Bimatoprost

Pharmacologic Category

Ophthalmic Agent, Antiglaucoma; Prostaglandin, Ophthalmic

Dosing: Adult

Elevated intraocular pressure:

Implant (Durysta): Intracameral: Insert 1 implant (10 mcg) in anterior chamber of affected eye. Limit to a single implant per eye; do not readminister to an eye that has received a prior implant.

Solution (Lumigan; Vistitan [Canadian product]): Ophthalmic, topical: Instill 1 drop into affected eye(s) once daily in the evening; do not exceed once-daily dosing (may decrease IOP-lowering effect). If used with other topical ophthalmic agents, separate administration by at least 5 minutes.

Hypotrichosis of the eyelashes (Latisse): Ophthalmic, topical: Place one drop on applicator and apply evenly along the skin of the upper eyelid at base of eyelashes once daily at bedtime; repeat procedure for second eye (use a clean applicator). Note: Onset of effect is gradual but is not significant in the majority of patients until 2 months.

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

Elevated intraocular pressure (Lumigan): Adolescents ≥16 years: Refer to adult dosing.

Hypotrichosis of the eyelashes (Latisse): Children ≥5 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Use: Labeled Indications

Elevated intraocular pressure (Durysta; Lumigan; Vistitan [Canadian product]): Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Hypotrichosis of the eyelashes (Latisse): Treatment of hypotrichosis of the eyelashes.

* See Uses in AHFS Essentials for additional information.

Class and Related Monographs

Ophthalmic Prostaglandin Analogues

Administration: Ophthalmic

Intracameral (Durysta): Insert implant under aseptic conditions. Use immediately after foil pouch is opened. Affected eye should not be dilated prior to procedure. Patient should remain upright for ≥1 hour after procedure. Refer to manufacturer's labeling for detailed administration instructions.

Latisse: Remove make-up and contact lenses prior to application; ensure face is clean. Apply with the sterile applicator provided only; do not use other brushes or applicators. Use a tissue or cloth to blot any excess solution on the outside of the upper eyelid margin; do not apply to lower eyelash line. Do not reuse applicators; use new applicator for second eye. Applying more than once nightly will not increase eyelash growth; eyelash growth is expected to return to baseline when therapy is discontinued. May reinsert contacts 15 minutes after application.

Lumigan; Vistitan [Canadian product]: May be used with other eye drops to lower intraocular pressure. If using more than one ophthalmic product, wait at least 5 minutes in between application of each medication. Remove contact lenses prior to administration and wait 15 minutes before reinserting.

Administration: Pediatric

Ophthalmic:

Latisse: Children ≥5 years and Adolescents: Remove make-up and contact lenses prior to application; ensure face is clean. Apply only with the sterile applicator provided; do not use other brushes or applicators. Use a tissue or cloth to blot any excess solution on the outside of the upper eyelid margin; do not apply to lower eyelash line. Do not reuse applicators; use new applicator for second eye. Applying more than once nightly will not increase eyelash growth; eyelash growth is expected to return to baseline when therapy is discontinued. May reinsert contacts 15 minutes after application.

Lumigan: Adolescents ≥16 years: May be used with other eye drops to lower intraocular pressure. If using more than one ophthalmic product, wait at least 5 minutes in between application of each medication. Remove contact lenses prior to administration and wait 15 minutes before reinserting.

Storage/Stability

Implant: Store between 2°C to 8°C (36°F to 46°F).

Solution: Store between 2°C to 25°C (36°F to 77°F).

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat glaucoma.

• It is used to lower high eye pressure.

• It is used to help eyelashes grow. It may take 2 months to see the full effect.

Frequently reported side effects of this drug

• Eyelid changes or eyelash changes

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Vision changes

• Eye pain

• Severe eye irritation

• Sensitivity to light

• Eye discharge

• Eye discoloration

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Contraindications

Hypersensitivity to bimatoprost or any component of the formulation.

Additional product-specific contraindications: Implant (Durysta): Active or suspected ocular or periocular infection; corneal endothelial cell dystrophy (eg, Fuchs dystrophy); prior corneal transplantation or endothelial cell transplant (eg, Descemet stripping automated endothelial keratoplasty); absent or ruptured posterior lens capsule (Note: Laser posterior capsulotomy in pseudophakic patients is not a contraindication if the intraocular lens fully covers the opening in the posterior capsule).

Warnings/Precautions

Concerns related to adverse effects:

• Bacterial keratitis: Inadvertent contamination of multiple-dose ophthalmic solutions has caused bacterial keratitis.

