Co-administration with elbasvir (EBR) and grazoprevir (GZR) due to the potential for significant decreases in plasma concentrations of EBR and GZR (see section 4.5).

            - Herbal preparations containing St. John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).

            Patients with:

              -a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.

              -a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.

              - severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.

            Patients taking drugs that are known to prolong the QTc interval (proarrhythmic).

              -antiarrhythmics of classes IA and III,

              -neuroleptics, antidepressive agents,

              -certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents,

              -certain non-sedating antihistamines (terfenadine, astemizole),

              -cisapride,

              -flecainide,

              -certain antimalarials,

              -methadone.

            https://www.ema.europa.eu/en/documents/product-information/efavirenz-teva-epar-product-information_en.pdf 03/03/2023

Other trade names: Stocrin, Sustiva,

Efavirenz/emtricitabine/tenofovir disoproxil (Atripla)

Ability to drive, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Dizziness has been reported during treatment with efavirenz, emtricitabine and tenofovir disoproxil fumarate. Efavirenz may also cause impaired concentration and/or somnolence.

Acenocoumarol, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Interaction not studied. Plasma concentrations and effects of warfarin or acenocoumarol are potentially increased or decreased by efavirenz. Dose adjustment of warfarin or acenocoumarol may be required when co-administered with Atripla.

Adefovir dipivoxil, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Atripla should not be administered concomitantly with adefovir dipivoxil or with medicinal products containing tenofovir alafenamide.

Aldesleukin, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.

Aminoglycoside antibiotics, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.

Amphotericin B, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.

Antidepressants, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Atripla is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes

Antifungals, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Atripla is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes

Artemether/lumefantrine, efavirenz ---> SmPC of [efavirenz/emtricitabine/tenofovir disoproxil] of EMA

Efavirenz, strong CYP3A4 inductor, may decrease the plasma concentrations of artemether and lumefantrine

Artemether/lumefantrine, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Since decreased concentrations of artemether, dihydroartemisinin, or lumefantrine may result in a decrease of antimalarial efficacy, caution is recommended when Atripla and artemether/lumefantrine tablets are co-administered.

Astemizole, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Atazanavir/ritonavir, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Insufficient data are available to make a dosing recommendation for atazanavir/ritonavir in combination with Atripla. Therefore co-administration of atazanavir/ritonavir and Atripla is not recommended (see Table 1).

Atorvastatin, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Cholesterol levels should be periodically monitored. Dosage adjustments of atorvastatin may be required when co-administered with Atripla

Atovaquone/proguanil, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Concomitant administration of atovaquone/proguanil with Atripla should be avoided whenever possible.

Bepridil, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Boceprevir, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Plasma trough concentrations of boceprevir were decreased when administered with efavirenz, a component of Atripla. The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.

Breast-feeding, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Atripla should not be used during breast-feeding. As a general rule, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV to the infant.

Buprenorphine/naloxone, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Despite the decrease in buprenorphine exposure, no patients exhibited withdrawal symptoms. Dose adjustment of buprenorphine may not be necessary when co-administered with Atripla.

Bupropion, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC 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.

Cannabinoid test, efavirenz ---> SmPC of [efavirenz/emtricitabine/tenofovir disoproxil] of EMA

Efavirenz does not bind to cannabinoid receptors. False-positive urine cannabinoid test results have been reported with some screening assays in uninfected and HIV infected subjects receiving efavirenz.

Cannabinoid test, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Efavirenz does not bind to cannabinoid receptors. False-positive urine cannabinoid test results have been reported with some screening assays in uninfected and HIV infected subjects receiving efavirenz.

Carbamazepine, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Decrease in carbamazepine concentrations: CYP3A4 induction; decrease in efavirenz concentrations: CYP3A4 and CYP2B6 induction

Cidofovir, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Due to similarities with emtricitabine, the fixed combination should not be administered concomitantly with other cytidine analogues

Cisapride, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Clarithromycin, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

CYP3A4 induction. Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin. Alternatives to clarithromycin (e.g. azithromycin) may be considered.

Class IA antiarrhythmic agents, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Atripla is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes

Class III antiarrhythmic agents, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Atripla is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes

Contraceptives, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of Atripla is recommended.

Contraceptives, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives, see section 4.5) while on therapy with Atripla.

Cyclosporine, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction). The immunosuppressant is not anticipated to impact exposure of efavirenz. Dose adjustments of the immunosuppressant may be required.

Cytarabine, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Due to similarities with emtricitabine, the fixed combination should not be administered concomitantly with other cytidine analogues

Cytidine analogues, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Due to similarities with emtricitabine, the fixed combination should not be administered concomitantly with other cytidine analogues

Cytosine arabinoside, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Due to similarities with emtricitabine, the fixed combination should not be administered concomitantly with other cytidine analogues

Darunavir/ritonavir, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Increased exposition of efavirenz (CYP3A4 inhibition) and decreased exposition of darunavir (CYP3A4 induction). This combination should be used with caution.

Didanosine, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

The combination increases the systemic exposition to didanosine. Co-administration is not recommended

Dihydroergotamine, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Diltiazem, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Dose adjustments of diltiazem when co-administered with Atripla should be guided by clinical response

Efavirenz [1], efavirenz/emtricitabine/tenofovir disoproxil ---> SmPC of [1] of EMA

The fixed combination should not be administered concomitantly with products containing efavirenz unless needed for dose adjustment

Efavirenz, fossil tree ---> SmPC of [efavirenz/emtricitabine/tenofovir disoproxil] of EMA

Concomitant use of Ginkgo biloba extracts with efavirenz is not recommended

Efavirenz, metamizole ---> SmPC of [efavirenz/emtricitabine/tenofovir disoproxil] of EMA

Co-administration of efavirenz with metamizole, which is an inducer of metabolising enzymes including CYP2B6 and CYP3A4 may cause a reduction in plasma concentrations of efavirenz with potential decrease in clinical efficacy.

Efavirenz/emtricitabine/tenofovir disoproxil [1], elbasvir/grazoprevir ---> SmPC of [1] of EMA

Co-administration of Atripla with elbasvir/grazoprevir is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir

Efavirenz/emtricitabine/tenofovir disoproxil [1], emtricitabine ---> SmPC of [1] of EMA

Due to similarities with emtricitabine, the fixed combination should not be administered concomitantly with other cytidine analogues

Efavirenz/emtricitabine/tenofovir disoproxil [1], emtricitabine/tenofovir disoproxil ---> SmPC of [1] of EMA

Due to similarities with emtricitabine, the fixed combination should not be administered concomitantly with other cytidine analogues

Efavirenz/emtricitabine/tenofovir disoproxil [1], ergonovine ---> SmPC of [1] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Efavirenz/emtricitabine/tenofovir disoproxil [1], ergot derivatives ---> SmPC of [1] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Efavirenz/emtricitabine/tenofovir disoproxil [1], ergotamine ---> SmPC of [1] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Efavirenz/emtricitabine/tenofovir disoproxil [1], estrogens ---> SmPC of [1] of EMA

The enzymatic induction may decrease the plasma levels of estrogen

Efavirenz/emtricitabine/tenofovir disoproxil [1], ethinyl estradiol ---> SmPC of [1] of EMA

The enzymatic induction may decrease the plasma levels of ethinylestradiol

Efavirenz/emtricitabine/tenofovir disoproxil [1], etonogestrel ---> SmPC of [1] of EMA

A reliable method of barrier contraception must be used in addition to hormonal contraceptives

Efavirenz/emtricitabine/tenofovir disoproxil [1], felodipine ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of calcium antagonist

Efavirenz/emtricitabine/tenofovir disoproxil [1], fertility ---> SmPC of [1] of EMA

No human data on the effect of Atripla are available. Animal studies do not indicate harmful effects of efavirenz, emtricitabine or tenofovir disoproxil on fertility.

Efavirenz/emtricitabine/tenofovir disoproxil [1], flecainide ---> SmPC of [1] of EMA

Atripla is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes

Efavirenz/emtricitabine/tenofovir disoproxil [1], fluoxetine ---> SmPC of [1] of EMA

No dosage adjustment necessary.

Efavirenz/emtricitabine/tenofovir disoproxil [1], foods ---> SmPC of [1] of EMA

The administration of Atripla with food may increase efavirenz exposure and may lead to an increase in frequency of adverse reactions. It is recommended that Atripla be taken on an empty stomach, preferably at bedtime.

Efavirenz/emtricitabine/tenofovir disoproxil [1], fosamprenavir/ritonavir ---> SmPC of [1] of EMA

No clinically significant pharmacokinetic interaction. No dosage adjustment necessary.

Efavirenz/emtricitabine/tenofovir disoproxil [1], foscarnet ---> SmPC of [1] of EMA

Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.

Efavirenz/emtricitabine/tenofovir disoproxil [1], fossil tree ---> SmPC of [1] of EMA

Concomitant use of Ginkgo biloba extracts with efavirenz is not recommended

Efavirenz/emtricitabine/tenofovir disoproxil [1], gabapentin ---> SmPC of [1] of EMA

Clinically significant interactions are not expected since gabapentin is exclusively eliminated unchanged in the urine

Efavirenz/emtricitabine/tenofovir disoproxil [1], ganciclovir ---> SmPC of [1] of EMA

Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.

Efavirenz/emtricitabine/tenofovir disoproxil [1], grapefruit juice ---> SmPC of [1] of EMA

Efavirenz exposure may be increased when given with medicinal products (for example ritonavir) or food (for example, grapefruit juice) which inhibit CYP3A4 or CYP2B6 activity.

Efavirenz/emtricitabine/tenofovir disoproxil [1], immunosuppressants metabolised by CYP3A4 ---> SmPC of [1] of EMA

Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction). The immunosuppressant is not anticipated to impact exposure of efavirenz. Dose adjustments of the immunosuppressant may be required.

Efavirenz/emtricitabine/tenofovir disoproxil [1], indinavir ---> SmPC of [1] of EMA

Insufficient data are available to make a dosing recommendation for indinavir when dosed with Atripla.

Efavirenz/emtricitabine/tenofovir disoproxil [1], interleukin-2 ---> SmPC of [1] of EMA

Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.

Efavirenz/emtricitabine/tenofovir disoproxil [1], itraconazol ---> SmPC of [1] of EMA

The CYP3A4 induction decreases the plasma concentrations of itraconazol. Since no dose recommendation can be made for itraconazole when used with Atripla, an alternative antifungal treatment should be considered.

Efavirenz/emtricitabine/tenofovir disoproxil [1], lamivudine ---> SmPC of [1] of EMA

Due to similarities with emtricitabine, the fixed combination should not be administered concomitantly with other cytidine analogues

Efavirenz/emtricitabine/tenofovir disoproxil [1], levomethadone ---> SmPC of [1] of EMA

The enzymatic induction may decrease the plasma levels of levomethadone and abstinence syndrome may occur

Efavirenz/emtricitabine/tenofovir disoproxil [1], levonorgestrel ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations and the effect of levonorgestrel. A reliable method of barrier contraception must be used in addition to hormonal contraceptives

Efavirenz/emtricitabine/tenofovir disoproxil [1], lopinavir/ritonavir ---> SmPC of [1] of EMA

Higher tenofovir concentrations could potentiate tenofovir-associated adverse events, including renal disorders. Co-administration of lopinavir/ritonavir and Atripla is not recommended.

Efavirenz/emtricitabine/tenofovir disoproxil [1], lumefantrine ---> SmPC of [1] of EMA

Efavirenz, strong CYP3A4 inductor, may decrease the plasma concentrations of lumefantrine

Efavirenz/emtricitabine/tenofovir disoproxil [1], maraviroc ---> SmPC of [1] of EMA

No effect is expected.

Efavirenz/emtricitabine/tenofovir disoproxil [1], metamizole ---> SmPC of [1] of EMA

Co-administration of efavirenz with metamizole, which is an inducer of metabolising enzymes including CYP2B6 and CYP3A4 may cause a reduction in plasma concentrations of efavirenz with potential decrease in clinical efficacy.

Efavirenz/emtricitabine/tenofovir disoproxil [1], methadone ---> SmPC of [1] of EMA

Co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal. The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms.

Efavirenz/emtricitabine/tenofovir disoproxil [1], methylergonovine ---> SmPC of [1] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Efavirenz/emtricitabine/tenofovir disoproxil [1], midazolam ---> SmPC of [1] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Efavirenz/emtricitabine/tenofovir disoproxil [1], nephrotoxic substances ---> SmPC of [1] of EMA

Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product. Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2

Efavirenz/emtricitabine/tenofovir disoproxil [1], neuroleptics ---> SmPC of [1] of EMA

Atripla is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes

Efavirenz/emtricitabine/tenofovir disoproxil [1], nicardipine ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of calcium antagonist

Efavirenz/emtricitabine/tenofovir disoproxil [1], nifedipine ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of calcium antagonist

Efavirenz/emtricitabine/tenofovir disoproxil [1], non-sedating antihistamines ---> SmPC of [1] of EMA

Atripla is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes

Efavirenz/emtricitabine/tenofovir disoproxil [1], paroxetine ---> SmPC of [1] of EMA

No dosage adjustment necessary.

Efavirenz/emtricitabine/tenofovir disoproxil [1], pentamidine ---> SmPC of [1] of EMA

Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.

Efavirenz/emtricitabine/tenofovir disoproxil [1], pharmacokinetics ---> SmPC of [1] of EMA

There were no clinically significant PK interactions when efavirenz was administered with azithromycin, cetirizine, fosamprenavir/ritonavir, lorazepam, nelfinavir, zidovudine, aluminium/magnesium hydroxide antacids, famotidine or fluconazole.

Efavirenz/emtricitabine/tenofovir disoproxil [1], phenobarbital ---> SmPC of [1] of EMA

There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP isozymes with efavirenz.

Efavirenz/emtricitabine/tenofovir disoproxil [1], phenytoin ---> SmPC of [1] of EMA

There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP isozymes with efavirenz.

Efavirenz/emtricitabine/tenofovir disoproxil [1], pimozide ---> SmPC of [1] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Efavirenz/emtricitabine/tenofovir disoproxil [1], posaconazole ---> SmPC of [1] of EMA

The UDP-G induction decreases the plasma concentrations of posaconazole. Concomitant use should be avoided

Efavirenz/emtricitabine/tenofovir disoproxil [1], pravastatine ---> SmPC of [1] of EMA

Cholesterol levels should be periodically monitored. Dosage adjustments of pravastatine may be required when co-administered with Atripla

Efavirenz/emtricitabine/tenofovir disoproxil [1], pregnancy ---> SmPC of [1] of EMA

Atripla should not be used during pregnancy unless the clinical condition of the woman requires treatment with efavirenz/emtricitabine/tenofovir disoproxil fumarate.

Efavirenz/emtricitabine/tenofovir disoproxil [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Atripla is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes

Efavirenz/emtricitabine/tenofovir disoproxil [1], quinolones ---> SmPC of [1] of EMA

Atripla is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes

Efavirenz/emtricitabine/tenofovir disoproxil [1], raltegravir ---> SmPC of [1] of EMA

The induction of UGT1A1 may reduce raltegravir exposition. No dosage adjustment necessary.

Efavirenz/emtricitabine/tenofovir disoproxil [1], rifabutin ---> SmPC of [1] of EMA

The CYP3A4 induction may decrease the rifabutin exposition

Efavirenz/emtricitabine/tenofovir disoproxil [1], rifampicin ---> SmPC of [1] of EMA

The CYP3A4 and CYP2B6 induction may decrease the plasma concentrations of efavirenz. No dose adjustment of rifampicin is recommended when given with Atripla

Efavirenz/emtricitabine/tenofovir disoproxil [1], ritonavir ---> SmPC of [1] of EMA

Efavirenz exposure may be increased when given with medicinal products (for example ritonavir) or food (for example, grapefruit juice) which inhibit CYP3A4 or CYP2B6 activity.

Efavirenz/emtricitabine/tenofovir disoproxil [1], rosuvastatin ---> SmPC of [1] of EMA

Atripla and rosuvastatin can be co-administered without dose adjustment.

Efavirenz/emtricitabine/tenofovir disoproxil [1], saquinavir/ritonavir ---> SmPC of [1] of EMA

Insufficient data are available to make a dosing recommendation for saquinavir/ritonavir when dosed with Atripla. Use of Atripla in combination with saquinavir as the sole protease inhibitor is not recommended.

Efavirenz/emtricitabine/tenofovir disoproxil [1], sertraline ---> SmPC of [1] of EMA

CYP3A4 induction. When co-administered with Atripla, sertraline dose increases should be guided by clinical response.

Efavirenz/emtricitabine/tenofovir disoproxil [1], simeprevir ---> SmPC of [1] of EMA

Concomitant administration of simeprevir with efavirenz (CYP3A induction) resulted in significantly decreased plasma concentrations of simeprevir, which may result in loss of therapeutic effect of simeprevir. Co-administration is not recommended.

Efavirenz/emtricitabine/tenofovir disoproxil [1], simvastatine ---> SmPC of [1] of EMA

Cholesterol levels should be periodically monitored. Dosage adjustments of simvastatine may be required when co-administered with Atripla

Efavirenz/emtricitabine/tenofovir disoproxil [1], sirolimus ---> SmPC of [1] of EMA

Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction). The immunosuppressant is not anticipated to impact exposure of efavirenz. Dose adjustments of the immunosuppressant may be required.

Efavirenz/emtricitabine/tenofovir disoproxil [1], sofosbuvir/velpatasvir ---> SmPC of [1] of EMA

Co-administration of Atripla and sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended

Efavirenz/emtricitabine/tenofovir disoproxil [1], sofosbuvir/velpatasvir/voxilaprevir ---> SmPC of [1] of EMA

Co-administration of Atripla and sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended

Efavirenz/emtricitabine/tenofovir disoproxil [1], tacrolimus ---> SmPC of [1] of EMA

Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction). The immunosuppressant is not anticipated to impact exposure of efavirenz. Dose adjustments of the immunosuppressant may be required.

Efavirenz/emtricitabine/tenofovir disoproxil [1], telaprevir ---> SmPC of [1] of EMA

CYP3A induction by efavirenz. If Atripla and telaprevir are co-administered, telaprevir 1,125 mg q8h should be used.

Efavirenz/emtricitabine/tenofovir disoproxil [1], tenofovir alafenamide ---> SmPC of [1] of EMA

Atripla should not be administered concomitantly with adefovir dipivoxil or with medicinal products containing tenofovir alafenamide.

Efavirenz/emtricitabine/tenofovir disoproxil [1], tenofovir disoproxil ---> SmPC of [1] of EMA

The fixed combination should not be administered concomitantly with other medicinal products containing the components, emtricitabine or tenofovir disoproxil fumarate

Efavirenz/emtricitabine/tenofovir disoproxil [1], terfenadine ---> SmPC of [1] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Efavirenz/emtricitabine/tenofovir disoproxil [1], triazolam ---> SmPC of [1] of EMA

The combination is contraindicated since inhibition of metabolism by efavirenz (CYP3A4 inhibitor) may lead to serious, life-threatening events

Efavirenz/emtricitabine/tenofovir disoproxil [1], tubular secretion ---> SmPC of [1] of EMA

Co-administration of medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.

Efavirenz/emtricitabine/tenofovir disoproxil [1], valproic acid ---> SmPC of [1] of EMA

Atripla and valproic acid can be co-administered without dose adjustment. Patients should be monitored for seizure control.

Efavirenz/emtricitabine/tenofovir disoproxil [1], vancomycin ---> SmPC of [1] of EMA

Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.

Efavirenz/emtricitabine/tenofovir disoproxil [1], verapamil ---> SmPC of [1] of EMA

Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of calcium antagonist

Efavirenz/emtricitabine/tenofovir disoproxil [1], vigabatrin ---> SmPC of [1] of EMA

Clinically significant interactions are not expected since vigabatrin is exclusively eliminated unchanged in the urine

Efavirenz/emtricitabine/tenofovir disoproxil [1], voriconazole ---> SmPC of [1] of EMA

Co-administration of standard doses of efavirenz and voriconazole is contraindicated.

Efavirenz/emtricitabine/tenofovir disoproxil [1], warfarin ---> SmPC of [1] of EMA

Interaction not studied. Plasma concentrations and effects of warfarin or acenocoumarol are potentially increased or decreased by efavirenz. Dose adjustment of warfarin or acenocoumarol may be required when co-administered with Atripla.

Efavirenz/emtricitabine/tenofovir disoproxil [1], women of childbearing potential ---> SmPC of [1] of EMA

Pregnancy should be avoided in women receiving Atripla. Women of childbearing potential should undergo pregnancy testing before initiation of Atripla.

Efavirenz/emtricitabine/tenofovir disoproxil [1], zalcitabine ---> SmPC of [1] of EMA

Due to similarities with emtricitabine, the fixed combination should not be administered concomitantly with other cytidine analogues

Efavirenz/emtricitabine/tenofovir disoproxil, emtricitabine/rilpivirine/tenofovir disoproxil [2] ---> SmPC of [2]

Due to similarities with emtricitabine, the fixed combination should not be administered concomitantly with other cytidine analogues

Efavirenz/emtricitabine/tenofovir disoproxil, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration with efavirenz may lead to reduced therapeutic effect of Maviret and is not recommended.

Efavirenz/emtricitabine/tenofovir disoproxil, ledipasvir/sofosbuvir [2] ---> SmPC of [2] of EMA

No dose adjustment of Harvoni or efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is required.

Efavirenz/emtricitabine/tenofovir disoproxil, sofosbuvir/velpatasvir [2] ---> SmPC of [2] of EMA

Co-administration of Epclusa with efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is expected to decrease the concentration of velpatasvir. Co-administration of Epclusa with efavirenz-containing regimens is not recommended

Efavirenz/emtricitabine/tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir [2] ---> SmPC of [2] of EMA

Co-administration of Vosevi with efavirenz/emtricitabine/tenofovir disoproxil fumarate is not recommended (see section 4.4).

Mitochondrial dysfunction following exposure in utero, nucleoside analogues ---> SmPC of [efavirenz/emtricitabine/

Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.

Mitochondrial dysfunction following exposure in utero, nucleotide analogues ---> SmPC of [efavirenz/emtricitabine/

Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.

NSAID, tenofovir disoproxil ---> SmPC of [efavirenz/emtricitabine/tenofovir disoproxil] of EMA

Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil fumarate and with risk factors for renal dysfunction.

            CONTRAINDICATIONS of Efavirenz/emtricitabine/tenofovir disoproxil (Atripla)

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

            - Severe hepatic impairment (CPT, Class C)

            - Co-administration with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine). Competition for cytochrome P450 (CYP) 3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening adverse reactions (for example, cardiac arrhythmias, prolonged sedation or respiratory depression) (see section 4.5).

            - Co-administration with elbasvir/grazoprevir due to the expected significant decreases in plasma concentrations of elbasvir and grazoprevir. This effect is due to induction of CYP3A4 or P-gp by efavirenz and may result in loss of therapeutic effect of elbasvir/grazoprevir (see section 4.5).

            - Co-administration with voriconazole. Efavirenz significantly decreases voriconazole plasma concentrations while voriconazole also significantly increases efavirenz plasma concentrations. Since Atripla is a fixed-dose combination product, the dose of efavirenz cannot be altered (see section 4.5).

            - Co-administration with herbal preparations containing St. John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).

            Administration to patients with:

            - a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.

            - a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.

            - severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.

            - Co-administration with drugs that are known to prolong the QTc interval (proarrhythmic).

            These drugs include:

            - antiarrhythmics of classes IA and III,

            - neuroleptics, antidepressive agents,

            - certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents,

            - certain non-sedating antihistamines (terfenadine, astemizole),

            - cisapride,

            - flecainide,

            - certain antimalarials,

            - methadone (see sections 4.4, 4.5 and 5.1).

            https://www.ema.europa.eu/en/documents/product-information/atripla-epar-product-information_en.pdf 21/01/2022 (withdrawn)

Other trade names: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva,

Efbemalenograstim alfa (Ryzneuta)

Breast-feeding, efbemalenograstim alfa [2] ---> SmPC of [2] of EMA

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

Chemotherapy, efbemalenograstim alfa [2] ---> SmPC of [2] of EMA

Concomitant use of Ryzneuta with chemotherapy (i.e. administration on the same day) has been shown to potentiate myelosuppression.

Cytotoxic chemotherapy, efbemalenograstim alfa [2] ---> SmPC of [2] of EMA

Efbemalenograstim alfa should be administered at least 24 hours after administration of cytotoxic chemotherapy, and at least 14 days before the next dose of chemotherapy.

Efbemalenograstim alfa [1], fertility ---> SmPC of [1] of EMA

Efbemalenograstim alfa did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 2.2 times higher than the recommended human dose (based on body surface area) (see section 5.3).

Efbemalenograstim alfa [1], hemopoietic growth factors ---> SmPC of [1] of EMA

Possible interactions with other haematopoietic growth factors and cytokines have not been specifically investigated in clinical trials.

Efbemalenograstim alfa [1], lithium ---> SmPC of [1] of EMA

The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated. There is no evidence that such an interaction would be harmful.

Efbemalenograstim alfa [1], nitrosourea ---> SmPC of [1] of EMA

The safety and efficacy of Ryzneuta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression, e.g. nitrosoureas.

Efbemalenograstim alfa [1], pregnancy ---> SmPC of [1] of EMA

Ryzneuta is not recommended during pregnancy and in women of childbearing potential not using contraception.

             CONTRAINDICATIONS of Efbemalenograstim alfa (Ryzneuta)

             - 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/ryzneuta-epar-product-information_en.pdf 13/05/2024      

Efgartigimod alfa (Vyvgart)

Breast-feeding, efgartigimod alfa [2] ---> SmPC of [2] of EMA

Treatment of lactating women with efgartigimod alfa should only be considered if the clinical benefit outweighs the risks.

Efgartigimod alfa [1], fertility ---> SmPC of [1] of EMA

Animal studies showed no impact of efgartigimod alfa on male and female fertility parameters

Efgartigimod alfa [1], interactions ---> SmPC of [1] of EMA

Efgartigimod alfa may decrease concentrations of compounds that bind to the human neonatal Fc Receptor (FcRn), i.e., immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass.

Efgartigimod alfa [1], plasma exchange ---> SmPC of [1] of EMA

Plasma exchange, immunoadsorption, and plasmapheresis may reduce circulating levels of efgartigimod alfa.

Efgartigimod alfa [1], pregnancy ---> SmPC of [1] of EMA

Treatment of pregnant women with Vyvgart should only be considered if the clinical benefit outweighs the risks.

Efgartigimod alfa [1], vaccinations ---> SmPC of [1] of EMA

For patients that are on treatment, vaccination with live or live-attenuated vaccines is not recommended

            CONTRAINDICATIONS of Efgartigimod alfa (Vyvgart)

            - 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/vyvgart-epar-product-information_en.pdf 30/07/2025 

Eflornithine (Vaniqa 11.5% cream)

Breast-feeding, eflornithine [2] ---> SmPC of [2] of EMA

Women should not use Vaniqa whilst breastfeeding.

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

There are no data available.

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

Women who are pregnant or planning pregnancy should use an alternative means to manage facial hair.

             CONTRAINDICATIONS of Eflornithine (Vaniqa 11.5% cream)   

             - 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/vaniqa-epar-product-information_en.pdf 27/11/2024      

Efmoroctocog alfa (Elocta)

Breast-feeding, efmoroctocog alfa [2] ---> SmPC of [2] of EMA

Factor VIII should be used during pregnancy and lactation only if clearly indicated.

Efmoroctocog alfa [1], pregnancy ---> SmPC of [1] of EMA

Factor VIII should be used during pregnancy and lactation only if clearly indicated.

            CONTRAINDICATIONS of Efmoroctocog alfa (Elocta)

            - 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/elocta-epar-product-information_en.pdf 16/07/2024

Eftrenonacog alfa (Alprolix)

Breast-feeding, eftrenonacog alfa [2] ---> SmPC of [2] of EMA

Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available. Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.