• Corneal effects: Intracameral implant may cause corneal adverse effects and increased risk of corneal endothelial cell loss; use with caution in patients with limited corneal endothelial cell reserve. Limit administration to a single implant per eye without retreatment.

• Endophthalmitis: Intraocular surgical procedures and injections are associated with endophthalmitis. Use proper aseptic injection technique and monitor patients appropriately.

• Macular edema: Macular edema, including cystoid macular edema, has been reported; use with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or patients with risk factors for macular edema.

• Ocular effects: May permanently change/increase brown pigmentation of the iris, the eyelid skin, periorbital tissue, and eyelashes; area(s) affected may vary based on bimatoprost formulation used. In addition, may increase the length, thickness, and/or number of eyelashes (may vary between eyes); changes occur slowly and may not be noticeable for months or years. Pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes may be reversible following discontinuation of therapy. Long-term consequences of increased pigmentation are not known.

• Ocular inflammation: Intraocular inflammation and exacerbation of inflammation may occur; use with caution in patients with active intraocular inflammation (eg, uveitis).

Disease-related concerns:

• Iridocorneal angle: Use intracameral implant with caution in patients with narrow iridocorneal angles (Shaffer grade <3) or anatomical obstruction (eg, scarring) that may prohibit the implant from settling in the inferior angle.

Special populations:

• Contact lens wearers: Topical solution formulations contain benzalkonium chloride which may be adsorbed and cause discoloration of soft contact lenses; remove contacts prior to administration and wait 15 minutes before reinserting.

Dosage form specific issues:

• Latisse: Patients receiving medications to reduce intraocular pressure should consult their healthcare provider prior to using; may interfere with desired reduction of intraocular pressure. Unintentional hair growth may occur on skin that has repeated contact with solution; apply to upper eyelid only, blot away excess.

• Lumigan: Safety and efficacy have not been determined for use in patients with angle-closure, inflammatory, or neovascular glaucoma.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

Evaluate the patient's or caregiver's ability to safely administer the correct dose of ophthalmic medication.

Pregnancy Considerations

According to the manufacturer, an increased risk of major birth defects or miscarriages has not been observed following use of bimatoprost ophthalmic drops in pregnant women.

Systemic absorption following ophthalmic use is limited. If ophthalmic drops are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988; Strelow 2020). Agents other than bimatoprost may be preferred for the treatment of glaucoma during pregnancy (Mathew 2019; Razeghinejad 2018; Strelow 2020).

Breast-Feeding Considerations

It is not known if bimatoprost is present in breast milk.

Systemic absorption following ophthalmic use is limited. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Briggs' Drugs in Pregnancy & Lactation

• Bimatoprost Ophthalmic

Adverse Reactions

Adverse reactions and percentages are for Lumigan unless noted:

>10%:

Dermatologic: Increased growth in number of eyelashes

Ophthalmic: Conjunctival hyperemia (25% to 45%; Latisse: <4%), eye pruritus (>10%; Latisse: <4%)

1% to 10%:

Central nervous system: Headache (1% to 5%), foreign body sensation of eye

Dermatologic: Erythema of eyelid (1% to 10%; Latisse: <4%), hyperpigmentation of eyelashes, local skin hyperpigmentation (Lumigan and Latisse)

Endocrine & metabolic: Hirsutism

Hepatic: Abnormal hepatic function tests (1% to 5%)

Infection: Infection (10% [primarily colds and upper respiratory tract infections])

Neuromuscular & skeletal: Asthenia (1% to 5%)

Ophthalmic: Dry eye syndrome (1% to 10%; Latisse: <4%), eye irritation (1% to 10%; Latisse: <4%), allergic conjunctivitis, asthenopia, blepharitis, burning sensation of eyes, cataract, conjunctival edema, conjunctival hemorrhage, eye discharge, eye pain, iris hyperpigmentation (may be delayed), lacrimation, photophobia, superficial punctate keratitis, visual disturbance

<1%, postmarketing, and/or case reports: Acute bronchospastic disease, bacterial keratitis (caused by inadvertent contamination of multiple-dose ophthalmic solutions), blurred vision, cystoid macular edema, deepening of the eyelid sulcus, dizziness, dyspnea, eyelid edema, hypertension, iritis, local dryness, local hypersensitivity reaction, macular edema, madarosis of eyebrow, nausea, skin rash (including macular and erythematous), trichorrhexis, uveitis

* See Cautions in AHFS Essentials for additional information.