Eftrenonacog alfa [1], fertility ---> SmPC of [1] of EMA

There are no fertility data available. No fertility studies have been conducted in animals with ALPROLIX.

Eftrenonacog alfa [1], pregnancy ---> SmPC of [1] of EMA

Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available. Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.

            CONTRAINDICATIONS of Eftrenonacog alfa (Alprolix)

            - 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/alprolix-epar-product-information_en.pdf 05/06/2024             

Elacestrant (Orserdu)

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

Since fatigue, asthenia, and insomnia have been reported in some patients taking elacestrant (see section 4.8), caution should be observed by patients who experience those adverse reactions when driving or operating machinery.

Aprepitant, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

BCRP substrates, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant use of ORSERDU with other BCRP substrates may increase their concentrations, which may increase the adverse reactions associated with the BCRP substrates.

Bosentan, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

Breast-feeding, elacestrant [2] ---> SmPC of [2] of EMA

Because of the potential for serious adverse reactions in the breast-fed infant, it is recommended that lactating women should not breast-feed during treatment with ORSERDU and one week after the last dose of ORSERDU.

Carbamazepine, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inductors should be avoided, which may decrease elacestrant activity

Cenobamate, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

Ciprofloxacin, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Clarithromycin, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Conivaptan, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Crizotinib, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Cyclosporine, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Dabrafenib, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

Digoxin, elacestrant [2] ---> SmPC of [2] of EMA

Co-administration of ORSERDU (345 mg, single dose) with digoxin (0.5 mg, single dose) increased digoxin exposure by 27% for Cmax and 13% for AUC. Digoxin administration should be monitored and its dose reduced as necessary.

Diltiazem, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Dronedarone, elacestrant [2] ---> SmPC of [2] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Efavirenz [1], elacestrant ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

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

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

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

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

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

Based on findings from animal studies (see section 5.3) and its mechanism of action, ORSERDU may impair fertility in females and males of reproductive potential.

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

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], fluvoxamine ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], grapefruit ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], grapefruit juice ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], imatinib ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], indinavir ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], isavuconazole ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], itraconazol ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

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

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], lopinavir/ritonavir ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], lorlatinib ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

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

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

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

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], nefazodone ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], nelfinavir ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], OATP2B1 inhibitor ---> SmPC of [1] of EMA

As it cannot be excluded that the coadministration of OATP2B1 inhibitors may increase the exposure of elacestrant, which may increase the risk of adverse reactions, caution is recommended in case of concomitant use of ORSERDU with OATP2B1 inhibitors.

Elacestrant [1], P-glycoprotein substrates ---> SmPC of [1] of EMA

Concomitant use of ORSERDU with other P-gp substrates may increase their concentrations, which may increase the adverse reactions associated with the P-gp substrates.

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

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

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

Concomitant administration of ORSERDU with strong CYP3A4 inductors should be avoided, which may decrease elacestrant activity

Elacestrant [1], posaconazole ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

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

ORSERDU should not be used during pregnancy or in women of childbearing potential not using contraception.

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

ORSERDU can cause foetal harm when administered to pregnant women. Females of reproductive potential should be advised to use effective contraception during treatment with ORSERDU and one week after the last dose.

Elacestrant [1], primidone ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

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

Concomitant administration of ORSERDU with strong CYP3A4 inductors should be avoided, which may decrease elacestrant activity

Elacestrant [1], rosuvastatin ---> SmPC of [1] of EMA

Co-administration of ORSERDU (345 mg, single dose) with rosuvastatin (20 mg, single dose) increased rosuvastatin exposure by 45% for Cmax and 23% for AUC. Rosuvastatin administration should be monitored and its dose reduced as necessary.

Elacestrant [1], saquinavir ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], sotorasib ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inductors should be avoided, which may decrease elacestrant activity

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

Concomitant administration of ORSERDU with strong CYP3A4 inductors should be avoided, which may decrease elacestrant activity

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

Concomitant administration of ORSERDU with strong CYP3A4 inductors should be avoided, which may decrease elacestrant activity

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

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], telaprevir ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], telithromycin ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], thromboembolic events ---> SmPC of [1] of EMA

Thromboembolic events are commonly observed in patients with advanced breast cancer and have been observed in clinical studies with ORSERDU (see section 4.8). This should be taken into consideration when prescribing ORSERDU to patients at risk.

Elacestrant [1], tofisopam ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], verapamil ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

Elacestrant [1], voriconazole ---> SmPC of [1] of EMA

Concomitant administration of ORSERDU with strong CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions

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

Females of reproductive potential should be advised to use effective contraception during treatment with ORSERDU and one week after the last dose.

            CONTRAINDICATIONS of Elacestrant (Orserdu)     

            - 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/orserdu-epar-product-information_en.pdf 03/03/2025             

Eladocagene exuparvovec (Upstaza)

Breast-feeding, eladocagene exuparvovec [2] ---> SmPC of [2] of EMA

It is unknown whether eladocagene exuparvovec is excreted in human milk. Eladocagene exuparvovec is not absorbed systemically following intraputaminal administration, and no effect on the breastfed newborns/infants are anticipated.

Eladocagene exuparvovec [1], fertility ---> SmPC of [1] of EMA

There are no clinical or nonclinical data available regarding the effect of eladocagene exuparvovec on fertility.

Eladocagene exuparvovec [1], pregnancy ---> SmPC of [1] of EMA

There are no data from the use of eladocagene exuparvovec in pregnant women.

Eladocagene exuparvovec [1], vaccinations ---> SmPC of [1] of EMA

Vaccination schedule should proceed as normal.

            CONTRAINDICATIONS of Eladocagene exuparvovec (Upstaza)

            - Proper aseptic techniques should always be used for the preparation and infusion of Upstaza.

            https://www.ema.europa.eu/en/documents/product-information/upstaza-epar-product-information_en.pdf 26/03/2024

Elafibranor (Iqirvo)

Breast-feeding, elafibranor [2] ---> SmPC of [2] of EMA

Ein Risiko für das gestillte Kind kann nicht ausgeschlossen werden. Elafibranor soll nicht während der Stillzeit angewendet werden, und bis mindestens 3 Wochen nach der letzten Dosis von Elafibranor soll nicht gestillt werden.

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

No human data on the effect of elafibranor on fertility are available. Animal studies do not indicate any direct or indirect effects on fertility or the ability to reproduce (see section 5.3).

Elafibranor [1], medicinal products ---> SmPC of [1] of EMA

Based on in vitro and in vivo studies, no clinically relevant drug-drug interaction is expected by co-administering elafibranor with any other medicinal products (see section 5.2).

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

Elafibranor is contraindicated during pregnancy (see section 4.3). If a patient becomes pregnant, treatment with elafibranor should be discontinued.

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

These women have to use effective contraception during and up to at least 3 weeks following the final dose of elafibranor. The pregnancy status of patients of childbearing potential should be checked prior to initiation of elafibranor treatment

            CONTRAINDICATIONS of Elafibranor (Iqirvo)     

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

            - Known or suspected pregnancy and in women of childbearing age who do not use contraception (see section 4.6).             

            https://www.ema.europa.eu/en/documents/product-information/iqirvo-epar-product-information_en.pdf 20/09/2024             

Elbasvir/grazoprevir (Zepatier)

Abacavir, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

Ability to drive, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Patients should be informed that fatigue has been reported during treatment with ZEPATIER

Aluminium hydroxide, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

Antacids, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

Atazanavir, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Co-administration of REYATAZ with grazoprevir-containing products is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations

Atazanavir/ritonavir, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Combination of OATP1B and CYP3A inhibition. Co-administration is contraindicated.

Atorvastatin, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Primarily due to intestinal BCRP inhibition. The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.

BCRP substrates, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Elbasvir and grazoprevir are inhibitors of the drug transporter BCRP at the intestinal level in humans and may increase plasma concentrations of co-administered BCRP substrates.

Bosentan, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

CYP3A or P-gp induction. Co-administration is contraindicated.

Breast-feeding, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

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

Buprenorphine/naloxone, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

Calcineurin inhibitors, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Therefore, close monitoring and potential dose adjustment of CYP3A substrates with a narrow therapeutic index (e.g., calcineurin inhibitors) may be required during therapy, as drug levels may change (see Table 2).

Calcium acetate, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

Calcium carbonate, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

Carbamazepine, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

CYP3A or P-gp induction. Co-administration is contraindicated.

Cyclosporine, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Due in part to OATP1B and CYP3A inhibition. Co-administration is contraindicated.

CYP isoform, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Based on in vitro data, a potential for GZR to inhibit BSEP cannot be excluded. Multiple-dose administration of elbasvir or grazoprevir is unlikely to induce the metabolism of medicinal products metabolised by CYP isoforms based on in vitro data.

CYP3A substrates with narrow therapeutic index, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Therefore, close monitoring and potential dose adjustment of CYP3A substrates with a narrow therapeutic index (e.g., calcineurin inhibitors) may be required during therapy, as drug levels may change (see Table 2).

CYP3A4 substrates, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Grazoprevir's weak inhibition of CYP3A may increase levels ofCYP3A substrates.

Dabigatran etexilate, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

P-gp inhibition. Concentrations of dabigatran may increase when co-administered with elbasvir, with possible increased bleeding risk. Clinical and laboratory monitoring is recommended.

Darunavir/cobicistat, elbasvir/grazoprevir ---> SmPC of [darunavir] of EMA

Concomitant use of boosted PREZISTA and elbasvir/grazoprevir is contraindicated

Darunavir/ritonavir, elbasvir/grazoprevir ---> SmPC of [darunavir] of EMA

Concomitant use of boosted PREZISTA and elbasvir/grazoprevir is contraindicated

Darunavir/ritonavir, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Combination of OATP1B and CYP3A inhibition. Co-administration is contraindicated.

Digoxin, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Elbasvir has minimal intestinal P-gp inhibition in humans, and does not result in clinically relevant increases in concentrations of digoxin (a P-gp substrate), with an 11% increase in plasma AUC. No dose adjustment is required.

Dolutegravir, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

Doravirine [1], elbasvir/grazoprevir ---> SmPC of [1] of EMA

No dose adjustment is required.

Doravirine/lamivudine/tenofovir disoproxil [1], elbasvir/grazoprevir ---> SmPC of [1] of EMA

No dose adjustment is required.

Efavirenz, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA

Co-administration is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir. This loss is due to significant decreases in elbasvir and grazoprevir plasma concentrations caused by CYP3A4 induction.

Efavirenz/emtricitabine/tenofovir disoproxil [1], elbasvir/grazoprevir ---> SmPC of [1] of EMA

Co-administration of Atripla with elbasvir/grazoprevir is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir

Elbasvir/grazoprevir [1], elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil ---> SmPC of [1] of EMA

CYP3A and OATP1B inhibition. Co-administration with ZEPATIER is contraindicated.

Elbasvir/grazoprevir [1], emtricitabine ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], entecavir ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], enzyme ---> SmPC of [1] of EMA

Based on in vitro data, clinically significant interactions with ZEPATIER as an inhibitor of other CYP enzymes, UGT1A1, esterases (CES1, CES2, and CatA), OAT1, OAT3, and OCT2 are not expected.

Elbasvir/grazoprevir [1], ethinyl estradiol/levonorgestrel ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], etravirine ---> SmPC of [1] of EMA

CYP3A or P-gp induction. Co-administration is contraindicated.

Elbasvir/grazoprevir [1], famotidine ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], fertility ---> SmPC of [1] of EMA

Animal studies do not indicate harmful effects of elbasvir or grazoprevir on fertility at elbasvir and grazoprevir exposures higher than the exposure in humans at the recommended clinical dose (see section 5.3).

Elbasvir/grazoprevir [1], fluvastatin ---> SmPC of [1] of EMA

Primarily due to intestinal BCRP inhibition. The dose of fluvastatin, lovastatin, or simvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.

Elbasvir/grazoprevir [1], foods ---> SmPC of [1] of EMA

Elbasvir/grazoprevir may be taken without regard to food.

Elbasvir/grazoprevir [1], H2 antagonists ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], inhibit the bile salt export pump ---> SmPC of [1] of EMA

Based on in vitro data, a potential for GZR to inhibit BSEP cannot be excluded.

Elbasvir/grazoprevir [1], ketoconazole ---> SmPC of [1] of EMA

CYP3A inhibition. Co-administration is not recommended.

Elbasvir/grazoprevir [1], lamivudine ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], lopinavir/ritonavir ---> SmPC of [1] of EMA

Combination of OATP1B and CYP3A inhibition. Co-administration is contraindicated.

Elbasvir/grazoprevir [1], lovastatine ---> SmPC of [1] of EMA

CYP3A inhibition. The dose of fluvastatin, lovastatin, or simvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.

Elbasvir/grazoprevir [1], magnesium hydroxide ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], methadone ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], midazolam ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], modafinil ---> SmPC of [1] of EMA

CYP3A or P-gp induction. Co-administration is contraindicated.

Elbasvir/grazoprevir [1], montelukast ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], mycophenolate mofetil ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], OATP1B inhibitors ---> SmPC of [1] of EMA

Grazoprevir is a substrate of OATP1B drug transporters. Co-administration of ZEPATIER with medicinal products that inhibit OATP1B transporters is contraindicated because it may result in a significant increase in the plasma concentration of grazoprevir

Elbasvir/grazoprevir [1], P-gp inhibitors ---> SmPC of [1] of EMA

Co-administration of ZEPATIER with P-gp inhibitors is expected to have a minimal effect on the plasma concentrations of ZEPATIER.

Elbasvir/grazoprevir [1], pantoprazole ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], phenytoin ---> SmPC of [1] of EMA

CYP3A or P-gp induction. Co-administration is contraindicated.

Elbasvir/grazoprevir [1], pitavastatin ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], pravastatine ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], prednisone ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], pregnancy ---> SmPC of [1] of EMA

Because reproduction animal studies are not always predictive of human response, ZEPATIER should be used only if the potential benefit justifies the potential risk to the fetus.

Elbasvir/grazoprevir [1], proton pump inhibitors ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], raltegravir ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], rifampicin ---> SmPC of [1] of EMA

OATP1B inhibition and CYP3A induction. Co-administration is contraindicated.

Elbasvir/grazoprevir [1], rilpivirine ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], rosuvastatin ---> SmPC of [1] of EMA

Intestinal BCRP inhibition. The dose of rosuvastatin should not exceed a daily dose of 10 mg when co-administered with ZEPATIER.

Elbasvir/grazoprevir [1], saquinavir/ritonavir ---> SmPC of [1] of EMA

Combination of mechanisms including CYP3A inhibition. Co-administration is contraindicated.

Elbasvir/grazoprevir [1], sevelamer carbonate ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], simvastatine ---> SmPC of [1] of EMA

Primarily due to intestinal BCRP inhibition and CYP3A inhibition. The dose of fluvastatin, lovastatin, or simvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.

Elbasvir/grazoprevir [1], sofosbuvir ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], St. John's wort ---> SmPC of [1] of EMA

CYP3A or P-gp induction. Co-administration is contraindicated.

Elbasvir/grazoprevir [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

Elbasvir and grazoprevir are substrates of CYP3A and P-gp. Co-administration of inducers of CYP3A or P-gp with ZEPATIER is contraindicated because it may decrease elbasvir and grazoprevir plasma concentrations

Elbasvir/grazoprevir [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Co-administration of ZEPATIER with strong CYP3A inhibitors increases elbasvir and grazoprevir plasma concentrations, and co-administration is not recommended

Elbasvir/grazoprevir [1], strong P-gp inductors ---> SmPC of [1] of EMA

Elbasvir and grazoprevir are substrates of CYP3A and P-gp. Co-administration of inducers of CYP3A or P-gp with ZEPATIER is contraindicated because it may decrease elbasvir and grazoprevir plasma concentrations

Elbasvir/grazoprevir [1], sunitinib ---> SmPC of [1] of EMA

Co-administration of ZEPATIER with sunitinib may increase sunitinib concentrations leading to an increased risk of sunitinib-associated adverse events.

Elbasvir/grazoprevir [1], tacrolimus ---> SmPC of [1] of EMA

CYP3A inhibition. Frequent monitoring of tacrolimus whole blood concentrations, changes in renal function, and tacrolimus-associated adverse events upon the initiation of coadministration is recommended.

Elbasvir/grazoprevir [1], tenofovir disoproxil ---> SmPC of [1] of EMA

No dose adjustment is required.

Elbasvir/grazoprevir [1], tipranavir/ritonavir ---> SmPC of [1] of EMA

Combination of mechanisms including CYP3A inhibition. Co-administration is contraindicated.

Elbasvir/grazoprevir [1], vitamin K antagonists ---> SmPC of [1] of EMA

As liver function may change during treatment with ZEPATIER, a close monitoring of International Normalised Ratio (INR) values is recommended.

Elbasvir/grazoprevir [1], women of childbearing potential ---> SmPC of [1] of EMA

When ZEPATIER is used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded.

Elbasvir/grazoprevir, etravirine [2] ---> SmPC of [2] of EMA

Not studied. Co-administration of INTELENCE with elbasvir/grazoprevir may decrease elbasvir and grazoprevir concentrations, leading to reduced therapeutic effect of elbasvir/grazoprevir. Co-administration is contraindicated

Elbasvir/grazoprevir, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA

In patients taking products containing elbasvir or grazoprevir concomitantly with Cholib the dose of simvastatin should not exceed 20 mg/day.

Elbasvir/grazoprevir, fostemsavir [2] ---> SmPC of [2] of EMA

Temsavir may increase grazoprevir plasma levels to a clinically relevant extent caused by OATP1B1/3 inhibition by temsavir. Co-administration is not recommended as increased grazoprevir concentrations may increase the risk of ALT elevations.

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

Combinations of mechanisms including CYP3A inhibition. Concomitant administration of elbasvir/grazoprevir with Kaletra is contraindicated

             CONTRAINDICATIONS of Elbasvir/grazoprevir (Zepatier)

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

             - Patients with moderate or severe hepatic impairment (Child-Pugh B or C).  

             - Co-administration with inhibitors of organic anion transporting polypeptide 1B (OATP1B), such as rifampicin, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cobicistat or ciclosporin.

             - Co-administration with inducers of cytochrome P450 3A (CYP3A) or P-glycoprotein (P-gp), such as efavirenz, phenytoin, carbamazepine, bosentan, etravirine, modafinil or St. John's wort (Hypericum perforatum).         

             https://www.ema.europa.eu/en/documents/product-information/zepatier-epar-product-information_en.pdf 17/05/2024      

Elcatonin

Ability to drive, elcatonin

Injectable elcatonin may cause transient dizziness

Biphosphonates, elcatonin

The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lowering effect.

Breast-feeding, elcatonin

Breast-feeding is not recommended during treatment

Calcium antagonists, elcatonin

Dosage of the calcium antagonist may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations

Cardiac glycosides, elcatonin

Dosage of the cardiac glycoside may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations

Elcatonin, pregnancy

Elcatonin should be used during pregnancy only if treatment is considered absolutely essential by the physician.

Eletriptan

Ability to drive, eletriptan [2] ---> SmPC of [2] of eMC

Migraine or treatment with eletriptan may cause drowsiness or dizziness in some patients.

Breast-feeding, eletriptan [2] ---> SmPC of [2] of eMC

Eletriptan is excreted in human breast milk. Infant exposure can be minimised by avoiding breast-feeding for 24 hours after treatment.

Clarithromycin, eletriptan [2] ---> SmPC of [2] of eMC

In clinical studies with potent inhibitors of CYP3A4 significant increases in eletriptan Cmax and AUC were observed. Eletriptan should not be used together with potent CYP3A4 inhibitors

Eletriptan [1], ergot derivatives ---> SmPC of [1] of eMC

Minor though additive increases in blood pressure. It is recommended that either ergotamine-containing or ergot-type medications should not be taken within 24 hours before or after eletriptan dosing.

Eletriptan [1], ergotamine ---> SmPC of [1] of eMC

Minor though additive increases in blood pressure. It is recommended that either ergotamine-containing or ergot-type medications should not be taken within 24 hours before or after eletriptan dosing.

Eletriptan [1], erythromycin ---> SmPC of [1] of eMC

In clinical studies with potent inhibitors of CYP3A4 significant increases in eletriptan Cmax and AUC were observed. Eletriptan should not be used together with potent CYP3A4 inhibitors

Eletriptan [1], indinavir ---> SmPC of [1] of eMC

In clinical studies with potent inhibitors of CYP3A4 significant increases in eletriptan Cmax and AUC were observed. Eletriptan should not be used together with potent CYP3A4 inhibitors

Eletriptan [1], itraconazol ---> SmPC of [1] of eMC

In clinical studies with potent inhibitors of CYP3A4 significant increases in eletriptan Cmax and AUC were observed. Eletriptan should not be used together with potent CYP3A4 inhibitors

Eletriptan [1], josamycin ---> SmPC of [1] of eMC

In clinical studies with potent inhibitors of CYP3A4 significant increases in eletriptan Cmax and AUC were observed. Eletriptan should not be used together with potent CYP3A4 inhibitors

Eletriptan [1], ketoconazole ---> SmPC of [1] of eMC

In clinical studies with potent inhibitors of CYP3A4 significant increases in eletriptan Cmax and AUC were observed. Eletriptan should not be used together with potent CYP3A4 inhibitors

Eletriptan [1], methysergide ---> SmPC of [1] of eMC

Minor though additive increases in blood pressure. It is recommended that either ergotamine-containing or ergot-type medications should not be taken within 24 hours before or after eletriptan dosing.

Eletriptan [1], nelfinavir ---> SmPC of [1] of eMC

In clinical studies with potent inhibitors of CYP3A4 significant increases in eletriptan Cmax and AUC were observed. Eletriptan should not be used together with potent CYP3A4 inhibitors

Eletriptan [1], pregnancy ---> SmPC of [1] of eMC

Eletriptan should be used during pregnancy only if clearly needed.

Eletriptan [1], protease inhibitors ---> SmPC of [1] of eMC

In clinical studies with potent inhibitors of CYP3A4 significant increases in eletriptan Cmax and AUC were observed. Eletriptan should not be used together with potent CYP3A4 inhibitors

Eletriptan [1], ritonavir ---> SmPC of [1] of eMC

In clinical studies with potent inhibitors of CYP3A4 significant increases in eletriptan Cmax and AUC were observed. Eletriptan should not be used together with potent CYP3A4 inhibitors

Eletriptan [1], SNRIs ---> SmPC of [1] of eMC

There have been reports describing patients with symptoms compatible with serotonin syndrome following the use of selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans

Eletriptan [1], SSNRI ---> SmPC of [1] of eMC

There have been reports describing patients with symptoms compatible with serotonin syndrome following the use of selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans

Eletriptan [1], SSRI ---> SmPC of [1] of eMC

There have been reports describing patients with symptoms compatible with serotonin syndrome following the use of selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans

Eletriptan [1], St. John's wort ---> SmPC of [1] of eMC

Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St. John's wort (Hypericum perforatum)

Eletriptan [1], strong CYP3A4 inhibitors ---> SmPC of [1] of eMC

In clinical studies with potent inhibitors of CYP3A4 significant increases in eletriptan Cmax and AUC were observed. Eletriptan should not be used together with potent CYP3A4 inhibitors

Eletriptan, moderate CYP3A4 inhibitors

Increases in eletriptan Cmax and AUC, which are not considered clinically significant as there were no associated increases in blood pressure or adverse events compared to administering eletriptan alone.

           CONTRAINDICATIONS of Eletriptan

           RELPAX is contraindicated in patients with

           - hypersensitivity to eletriptan hydrobromide or to any of the excipients

           - severe hepatic or severe renal impairment.

           - moderately severe or severe hypertension, or untreated mild hypertension.

           - confirmed coronary heart disease, including ischaemic heart disease (angina pectoris, previous myocardial infarction or confirmed silent ischaemia), objective or subjective symptoms of ischaemic heart disease or Prinzmetal's angina.

           - significant arrhythmias or heart failure.

           - peripheral vascular disease.

           - a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).

           - administration of ergotamine, or derivatives of ergotamine (including methysergide), within 24 hr before or after treatment with eletriptan

           - concomitant administration of other 5-HT1 receptor agonists with eletriptan.

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

Eliglustat (Cerdelga)

Amiodarone, eliglustat [2] ---> SmPC of [2] of EMA

Because eliglustat is predicted to cause mild increases in ECG intervals at substantially elevated plasma concentrations, use of eliglustat should be avoided in combination with Class IA and Class III antiarrhythmic medicinal products.

Amitriptyline, eliglustat [2] ---> SmPC of [2] of EMA

Concomitant administration of eliglustat with CYP2D6 substrates may increase the exposition of these substrates. Lower doses of medicinal products that are CYP2D6 substrates may be required.

Amlodipine, eliglustat [2] ---> SmPC of [2] of EMA

Caution should be used with weak CYP3A inhibitors in poor metabolisers.

Aprepitant, eliglustat [2] ---> SmPC of [2] of EMA

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Atazanavir, eliglustat [2] ---> SmPC of [2] of EMA

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Atomoxetine, eliglustat [2] ---> SmPC of [2] of EMA

Concomitant administration of eliglustat with CYP2D6 substrates may increase the exposition of these substrates. Lower doses of medicinal products that are CYP2D6 substrates may be 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.

Breast-feeding, eliglustat [2] ---> SmPC of [2] of EMA

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

Bupropion, eliglustat [2] ---> SmPC 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

Carbamazepine, eliglustat [2] ---> SmPC of [2] of EMA

Concomitant administration of a strong CYP3A4 inducer resulted in a decrease in eliglustat exposure. Use of a strong CYP3A inducer with eliglustat is not recommended in poor, intermediate and extensive metabolisers.

Cilostazol, eliglustat [2] ---> SmPC of [2] of EMA

Caution should be used with weak CYP3A inhibitors in poor metabolisers.

Cimetidine, eliglustat [2] ---> SmPC of [2] of EMA

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Cinacalcet, eliglustat [2] ---> SmPC of [2] of EMA

It is predicted that concomitant use of moderate CYP2D6 inhibitors would increase eliglustat exposure approximately up to 4-fold. Caution should be used with moderate CYP2D6 inhibitors in intermediate and extensive metabolisers

Ciprofloxacin, eliglustat [2] ---> SmPC of [2] of EMA

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Clarithromycin, 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.

Class IA antiarrhythmic agents, eliglustat [2] ---> SmPC of [2] of EMA

Because eliglustat is predicted to cause mild increases in ECG intervals at substantially elevated plasma concentrations, use of eliglustat should be avoided in combination with Class IA and Class III antiarrhythmic medicinal products.

Class III antiarrhythmic agents, eliglustat [2] ---> SmPC of [2] of EMA

Because eliglustat is predicted to cause mild increases in ECG intervals at substantially elevated plasma concentrations, use of eliglustat should be avoided in combination with Class IA and Class III antiarrhythmic medicinal products.

Cobicistat, 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.

Colchicine, eliglustat [2] ---> SmPC of [2] of EMA

Concomitant administration of eliglustat with P-gp substrates may increase the exposition of the P-gp substrates. Lower doses of substances which are P-gp substrates may be required.

Conivaptan, 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.

CYP3A4 inhibitors, eliglustat [2] ---> SmPC of [2] of EMA

Caution should be used with weak CYP3A inhibitors in poor metabolisers.

Dabigatran, eliglustat [2] ---> SmPC of [2] of EMA

Concomitant administration of eliglustat with P-gp substrates may increase the exposition of the P-gp substrates. Lower doses of substances which are P-gp substrates may be required.

Darunavir, eliglustat [2] ---> SmPC of [2] of EMA

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Desipramine, eliglustat [2] ---> SmPC of [2] of EMA

Concomitant administration of eliglustat with CYP2D6 substrates may increase the exposition of these substrates. Lower doses of medicinal products that are CYP2D6 substrates may be required.

Dextromethorphan, eliglustat [2] ---> SmPC of [2] of EMA

Concomitant administration of eliglustat with CYP2D6 substrates may increase the exposition of these substrates. Lower doses of medicinal products that are CYP2D6 substrates may be required.

Digoxin, eliglustat [2] ---> SmPC of [2] of EMA

Concomitant administration of eliglustat with P-gp substrates may increase the exposition of the P-gp substrates. Lower doses of substances which are P-gp substrates may be required.

Diltiazem, eliglustat [2] ---> SmPC of [2] of EMA

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Dronedarone, eliglustat [2] ---> SmPC of [2] of EMA

It is predicted that concomitant use of moderate CYP2D6 inhibitors would increase eliglustat exposure approximately up to 4-fold. Caution should be used with moderate CYP2D6 inhibitors in intermediate and extensive metabolisers

Drugs primarily metabolised by CYP2D6, eliglustat [2] ---> SmPC of [2] of EMA

Concomitant administration of eliglustat with CYP2D6 substrates may increase the exposition of these substrates. Lower doses of medicinal products that are CYP2D6 substrates may be required.

Duloxetine, eliglustat [2] ---> SmPC of [2] of EMA

It is predicted that concomitant use of moderate CYP2D6 inhibitors would increase eliglustat exposure approximately up to 4-fold. Caution should be used with moderate CYP2D6 inhibitors in intermediate and extensive metabolisers

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

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

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

Effects on testes and reversible inhibition of spermatogenesis were observed in rats (see section 5.3). The relevance of these findings for humans is not known.

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

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Eliglustat [1], fluoxetine ---> SmPC of [1] 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

Eliglustat [1], fluvoxamine ---> SmPC of [1] of EMA

Caution should be used with weak CYP3A inhibitors in poor metabolisers.

Eliglustat [1], fosamprenavir ---> SmPC of [1] of EMA

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Eliglustat [1], goldenseal ---> SmPC of [1] of EMA

Caution should be used with weak CYP3A inhibitors in poor metabolisers.

Eliglustat [1], grapefruit ---> SmPC of [1] of EMA

Grapefruit products contain one or more components that inhibit CYP3A and can increase plasma concentrations of eliglustat. Consumption of grapefruit or its juice should be avoided.

Eliglustat [1], grapefruit juice ---> SmPC of [1] of EMA

Grapefruit products contain one or more components that inhibit CYP3A and can increase plasma concentrations of eliglustat. Consumption of grapefruit or its juice should be avoided.

Eliglustat [1], imatinib ---> SmPC of [1] of EMA

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Eliglustat [1], imipramine ---> SmPC of [1] of EMA

Concomitant administration of eliglustat with CYP2D6 substrates may increase the exposition of these substrates. Lower doses of medicinal products that are CYP2D6 substrates may be required.

Eliglustat [1], indinavir ---> SmPC of [1] 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.

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

Caution should be used with weak CYP3A inhibitors in poor metabolisers.

Eliglustat [1], itraconazol ---> SmPC of [1] 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.

Eliglustat [1], ketoconazole ---> SmPC of [1] 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.

Eliglustat [1], lopinavir ---> SmPC of [1] 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.

Eliglustat [1], metoprolol ---> SmPC of [1] of EMA

Concomitant administration of eliglustat with CYP2D6 substrates may increase the exposition of these substrates. Lower doses of medicinal products that are CYP2D6 substrates may be required.

Eliglustat [1], mirabegron ---> SmPC of [1] of EMA

It is predicted that concomitant use of moderate CYP2D6 inhibitors would increase eliglustat exposure approximately up to 4-fold. Caution should be used with moderate CYP2D6 inhibitors in intermediate and extensive metabolisers

Eliglustat [1], moclobemide ---> SmPC of [1] of EMA

It is predicted that concomitant use of moderate CYP2D6 inhibitors would increase eliglustat exposure approximately up to 4-fold. Caution should be used with moderate CYP2D6 inhibitors in intermediate and extensive metabolisers

Eliglustat [1], moderate CYP2D6 and CYP3A4 inhibitors ---> SmPC of [1] of EMA

Eliglustat is contraindicated in patients who are CYP2D6 intermediate or extensive metabolisers taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor

Eliglustat [1], moderate CYP2D6 and strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Eliglustat is contraindicated in patients who are CYP2D6 intermediate or extensive metabolisers taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor

Eliglustat [1], moderate CYP2D6 inhibitors ---> SmPC of [1] of EMA

It is predicted that concomitant use of moderate CYP2D6 inhibitors would increase eliglustat exposure approximately up to 4-fold. Caution should be used with moderate CYP2D6 inhibitors in intermediate and extensive metabolisers

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

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Eliglustat [1], nortriptyline ---> SmPC of [1] of EMA

Concomitant administration of eliglustat with CYP2D6 substrates may increase the exposition of these substrates. Lower doses of medicinal products that are CYP2D6 substrates may be required.

Eliglustat [1], P-glycoprotein substrates ---> SmPC of [1] of EMA

Concomitant administration of eliglustat with P-gp substrates may increase the exposition of the P-gp substrates. Lower doses of substances which are P-gp substrates may be required.

Eliglustat [1], paroxetine ---> SmPC of [1] 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

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

Concomitant administration of a strong CYP3A4 inducer resulted in a decrease in eliglustat exposure. Use of a strong CYP3A inducer with eliglustat is not recommended in poor, intermediate and extensive metabolisers.

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

Concomitant administration of a strong CYP3A4 inducer resulted in a decrease in eliglustat exposure. Use of a strong CYP3A inducer with eliglustat is not recommended in poor, intermediate and extensive metabolisers.

Eliglustat [1], posaconazole ---> SmPC of [1] 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.

Eliglustat [1], pravastatine ---> SmPC of [1] of EMA

Concomitant administration of eliglustat with P-gp substrates may increase the exposition of the P-gp substrates. Lower doses of substances which are P-gp substrates may be required.

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

As a precautionary measure, it is recommended to avoid the use of Cerdelga during pregnancy.

Eliglustat [1], quinidine ---> SmPC of [1] of EMA

Because eliglustat is predicted to cause mild increases in ECG intervals at substantially elevated plasma concentrations, use of eliglustat should be avoided in combination with Class IA and Class III antiarrhythmic medicinal products.

Eliglustat [1], ranitidine ---> SmPC of [1] of EMA

Caution should be used with weak CYP3A inhibitors in poor metabolisers.

Eliglustat [1], ranolazine ---> SmPC of [1] of EMA

Caution should be used with weak CYP3A inhibitors in poor metabolisers.

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

Concomitant administration of a strong CYP3A4 inducer resulted in a decrease in eliglustat exposure. Use of a strong CYP3A inducer with eliglustat is not recommended in poor, intermediate and extensive metabolisers.

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

Concomitant administration of a strong CYP3A4 inducer resulted in a decrease in eliglustat exposure. Use of a strong CYP3A inducer with eliglustat is not recommended in poor, intermediate and extensive metabolisers.

Eliglustat [1], ritonavir ---> SmPC of [1] 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.

Eliglustat [1], saquinavir ---> SmPC of [1] 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.

Eliglustat [1], sotalol ---> SmPC of [1] of EMA

Because eliglustat is predicted to cause mild increases in ECG intervals at substantially elevated plasma concentrations, use of eliglustat should be avoided in combination with Class IA and Class III antiarrhythmic medicinal products.

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

Concomitant administration of a strong CYP3A4 inducer resulted in a decrease in eliglustat exposure. Use of a strong CYP3A inducer with eliglustat is not recommended in poor, intermediate and extensive metabolisers.

Eliglustat [1], strong CYP2D6 and CYP3A4 inhibitors ---> SmPC of [1] of EMA

Eliglustat is contraindicated in patients who are CYP2D6 intermediate or extensive metabolisers taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor

Eliglustat [1], strong CYP2D6 and moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA

Eliglustat is contraindicated in patients who are CYP2D6 intermediate or extensive metabolisers taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor

Eliglustat [1], strong CYP2D6 inhibitors ---> SmPC of [1] 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

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

Concomitant administration of a strong CYP3A4 inducer resulted in a decrease in eliglustat exposure. Use of a strong CYP3A inducer with eliglustat is not recommended in poor, intermediate and extensive metabolisers.

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

Eliglustat is contraindicated in patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor

Eliglustat [1], telaprevir ---> SmPC of [1] 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.

Eliglustat [1], telithromycin ---> SmPC of [1] 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.

Eliglustat [1], terbinafine ---> SmPC of [1] of EMA

It is predicted that concomitant use of moderate CYP2D6 inhibitors would increase eliglustat exposure approximately up to 4-fold. Caution should be used with moderate CYP2D6 inhibitors in intermediate and extensive metabolisers

Eliglustat [1], tipranavir ---> SmPC of [1] 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.

Eliglustat [1], tricyclic antidepressant ---> SmPC of [1] of EMA

Concomitant administration of eliglustat with CYP2D6 substrates may increase the exposition of these substrates. Lower doses of medicinal products that are CYP2D6 substrates may be required.

Eliglustat [1], verapamil ---> SmPC of [1] of EMA

It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.

Eliglustat [1], voriconazole ---> SmPC of [1] 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.

            CONTRAINDICATIONS of Eliglustat (Cerdelga)   

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

            - Cerdelga is contraindicated in patients who are CYP2D6 IMs or EMs taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and patients who are CYP2D6 PMs taking a strong CYP3A inhibitor (see section 4.5).  

            - Cerdelga is contraindicated in CYP2D6 EMs with severe hepatic impairment and in CYP2D6 Ems with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor (see sections 4.2 and 5.2).   

            https://www.ema.europa.eu/en/documents/product-information/cerdelga-epar-product-information_en.pdf 16/05/2025 

Elosulfase alfa (Vimizim)

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

Dizziness was reported during elosulfase alfa infusions; if dizziness occurs after the infusion, the ability to drive and use machines may be affected.

Breast-feeding, elosulfase alfa [2] ---> SmPC of [2] of EMA

Due to lack of human data, elosulfase alfa should only be administered to breast-feeding woman if the potential benefit is considered to outweigh the potential risk to the infant.

Elosulfase alfa [1], fertility ---> SmPC of [1] of EMA

No impairment of fertility has been observed in nonclinical studies (see section 5.3) with elosulfase alfa.

Elosulfase alfa [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is preferable to avoid the use of elosulfase alfa during pregnancy, unless clearly necessary.

            CONTRAINDICATIONS of Elosulfase alfa (Vimizim)

            - Life-threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1          

            https://www.ema.europa.eu/en/documents/product-information/vimizim-epar-product-information_en.pdf 08/02/2019             

Elotuzumab (Empliciti)

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

On the basis of reported adverse reactions, Empliciti is not expected to influence the ability to drive or use machines. Patients experiencing IRRs should be advised not to drive and use machines until symptoms abate.

Breast-feeding, elotuzumab [2] ---> SmPC of [2] of EMA

Elotuzumab is not expected to be excreted into human milk. Elotuzumab will be given in combination with lenalidomide or pomalidomide and breast-feeding should be stopped because of the use of lenalidomide or pomalidomide.

Cytochrome P450, elotuzumab [2] ---> SmPC of [2] of EMA

Empliciti is not expected to be metabolised by cytochrome P450 enzymes or other drug metabolising enzymes, inhibition/induction of these enzymes by co-administered medicines is not anticipated to affect the pharmacokinetics of Empliciti.

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

Studies to evaluate the effect of elotuzumab on fertility have not been performed. Thus, the effect of elotuzumab on male and female fertility is unknown.

Elotuzumab [1], lenalidomide ---> SmPC of [1] of EMA

The Summary of Product Characteristics for lenalidomide, pomalidomide and dexamethasone used in combination with Empliciti must be consulted before starting therapy.

Elotuzumab [1], men ---> SmPC of [1] of EMA

Male patients must use effective contraception measures during and for 180 days following treatment if their partner is pregnant or of childbearing potential and not using effective contraception.

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

Empliciti should not be used during pregnancy unless the clinical condition of the woman requires treatment with elotuzumab.

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

When Empliciti is used with lenalidomide or pomalidomide there is a risk of foetal harm, including severe life-threatening human birth defects associated with these agents and the need to follow requirements regarding pregnancy avoidance

Elotuzumab [1], serum immunofixation ---> SmPC of [1] of EMA

In case of detection of additional peaks on serum immunofixation, the possibility of a biclonal gammopathy should be excluded.

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

Empliciti should not be used in women of childbearing potential, unless the clinical condition of the woman requires treatment with elotuzumab.

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

Women of childbearing potential should use effective contraception during and for 120 days following treatment.

            CONTRAINDICATIONS of Elotuzumab (Empliciti)  

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

            - The Summary of Product Characteristics for lenalidomide, pomalidomide and dexamethasone used in combination with Empliciti must be consulted before starting therapy.

            https://www.ema.europa.eu/en/documents/product-information/empliciti-epar-product-information_en.pdf  29/09/2025 

Elranatamab (Elrexfio)

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

ELREXFIO has major influence on the ability to drive and use machines. Due to the potential for ICANS, patients receiving ELREXFIO are at risk of depressed level of consciousness (see section 4.8).

Breast-feeding, elranatamab [2] ---> SmPC of [2] of EMA

A risk to the breastfed child cannot be excluded and therefore breast-feeding is not recommended during treatment with ELREXFIO and for 6 months after the last dose.

Cyclosporine, elranatamab [2] ---> SmPC of [2] of EMA

During this time period, toxicity or medicinal product concentrations should be monitored in patients who are receiving concomitant sensitive CYP substrates with a narrow therapeutic index (e.g., cyclosporine, phenytoin, sirolimus, and warfarin).

CYP450 substrates with narrow therapeutic index, elranatamab [2] ---> SmPC of [2] of EMA

During this time period, toxicity or medicinal product concentrations should be monitored in patients who are receiving concomitant sensitive CYP substrates with a narrow therapeutic index (e.g., cyclosporine, phenytoin, sirolimus, and warfarin).

Cytochrome P450, elranatamab [2] ---> SmPC of [2] of EMA

The initial release of cytokines associated with the start of ELREXFIO may suppress cytochrome P450 (CYP) enzymes.

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

There are no data on the effect of elranatamab on human fertility. Effects of elranatamab on male and female fertility have not been evaluated in animal studies.

Elranatamab [1], immunoglobulins ---> SmPC of [1] of EMA

ELREXFIO is associated with hypogammaglobulinaemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with ELREXFIO should be considered.

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

During this time period, toxicity or medicinal product concentrations should be monitored in patients who are receiving concomitant sensitive CYP substrates with a narrow therapeutic index (e.g., cyclosporine, phenytoin, sirolimus, and warfarin).

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

Based on the mechanism of action, elranatamab may cause foetal harm when administered to a pregnant woman and therefore ELREXFIO is not recommended for use during pregnancy.

Elranatamab [1], sirolimus ---> SmPC of [1] of EMA

During this time period, toxicity or medicinal product concentrations should be monitored in patients who are receiving concomitant sensitive CYP substrates with a narrow therapeutic index (e.g., cyclosporine, phenytoin, sirolimus, and warfarin).

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

Vaccination with live virus vaccines is not recommended within the 4 weeks prior to the first dose, during treatment, and at least 4 weeks after treatment.

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

During this time period, toxicity or medicinal product concentrations should be monitored in patients who are receiving concomitant sensitive CYP substrates with a narrow therapeutic index (e.g., cyclosporine, phenytoin, sirolimus, and warfarin).

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

Prior to initiating treatment, complete blood count should be performed. Any possibility of active infections and/or pregnancy in women of child-bearing potential should be ruled out (see sections 4.4 and 4.6).

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

Women of child-bearing potential should use effective contraception during treatment with ELREXFIO and for 6 months after the last dose.

             CONTRAINDICATIONS of Elranatamab (Elrexfio)                       

             - 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/elrexfio-epar-product-information_en.pdf 17/09/2025 

Eltrombopag (Revolade)

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

The clinical status of the patient and the adverse reaction profile of eltrombopag, including dizziness and lack of alertness, should be borne in mind when considering the patient's ability to perform tasks that require judgment, motor and cognitive skill

Alpelisib [1], eltrombopag ---> SmPC of [1] of EMA

Caution and monitoring for toxicity are advised during concomitant treatment with inhibitors of BCRP (e.g. eltrombopag, lapatinib, pantoprazole).

Aluminium, eltrombopag [2] ---> SmPC of [2] of EMA

Eltrombopag chelates with polyvalent cations. Eltrombopag should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations

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

Eltrombopag chelates with polyvalent cations. Eltrombopag should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations

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

When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).

BCRP substrates, eltrombopag [2] ---> SmPC of [2] of EMA

Concomitant administration of eltrombopag (OATP1B1 and BCRP inhibitor) and OATP1B1 (e.g. methotrexate) and BCRP (e.g. topotecan and methotrexate) substrates should be undertaken with caution

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.

Breast-feeding, eltrombopag [2] ---> SmPC of [2] of EMA

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

Caffeine, eltrombopag [2] ---> SmPC of [2] of EMA

No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).

Calcium, eltrombopag [2] ---> SmPC of [2] of EMA

Eltrombopag chelates with polyvalent cations. Eltrombopag should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations

Cyclosporine, eltrombopag [2] ---> SmPC of [2] of EMA

A decrease in eltrombopag exposure was observed with co-administration of 200 mg and 600 mg ciclosporin (a BCRP inhibitor)

CYP1A2 inductors, eltrombopag [2] ---> SmPC of [2] of EMA

Medicinal products that induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

CYP1A2 inhibitors, eltrombopag [2] ---> SmPC of [2] of EMA

Medicinal products that inhibit a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

CYP2C8 inductors, eltrombopag [2] ---> SmPC of [2] of EMA

Medicinal products that induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

CYP2C8 inhibitors, eltrombopag [2] ---> SmPC of [2] of EMA

Medicinal products that inhibit a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

CYP450 substrates, eltrombopag [2] ---> SmPC of [2] of EMA

No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).

Dairy products, eltrombopag [2] ---> SmPC of [2] of EMA

Eltrombopag chelates with polyvalent cations. Eltrombopag should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations

Direct acting antivirals, eltrombopag [2] ---> SmPC of [2] of EMA

Safety and efficacy have not been established in combination with direct acting antiviral agents approved for treatment of chronic hepatitis C infection.

Eltrombopag [1], enzyme inductors ---> SmPC of [1] of EMA

Medicinal products that inhibit or induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], enzyme inhibitors ---> SmPC of [1] of EMA

Medicinal products that inhibit or induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

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

Fertility was not affected in male or female rats at exposures that were comparable to those in humans. However a risk for humans cannot be ruled out (see section 5.3).

Eltrombopag [1], flurbiprofen ---> SmPC of [1] of EMA

No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).

Eltrombopag [1], fluvastatin ---> SmPC of [1] of EMA

When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).

Eltrombopag [1], fluvoxamine ---> SmPC of [1] of EMA

Medicinal products that inhibit multiple enzymes have the potential to increase eltrombopag concentrations.

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

The tablets should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products (or other calcium containing food products), or mineral supplements containing polyvalent cations

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

Eltrombopag chelates with polyvalent cations. Eltrombopag should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations

Eltrombopag [1], lopinavir/ritonavir ---> SmPC of [1] of EMA

Co-administration of eltrombopag with lopinavir/ritonavir may cause a decrease in the concentration of eltrombopag. Platelet count should be closely monitored

Eltrombopag [1], lovastatine ---> SmPC of [1] of EMA

When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).

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

Eltrombopag chelates with polyvalent cations. Eltrombopag should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations

Eltrombopag [1], medicinal products for treatment of ITP ---> SmPC of [1] of EMA

Platelet counts should be monitored when combining eltrombopag with other medicinal products for the treatment of ITP in order to avoid platelet counts outside of the recommended range

Eltrombopag [1], medicinal products for treatment of ITP ---> SmPC of [1] of EMA

Medicinal products used in the treatment of ITP in combination with eltrombopag in clinical studies included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.

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

Concomitant administration of eltrombopag (OATP1B1 and BCRP inhibitor) and OATP1B1 (e.g. methotrexate) and BCRP (e.g. topotecan and methotrexate) substrates should be undertaken with caution

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

No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).

Eltrombopag [1], milk ---> SmPC of [1] of EMA

Eltrombopag chelates with polyvalent cations. Eltrombopag should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations

Eltrombopag [1], OATP1B1 substrates ---> SmPC of [1] of EMA

Concomitant administration of eltrombopag (OATP1B1 and BCRP inhibitor) and OATP1B1 (e.g. methotrexate) and BCRP (e.g. topotecan and methotrexate) substrates should be undertaken with caution

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

No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).

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

Eltrombopag chelates with polyvalent cations. Eltrombopag should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations

Eltrombopag [1], pravastatine ---> SmPC of [1] of EMA

When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).

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

Revolade is not recommended during pregnancy.

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

QTc interval prolongation has been reported in clinical trials of patients with ITP and thrombocytopenic patients with HCV. The clinical significance of these QTc prolongation events is unknown.

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

A QTc study in healthy volunteers dosed 150 mg eltrombopag per day did not show a clinically significant effect on cardiac repolarisation.

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

Medicinal products that induce multiple enzymes have the potential to decrease eltrombopag concentrations.

Eltrombopag [1], rosuvastatin ---> SmPC of [1] of EMA

When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).

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

Eltrombopag chelates with polyvalent cations. Eltrombopag should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations

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

When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).

Eltrombopag [1], statins ---> SmPC of [1] of EMA

When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).

Eltrombopag [1], strong CYP1A2 inductors ---> SmPC of [1] of EMA

Medicinal products that induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], strong CYP1A2 inhibitors ---> SmPC of [1] of EMA

Medicinal products that inhibit a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], strong CYP2C8 inductors ---> SmPC of [1] of EMA

Medicinal products that induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], strong CYP2C8 inhibitors ---> SmPC of [1] of EMA

Medicinal products that inhibit a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], strong UGT1A1 inductors ---> SmPC of [1] of EMA

Medicinal products that induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], strong UGT1A1 inhibitors ---> SmPC of [1] of EMA

Medicinal products that inhibit a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], strong UGT1A3 inductors ---> SmPC of [1] of EMA

Medicinal products that induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], strong UGT1A3 inhibitors ---> SmPC of [1] of EMA

Medicinal products that inhibit a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], telaprevir ---> SmPC of [1] of EMA

Co-administration of a single dose of eltrombopag 200 mg with telaprevir 750 mg Q8h did not alter plasma telaprevir exposure. Dose adjustment is not required when eltrombopag is co-administered with telaprevir

Eltrombopag [1], topotecan ---> SmPC of [1] of EMA

Concomitant administration of eltrombopag (OATP1B1 and BCRP inhibitor) and OATP1B1 (e.g. methotrexate) and BCRP (e.g. topotecan and methotrexate) substrates should be undertaken with caution

Eltrombopag [1], UGT1A1 inductors ---> SmPC of [1] of EMA

Medicinal products that induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], UGT1A1 inhibitors ---> SmPC of [1] of EMA

Medicinal products that inhibit a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], UGT1A3 inductors ---> SmPC of [1] of EMA

Medicinal products that induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

Eltrombopag [1], UGT1A3 inhibitors ---> SmPC of [1] of EMA

Medicinal products that inhibit a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations

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

Revolade is not recommended in women of childbearing potential not using contraception.

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

Eltrombopag chelates with polyvalent cations. Eltrombopag should be taken at least 2 hours before or 4 hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations

Eltrombopag, ozanimod [2] ---> SmPC of [2] of EMA

The coadministration of BCRP inhibitors (e.g. ciclosporin and eltrombopag) with ozanimod is not recommended

Eltrombopag, ripretinib [2] ---> SmPC of [2] of EMA

Based on in vitro data, medicinal products that are inhibitors of BCRP (e.g. cyclosporine A, eltrombopag) should be used with caution in combination with QINLOCK, as increased plasma concentrations of ripretinib or DP-5439 may be possible.

Eltrombopag, ritonavir

Decreased plasma levels of eltrombopag

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

Inhibitors of OATP1B1 may result in mild increases in simeprevir plasma concentrations.

             CONTRAINDICATIONS of Eltrombopag (Revolade)

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

             https://www.ema.europa.eu/en/documents/product-information/revolade-epar-product-information_en.pdf 26/02/2026 

Other trade names: Eltrombopag Accord, Eltrombopag Viatris,

Eluxadoline (Truberzi)

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

Due to events of somnolence and sedation observed in clinical studies, caution should be exercised

Alfentanyl, eluxadoline [2] ---> SmPC of [2] of EMA

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

Anticholinergics, eluxadoline [2] ---> SmPC of [2] of EMA

The use of eluxadoline with other medicinal products that may cause constipation (for example anticholinergics, opioids etc) should also be avoided.

Antiretrovirals, eluxadoline [2] ---> SmPC of [2] of EMA

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

Atazanavir, eluxadoline [2] ---> SmPC of [2] of EMA

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

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

The effect on other statins which are more sensitive OATP1B1 substrates (e.g. simvastatin and atorvastatin), however, may be more pronounced.

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

The effect on other statins which are more sensitive OATP1B1 substrates (e.g. simvastatin and atorvastatin), however, may be more pronounced.

Breast-feeding, eluxadoline [2] ---> SmPC of [2] of EMA

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

Cyclosporine, eluxadoline [2] ---> SmPC of [2] of EMA

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

CYP3A4 substrates with narrow therapeutic index, eluxadoline [2] ---> SmPC of [2] of EMA

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

Cytochrome P450, eluxadoline [2] ---> SmPC of [2] of EMA

Eluxadoline is not an inducer/inhibitor of major CYP enzymes, however, eluxadoline has some potential for the metabolism based inactivation of CYP3A4.

Dihydroergotamine, eluxadoline [2] ---> SmPC of [2] of EMA

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

Drugs primarily metabolised by CYP3A4, eluxadoline [2] ---> SmPC of [2] of EMA

Systemic exposure to medicinal products metabolised by CYP3A4 may be decreased when coadministered with Eluxadoline.

Eluxadoline [1], ergotamine ---> SmPC of [1] of EMA

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

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

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

Eluxadoline [1], fentanyl ---> SmPC of [1] of EMA

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

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

No human data on the effect of eluxadoline on fertility are available. In rats, there was no effect on mating, fertility and fecundity indices (see section 5.3).

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

The tablets should be taken with food in the morning and in the evening. Patients should be instructed if they miss a dose (delay of 4 hours) to take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose.

Eluxadoline [1], gemfibrozil ---> SmPC of [1] of EMA

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

Eluxadoline [1], loperamide ---> SmPC of [1] of EMA

Chronic use of loperamide with eluxadoline should be avoided as this may increase the risk of constipation. The use of eluxadoline with other medicinal products that may cause constipation (for example anticholinergics, opioids) should also be avoided.

Eluxadoline [1], lopinavir ---> SmPC of [1] of EMA

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

Eluxadoline [1], medicinal products that cause constipation ---> SmPC of [1] of EMA

The use of eluxadoline with other medicinal products that may cause constipation (for example anticholinergics, opioids etc) should also be avoided.

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

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

Eluxadoline [1], nifedipine ---> SmPC of [1] of EMA

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

Eluxadoline [1], OATP1B1 substrates ---> SmPC of [1] of EMA

Eluxadoline increases the exposure of the co-administered OATP1B1 substrate. Caution should be exercised in patients receiving high doses of OATP1B1 substrates

Eluxadoline [1], olmesartan ---> SmPC of [1] of EMA

Other substrates potentially affected include e.g. sartans (valsartan, olmesartan).

Eluxadoline [1], opiates ---> SmPC of [1] of EMA

The use of eluxadoline with other medicinal products that may cause constipation (for example anticholinergics, opioids etc) should also be avoided.

Eluxadoline [1], pimozide ---> SmPC of [1] of EMA

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

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

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

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

Eluxadoline is a substrate of the hepatic efflux transporter MRP2. Co-administration of eluxadoline with probenecid (MRP2 inhibitor) resulted in approximately 1.4-fold increase in exposure to eluxadoline. No dose adjustment is necessary.

Eluxadoline [1], quinidine ---> SmPC of [1] of EMA

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

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

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

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

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

Eluxadoline [1], rosuvastatin ---> SmPC of [1] of EMA

Eluxadoline increases the exposure of the co-administered OATP1B1 substrate; rosuvastatin by up to 40% of the total exposure which is usually not considered to be clinically relevant.

Eluxadoline [1], rosuvastatin ---> SmPC of [1] of EMA

The effect on other statins which are more sensitive OATP1B1 substrates (e.g. simvastatin and atorvastatin), however, may be more pronounced.

Eluxadoline [1], saquinavir ---> SmPC of [1] of EMA

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

Eluxadoline [1], sartan ---> SmPC of [1] of EMA

Other substrates potentially affected include e.g. sartans (valsartan, olmesartan).

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

The effect on other statins which are more sensitive OATP1B1 substrates (e.g. simvastatin and atorvastatin), however, may be more pronounced.

Eluxadoline [1], sirolimus ---> SmPC of [1] of EMA

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

Eluxadoline [1], statins-OATP1B1 substrates ---> SmPC of [1] of EMA

The effect on other statins which are more sensitive OATP1B1 substrates (e.g. simvastatin and atorvastatin), however, may be more pronounced.

Eluxadoline [1], strong OATP1B1 inhibitors ---> SmPC of [1] of EMA

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

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

Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.

Eluxadoline [1], tipranavir ---> SmPC of [1] of EMA

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

Eluxadoline [1], valsartan ---> SmPC of [1] of EMA

Other substrates potentially affected include e.g. sartans (valsartan, olmesartan).

            CONTRAINDICATIONS of Eluxadoline (Truberzi)    

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

            - Alcoholism, alcohol abuse, alcohol addiction or chronic or acute excessive alcohol use. These patients are at increased risk for acute pancreatitis (see section 4.4).        

            - Known or suspected biliary tree and/or pancreatic duct obstruction (e.g. gallstones, tumour, periampullary duodenal diverticulum) or sphincter of Oddi disease or dysfunction. These patients are at increased risk for sphincter of Oddi spasm     

            - Patients without a gallbladder (e.g. due to cholecystectomy or agenesis). These patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm (see section 4.4).             

            - Patients on treatment with potent inhibitors of OATP1B1 (e.g. cyclosporine)    

            - A history of pancreatitis; or known or suspected structural diseases of the pancreas, including pancreatic duct obstruction. These patients are at increased risk for acute pancreatitis (see section 4.4).    

            - Hepatic impairment (Child-Pugh Class A-C). These patients are at risk for significantly increased plasma concentrations of eluxadoline (see sections 4.4 and 5.2).         

            - A history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction. These patients may be at risk for severe complications of bowel obstruction.     

            https://www.ema.europa.eu/en/documents/product-information/truberzi-epar-product-information_en.pdf 25/02/2021 (withdrawn)    

Elvitegravir (Vitekta)

Abacavir, elvitegravir [2] ---> SmPC of [2] of EMA

No dose adjustment is required when elvitegravir is co-administered with abacavir.

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

No studies on the effects of elvitegravir on the ability to drive and use machines have been performed.

Aluminium hydroxide, elvitegravir [2] ---> SmPC of [2] of EMA

Elvitegravir plasma levels are lower with antacids due to local complexation in the gastrointestinal tract. It is recommended to separate administration by at least 4 hours.

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

Elvitegravir plasma concentrations are lower with antacids due to local complexation in the gastrointestinal tract. Separate administration by at least 4 hours

Atazanavir/ritonavir, elvitegravir [2] ---> SmPC of [2] of EMA

Co-administration of elvitegravir with medicinal products that are potent inhibitors of UGT1A1/3 may result in increased elvitegravir plasma concentrations and dose modifications may be required.

Boosted protease-inhibitors, elvitegravir [2] ---> SmPC of [2] of EMA

Elvitegravir should not be used in combination with products containing pharmacokinetic boosting agents other than ritonavir.

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

Breast-feeding, elvitegravir [2] ---> SmPC of [2] of EMA

Vitekta should not be used during breastfeeding.

Buprenorphine/naloxone, elvitegravir [2] ---> SmPC of [2] of EMA

No dosage adjustment necessary.

Carbamazepine, elvitegravir [2] ---> SmPC of [2] of EMA

Co-administration of elvitegravir with medicines that are strong inducers of CYP3A is contraindicated as the expected decrease in elvitegravir plasma levels can lead to loss of therapeutic effect and possible development of resistance to elvitegravir

Darunavir/ritonavir, elvitegravir [2] ---> SmPC of [2] of EMA

Co-administration of elvitegravir with medicinal products that are potent inhibitors of UGT1A1/3 may result in increased elvitegravir plasma concentrations and dose modifications may be required.

Didanosine, elvitegravir [2] ---> SmPC of [2] of EMA

Didanosine (on an empty stomach) should be administered at least 1 hour before or 2 hours after elvitegravir (with food). Clinical monitoring is recommended.

Didanosine, elvitegravir/ritonavir ---> SmPC of [elvitegravir] of EMA

Didanosine (on an empty stomach) should be administered at least 1 hour before or 2 hours after elvitegravir (with food). Clinical monitoring is recommended.

Drugs metabolised by UGT, elvitegravir [2] ---> SmPC of [2] of EMA

Elvitegravir, UGT inductor, may decrease the plasma levels of drugs metabolized by UGT

Drugs primarily metabolised by CYP2C9, elvitegravir [2] ---> SmPC of [2] of EMA

Elvitegravir, CYP2C9 inductor, may decrease the plasma levels of drugs metabolized by CYP2C9

Efavirenz, 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

Elvitegravir [1], emtricitabine ---> SmPC of [1] of EMA

No dose adjustment is required when elvitegravir is co-administered with emtricitabine.

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

Elvitegravir, UGT inductor, may decrease the plasma levels of ethinylestradiol

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

No dose adjustment is required when elvitegravir is co-administered with etravirine.

Elvitegravir [1], famotidine ---> SmPC of [1] of EMA

No dose adjustment is required when Vitekta is co-administered with famotidine.

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

Vitekta should be taken orally, once daily with food (see section 5.2). The film-coated tablet should not be chewed or crushed.

Elvitegravir [1], gestagens ---> SmPC of [1] of EMA

The hormonal contraceptive should contain norgestimate as the progestagen or patients should use an alternative reliable method of contraception

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

No dose adjustment is required when Vitekta is co-administered with ketoconazole.

Elvitegravir [1], lopinavir/ritonavir ---> SmPC of [1] of EMA

Co-administration of elvitegravir with medicinal products that are potent inhibitors of UGT1A1/3 may result in increased elvitegravir plasma concentrations and dose modifications may be required.

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

Elvitegravir plasma levels are lower with antacids due to local complexation in the gastrointestinal tract. It is recommended to separate administration by at least 4 hours.

Elvitegravir [1], methadone ---> SmPC of [1] of EMA

No dosage adjustment necessary.

Elvitegravir [1], moderate CYP3A4 inductors ---> SmPC of [1] 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

Elvitegravir [1], multivitamin supplements ---> SmPC of [1] of EMA

Possible decrease of elvitegravir absorption. Separate administration with the multivitamin supplement by at least 4 hours

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

Co-administration of nevirapine and elvitegravir is expected to decrease elvitegravir plasma concentrations which may result in loss of therapeutic effect and possible development of resistance. Co-administration is not recommended

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

No dose adjustment is required when Vitekta is co-administered with omeprazol.

Elvitegravir [1], oral contraceptives ---> SmPC of [1] of EMA

Co-administration of elvitegravir with oral contraceptives containing progestagens other than norgestimate has not been studied and, therefore, should be avoided.

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

Co-administration of elvitegravir with medicines that are strong inducers of CYP3A is contraindicated as the expected decrease in elvitegravir plasma levels can lead to loss of therapeutic effect and possible development of resistance to elvitegravir

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

Co-administration of elvitegravir with medicines that are strong inducers of CYP3A is contraindicated as the expected decrease in elvitegravir plasma levels can lead to loss of therapeutic effect and possible development of resistance to elvitegravir

Elvitegravir [1], pravastatine ---> SmPC of [1] of EMA

No dose adjustment is required when Vitekta is co-administered with atorvastatin, fluvastatin, pitavastatin or pravastatin.

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

Vitekta should not be used during pregnancy unless the clinical condition of the woman requires treatment with elvitegravir.

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

Co-administration of elvitegravir and rifabutin is not recommended.

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

Co-administration of elvitegravir with medicines that are strong inducers of CYP3A is contraindicated as the expected decrease in elvitegravir plasma levels can lead to loss of therapeutic effect and possible development of resistance to elvitegravir

Elvitegravir [1], rilpivirine ---> SmPC of [1] of EMA

Co-administration of elvitegravir and rilpivirine is not expected to change elvitegravir plasma concentrations, therefore no dose adjustment of Vitekta is required.

Elvitegravir [1], rosuvastatin ---> SmPC of [1] of EMA

No dose adjustment is required when Vitekta is co-administered with rosuvastatin.

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

Co-administration of elvitegravir with medicines that are strong inducers of CYP3A is contraindicated as the expected decrease in elvitegravir plasma levels can lead to loss of therapeutic effect and possible development of resistance to elvitegravir

Elvitegravir [1], stavudine ---> SmPC of [1] of EMA

No dose adjustment is required when elvitegravir is co-administered with stavudine.

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

Co-administration of elvitegravir with medicines that are strong inducers of CYP3A is contraindicated as the expected decrease in elvitegravir plasma levels can lead to loss of therapeutic effect and possible development of resistance to elvitegravir

Elvitegravir [1], strong UGT1A1 inhibitors ---> SmPC of [1] of EMA

Co-administration of elvitegravir with medicinal products that are potent inhibitors of UGT1A1/3 may result in increased elvitegravir plasma concentrations and dose modifications may be required.

Elvitegravir [1], strong UGT1A3 inhibitors ---> SmPC of [1] of EMA

Co-administration of elvitegravir with medicinal products that are potent inhibitors of UGT1A1/3 may result in increased elvitegravir plasma concentrations and dose modifications may be required.

Elvitegravir [1], tenofovir ---> SmPC of [1] of EMA

No dose adjustment is required when elvitegravir is co-administered with tenofovir disoproxil fumarate.

Elvitegravir [1], tipranavir ---> SmPC of [1] of EMA

Due to insufficient clinical data, the combination of elvitegravir with tipranavir is not recommended

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

Elvitegravir, CYP2C9 inductor, may decrease the plasma levels of warfarin

Elvitegravir [1], zidovudine ---> SmPC of [1] of EMA

No dose adjustment is required when elvitegravir is co-administered with zidovudine.

Elvitegravir, elvitegravir [2] ---> SmPC of [2] of EMA

Elvitegravir should not be used in combination with products containing elvitegravir

Elvitegravir, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Medicinal products that inhibit OATP1B1/3 (e.g. elvitegravir, ciclosporin, darunavir, lopinavir) increase systemic concentrations of glecaprevir.

Elvitegravir, maraviroc [2] ---> SmPC of [2] of EMA

Elvitegravir per se is not expected to affect maraviroc exposure to a clinically relevant degree. Elvitegravir as a single agent is indicated only in combination with certain ritonavir boosted PIs.

Elvitegravir, strong CYP3A4 inhibitors

The strong CYP3A4 inhibition may increase plasma levels of elvitegravir

Elvitegravir/ritonavir, ketoconazole ---> SmPC of [elvitegravir] of EMA

No dose adjustment is required when elvitegravir is co-administered with ketoconazole. Due to inhibition of CYP3A by ritonavir, ketoconazole exposure is increased.

Elvitegravir/ritonavir, rifabutin ---> SmPC of [elvitegravir] of EMA

Co-administration of elvitegravir and rifabutin is not recommended.

           CONTRAINDICATIONS of Elvitegravir (Vitekta)

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

           Co-administration with the following medicinal products due to the potential for loss of virologic response and possible development of resistance:

           - anticonvulsants: carbamazepine, phenobarbital, phenytoin

           - antimycobacterials: rifampicin

           - herbal products: St. John’s wort (Hypericum perforatum)

https://www.ema.europa.eu/en/documents/product-information/vitekta-epar-product-information_en.pdf 29/05/2017 (withdrawn) 

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya)

Ability to drive, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Genvoya may have minor influence on the ability to drive and use machines. Patients should be informed that dizziness has been reported during treatment with Genvoya.

Adefovir dipivoxil, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Genvoya should not be administered concomitantly with medicinal products containing tenofovir disoproxil (as fumarate), lamivudine or adefovir dipivoxil used for the treatment of HBV infection.

Alfuzosin, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Amiodarone, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Amlodipine, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Concentrations of calcium channel blocker may be increased when co-administered with cobicistat.

Antacids, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Elvitegravir plasma concentrations are lower with antacids due to local complexation in the gastrointestinal tract and not to changes in gastric pH. It is recommended to separate Genvoya and antacid administration by at least 4 hours.

Antiretrovirals, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Genvoya should not be co-administered with other antiretroviral medicinal products. Therefore, information regarding drug-drug interactions with other antiretroviral products (including PIs and NNRTIs]) is not provided

Apixaban, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration with Genvoya may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk. Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Genvoya.

Atorvastatin, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Concentrations of atorvastatin are increased when co-administered with elvitegravir and cobicistat. Start with the lowest possible dose of atorvastatin with careful monitoring upon co-administration with Genvoya.

Benzodiazepines, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC 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.

Betablockers, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Concentrations of the beta-blocker may be increased when co-administered with cobicistat.

Betamethasone, 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.

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.

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.

Breast-feeding, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Therefore, Genvoya 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.

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.

Buprenorphine/naloxone, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

No dose adjustment of buprenorphine/naloxone is required.

Buspirone, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC 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.

Carbamazepine, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration of carbamazepine, a potent CYP3A inducer, may significantly decrease cobicistat plasma concentrations. Co-administration of Genvoya with carbamazepine is contraindicated

Cisapride, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Clarithromycin, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Patients with CrCl greater than or equal to 60 mL/min: No dose adjustment of clarithromycin is required. Patients with CrCl between 30 mL/min and 60 mL/min: The dose of clarithromycin should be reduced by 50%.

Clopidogrel, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration of clopidogrel with cobicistat is expected to decrease clopidogrel active metabolite plasma concentrations, which may reduce the antiplatelet activity of clopidogrel. Co-administration of Genvoya with clopidogrel is not recommended.

Clorazepate, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC 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.

Colchicine, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration with Genvoya may result in increased plasma concentrations of this medicinal product. Dose reductions of colchicine may be required.

Contraceptives, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Female patients of childbearing potential should use either a hormonal contraceptive containing at least 30 痢 ethinylestradiol and containing norgestimate as the progestagen or should use an alternative reliable method of contraception

Corticosteroids metabolized by CYP3A4, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC o

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.

Corticosteroids primarily metabolised by CYP3A [1], elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide --

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.

Cyclosporine, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Concentrations of this immunosuppressant agent may be increased when administered with cobicistat. Therapeutic monitoring is recommended upon co-administration with Genvoya.

Dabigatran, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration with Genvoya may increase dabigatran plasma concentrations with similar effects as seen with other strong P-gp inhibitors. Co-administration of Genvoya with dabigatran is contraindicated.

Diazepam, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC 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.

Digoxin, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

It is recommended that digoxin levels be monitored when digoxin is combined with Genvoya.

Dihydroergotamine, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Diltiazem, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Concentrations of calcium channel blocker may be increased when co-administered with cobicistat.

Disopyramide, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Concentrations of this antiarrhythmic drug may be increased when co-administered with cobicistat. Caution is warranted and clinical monitoring is recommended upon co-administration with Genvoya.

Drospirenone/ethinylestradiol, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of

Plasma concentrations of drospirenone may be increased when co-administered with cobicistat-containing products. Clinical monitoring is recommended due to the potential for hyperkalaemia.

Drugs primarily metabolised by CYP3A4, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC o

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Edoxaban, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA

Co-administration with Genvoya may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk. Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], erectile dysfunction ---> SmPC of [1] of EMA

For the treatment of erectile dysfunction, it is recommended that a single dose of sildenafil no more than 25 mg in 48 hours, vardenafil no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg in 72 hours be co-administered with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], ergometrine ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], ergotamine ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], escitalopram ---> SmPC of [1] of EMA

Concentrations of antidepressant agents may be increased when co-administered with cobicistat. Careful dose titration of the antidepressant and monitoring for antidepressant response is recommended.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], estazolam ---> SmPC of [1] 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.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], felodipine ---> SmPC of [1] of EMA

Concentrations of calcium channel blocker may be increased when co-administered with cobicistat.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], fertility ---> SmPC of [1] of EMA

There are no data on fertility from the use of Genvoya in humans. In animal studies there were no effects of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide on mating or fertility parameters (see section 5.3).

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], flecainide ---> SmPC of [1] of EMA

Concentrations of this antiarrhythmic drug may be increased when co-administered with cobicistat. Caution is warranted and clinical monitoring is recommended upon co-administration with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], fluconazole ---> SmPC of [1] of EMA

Concentrations of itraconazole, fluconazole and posaconazole may be increased when co-administered with cobicistat.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], flurazepam ---> SmPC of [1] 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.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], fluticasone ---> SmPC of [1] 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.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], fluvastatin ---> SmPC of [1] of EMA

Concentrations of these HMG Co-A reductase inhibitors are expected to transiently increase when administered with elvitegravir and cobicistat. Dose modifications are not necessary when administered in combination with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], foods ---> SmPC of [1] of EMA

Genvoya should be taken orally, once daily with food. The film-coated tablet should not be chewed, crushed, or split.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], itraconazol ---> SmPC of [1] of EMA

Concentrations of itraconazole, fluconazole and posaconazole may be increased when co-administered with cobicistat.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], ketoconazole ---> SmPC of [1] of EMA

Concentrations of ketoconazole and/or cobicistat may increase with co-administration of Genvoya. When administering with Genvoya, the maximum daily dose of ketoconazole should not exceed 200 mg per day.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], lamivudine ---> SmPC of [1] of EMA

Genvoya should not be administered concomitantly with medicinal products containing tenofovir disoproxil (as fumarate), lamivudine or adefovir dipivoxil used for the treatment of HBV infection.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], ledipasvir/sofosbuvir ---> SmPC of [1] of EMA

No dose adjustment of ledipasvir/sofosbuvir and Genvoya is warranted upon co-administration.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], lomitapide ---> SmPC of [1] of EMA

Lomitapide is highly dependent on CYP3A for its metabolism and coadministration with Genvoya may result in increased concentrations of lomitapide and potential for markedly increased transaminases. Coadministration with lomitapide is contraindicated

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], lorazepam ---> SmPC of [1] of EMA

Based on non-CYP-mediated elimination pathways for lorazepam, no effect on plasma concentrations is expected upon co-administration with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], lovastatine ---> SmPC of [1] of EMA

Co-administration of Genvoya and lovastatin and simvastatin is contraindicated (see section 4.3).

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], medicinal products that decrease renal function -

Medicinal products that decrease renal function may increase concentrations of emtricitabine.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], men ---> SmPC of [1] of EMA

The use of Genvoya should be accompanied by the use of effective contraception (see sections 4.4 and 4.5).

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], metformin ---> SmPC of [1] of EMA

Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with Genvoya. Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], methadone ---> SmPC of [1] of EMA

No dose adjustment of methadone is required.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], metoprolol ---> SmPC of [1] of EMA

Concentrations of the beta-blocker may be increased when co-administered with cobicistat.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], mexiletine ---> SmPC of [1] of EMA

Concentrations of this antiarrhythmic drug may be increased when co-administered with cobicistat. Caution is warranted and clinical monitoring is recommended upon co-administration with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], midazolam ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], mometasone ---> SmPC of [1] 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.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], multivitamin supplements ---> SmPC of [1] of EMA

As the effect of cationic complexation of elvitegravir cannot be excluded when Genvoya is co-administered with multivitamin supplements, it is recommended to separate Genvoya and multivitamin supplements dosing by at least 4 hours.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], nicardipine ---> SmPC of [1] of EMA

Concentrations of calcium channel blocker may be increased when co-administered with cobicistat.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], nifedipine ---> SmPC of [1] of EMA

Concentrations of calcium channel blocker may be increased when co-administered with cobicistat.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], nucleoside analogues ---> SmPC of [1] of EMA

Nucleoside and nucleotide analogues have been demonstrated to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], nucleotide analogues ---> SmPC of [1] of EMA

Nucleoside and nucleotide analogues have been demonstrated to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], oral contraceptives ---> SmPC of [1] of EMA

Caution should be exercised when co-administering Genvoya and a hormonal contraceptive. The hormonal contraceptive should contain at least 30 痢 ethinyloestradiol and contain drospirenone or norgestimate as the progestogen

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], PDE5 inhibitors ---> SmPC of [1] of EMA

PDE-5 inhibitors are primarily metabolised by CYP3A. Co-administration with Genvoya may result in increased plasma concentrations of sildenafil and tadalafil, which may result in PDE-5 inhibitor-associated adverse reactions.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], phenobarbital ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that induce CYP3A may result in significantly decreased cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], phenytoin ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that induce CYP3A may result in significantly decreased cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], pimozide ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], pitavastatin ---> SmPC of [1] of EMA

Concentrations of pitavastatin may be increased when administered with elvitegravir and cobicistat. Caution should be exercised when co-administering Genvoya with pitavastatin.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], posaconazole ---> SmPC of [1] of EMA

Concentrations of itraconazole, fluconazole and posaconazole may be increased when co-administered with cobicistat.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], prasugrel ---> SmPC of [1] of EMA

Genvoya is not expected to have a clinically relevant effect on plasma concentrations of the active metabolite of prasugrel. No dose adjustment of prasugrel is required.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], pravastatine ---> SmPC of [1] of EMA

Concentrations of these HMG Co-A reductase inhibitors are expected to transiently increase when administered with elvitegravir and cobicistat. Dose modifications are not necessary when administered in combination with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], prednisone ---> SmPC of [1] 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.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], pregnancy ---> SmPC of [1] of EMA

Therefore, therapy with Genvoya should not be initiated during pregnancy, and women who become pregnant during therapy with Genvoya should be switched to an alternative regimen (see section 4.4).

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], propafenone ---> SmPC of [1] of EMA

Concentrations of this antiarrhythmic drug may be increased when co-administered with cobicistat. Caution is warranted and clinical monitoring is recommended upon co-administration with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], quinidine ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], rifabutin ---> SmPC of [1] of EMA

Co-administration of rifabutin, a potent CYP3A inducer, may significantly decrease cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], rifampicin ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that induce CYP3A may result in significantly decreased cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], rivaroxaban ---> SmPC of [1] of EMA

Co-administration with Genvoya may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk. Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], rosuvastatin ---> SmPC of [1] of EMA

Concentrations of rosuvastatin are transiently increased when administered with elvitegravir and cobicistat. Dose modifications are not necessary when rosuvastatin is administered in combination with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], salmeterol ---> SmPC of [1] of EMA

Co-administration with Genvoya may result in increased plasma concentrations of salmeterol, which is associated with the potential for serious or life-threatening adverse reactions. Concurrent administration of salmeterol and Genvoya is not recommended.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], sertraline ---> SmPC of [1] of EMA

Concentrations of sertraline are not affected upon co-administration with Genvoya. No dose adjustment is required upon co-administration.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], sildenafil ---> SmPC of [1] of EMA

Co-administration of Genvoya and sildenafil for the treatment of pulmonary arterial hypertension is contraindicated.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], simvastatine ---> SmPC of [1] of EMA

Co-administration of Genvoya and lovastatin and simvastatin is contraindicated (see section 4.3).

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], sirolimus ---> SmPC of [1] of EMA

Concentrations of this immunosuppressant agent may be increased when administered with cobicistat. Therapeutic monitoring is recommended upon co-administration with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], St. John's wort ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that induce CYP3A may result in significantly decreased cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that induce CYP3A may result in significantly decreased cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], studies conducted with other medicinal products -

No clinically significant drug-drug interactions have been either observed or are expected between the components of Genvoya and the following medicinal products: entecavir, famciclovir, ribavirin, famotidine, and omeprazole.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], substrates of ---> SmPC of [1] of EMA

Cobicistat and tenofovir alafenamide are not inhibitors of human UGT1A1 in vitro. It is not known whether cobicistat, emtricitabine, or tenofovir alafenamide are inhibitors of other UGT enzymes.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], systemic lidocaine ---> SmPC of [1] of EMA

Concentrations of this antiarrhythmic drug may be increased when co-administered with cobicistat. Caution is warranted and clinical monitoring is recommended upon co-administration with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], tacrolimus ---> SmPC of [1] of EMA

Concentrations of this immunosuppressant agent may be increased when administered with cobicistat. Therapeutic monitoring is recommended upon co-administration with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], tadalafil ---> SmPC of [1] of EMA

Caution should be exercised, including consideration of dose reduction, when co-administering Genvoya with tadalafil for the treatment of pulmonary arterial hypertension.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], telaprevir ---> SmPC of [1] of EMA

Co-administration with telaprevir has the potential to adversely affect the intracellular activation and clinical antiviral efficacy of tenofovir alafenamide, therefore co-administration of Genvoya and telaprevir is not recommended.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], telithromycin ---> SmPC of [1] of EMA

Concentrations of telithromycin and/or cobicistat may be altered with co-administration of Genvoya. Clinical monitoring is recommended upon co-administration of Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], tenofovir disoproxil ---> SmPC of [1] of EMA

Genvoya should not be administered concomitantly with medicinal products containing tenofovir disoproxil (as fumarate), lamivudine or adefovir dipivoxil used for the treatment of HBV infection.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], timolol ---> SmPC of [1] of EMA

Concentrations of the beta-blocker may be increased when co-administered with cobicistat.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], trazodone ---> SmPC of [1] of EMA

Concentrations of antidepressant agents may be increased when co-administered with cobicistat. Careful dose titration of the antidepressant and monitoring for antidepressant response is recommended.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], triamcinolone ---> SmPC of [1] 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.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], triazolam ---> SmPC of [1] of EMA

Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], tricyclic antidepressant ---> SmPC of [1] of EMA

Concentrations of antidepressant agents may be increased when co-administered with cobicistat. Careful dose titration of the antidepressant and monitoring for antidepressant response is recommended.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], tubular secretion ---> SmPC of [1] of EMA

Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may increase concentrations of emtricitabine, and/or the co-administered medicinal product.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], verapamil ---> SmPC of [1] of EMA

Concentrations of calcium channel blocker may be increased when co-administered with cobicistat.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], voriconazole ---> SmPC of [1] of EMA

Concentrations of voriconazole may increase or decrease when co-administered with Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], warfarin ---> SmPC of [1] of EMA

Concentrations of warfarin may be affected upon co-administration with Genvoya. It is recommended that the international normalised ratio (INR) be monitored upon co-administration of Genvoya.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], women of childbearing potential ---> SmPC of [1]

The use of Genvoya should be accompanied by the use of effective contraception (see sections 4.4 and 4.5).

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], zolpidem ---> SmPC of [1] 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.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, sofosbuvir/velpatasvir [2] ---> SmPC of [2] of EMA

No dose adjustment of Epclusa or elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate is required.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, sofosbuvir/velpatasvir/voxilaprevir [2] ---> SmPC of

Inhibition of OATP1B, P-gp/BCRP and CYP3A. No dose adjustment of Vosevi or elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate is required.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, SSRI [2] ---> SmPC of [2] of EMA

Concentrations of antidepressant agents may be increased when co-administered with cobicistat. Careful dose titration of the antidepressant and monitoring for antidepressant response is recommended.

 CONTRAINDICATIONS of Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya)

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

            Co-administration with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious or life-threatening adverse reactions. Therefore, Genvoya should not be co-administered with medicinal products that include, but are not limited to, the following (see sections 4.4 and 4.5):