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Latanoprost: The concomitant use of Latanoprost and Bimatoprost may result in increased intraocular pressure. Risk C: Monitor therapy

Latanoprostene Bunod: The concomitant use of Bimatoprost and Latanoprostene Bunod may result in increased intraocular pressure. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Monitoring Parameters

Intraocular pressure, ocular pigmentation changes.

Advanced Practitioners Physical Assessment/Monitoring

Monitor intraocular pressure. Educate patient on proper administration.

Nursing Physical Assessment/Monitoring

Instruct patient to report changes in eyesight. Educate patient on proper administration.

Product Availability

Durysta (bimatoprost intracameral implant): FDA approved March 2020; anticipated availability unknown. Consult the prescribing information for additional information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Implant, Intraocular:

Durysta: 10 mcg (1 ea) [contains polyethylene glycol]

Solution, External:

Latisse: 0.03% (3 mL, 5 mL) [contains benzalkonium chloride]

Generic: 0.03% (3 mL, 5 mL)

Solution, Ophthalmic:

Lumigan: 0.01% (2.5 mL, 5 mL, 7.5 mL) [contains benzalkonium chloride]

Generic: 0.03% (2.5 mL, 5 mL, 7.5 mL)

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, External:

Latisse: 0.03% (3 mL) [contains benzalkonium chloride]

Solution, Ophthalmic:

Lumigan: 0.03% (3 mL, 5 mL, 7.5 mL) [contains benzalkonium chloride]

Lumigan RC: 0.01% (2.5 mL, 3 mL, 5 mL, 7.5 mL) [contains benzalkonium chloride]

Vistitan: 0.03% (3 mL, 5 mL) [contains benzalkonium chloride]

Anatomic Therapeutic Chemical (ATC) Classification

• S01EE03

Generic Available (US)

May be product dependent

Pricing: US

Implant (Durysta Intraocular)

10 mcg (per each): $2,340.00

Solution (Bimatoprost External)

0.03% (per mL): $48.22

Solution (Bimatoprost Ophthalmic)

0.03% (per mL): $52.23 - $53.85

Solution (Latisse External)

0.03% (per mL): $51.43

Solution (Lumigan Ophthalmic)

0.01% (per mL): $99.23

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

As a synthetic analog of prostaglandin with ocular hypotensive activity, bimatoprost decreases intraocular pressure by increasing the outflow of aqueous humor. Bimatoprost may increase the percent and duration of hairs in the growth phase, resulting in eyelash growth.

Pharmacodynamics/Kinetics

Ophthalmic solution:

Note: Pharmacokinetic data based on topical solution formulation (unless otherwise noted).

Onset of action: Reduction of IOP: ~4 hours.

Peak effect: Maximum reduction of IOP: ~8 to 12 hours.

Distribution: Vd: 0.67 L/kg.

Protein binding: ~88%.

Metabolism: Undergoes oxidation, N-deethylation, and glucuronidation after reaching systemic circulation; forms metabolites.

Half-life elimination: IV: ~45 minutes.

Time to peak: ≤10 minutes.

Excretion: Urine (≤67%); feces (25%).

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Pharmacotherapy Pearls

The intraocular pressure-lowering effect was shown to be 7 to 8 mm Hg (topical solution) and 5 to 8 mm Hg (intracameral implant) in clinical studies.

FDA Approval Date

March 16, 2001

References

Durysta (bimatoprost) implant [prescribing information]. Madison, NJ: Allergan; March 2020.

Latisse (bimatoprost ophthalmic solution) [prescribing information]. Irvine, CA: Allergan; July 2017.

Latisse (bimatoprost ophthalmic solution) [product monograph]. Markham, Ontario, Canada: Allergan Inc; November 2018.

Lumigan (bimatoprost ophthalmic solution) [prescribing information]. Irvine, CA: Allergan; July 2017.

Mathew S, Harris A, Ridenour CM, et al. Management of glaucoma in pregnancy. J Glaucoma. 2019;28(10):937-944. doi:10.1097/IJG.0000000000001324[PubMed 31283700]

Razeghinejad MR. Glaucoma medications in pregnancy. Oman J Ophthalmol. 2018;11(3):195-199. doi:10.4103/ojo.OJO_212_2017[PubMed 30505107]

Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623.[PubMed 2903673]

Strelow B, Fleischman D. Glaucoma in pregnancy: an update. Curr Opin Ophthalmol. 2020;31(2):114-122. doi:10.1097/ICU.0000000000000641[PubMed 31922978]

Vistitan (bimatoprost ophthalmic solution) [product monograph]. Boucherville, Quebec, Canada: Sandoz Canada Inc; January 2019.

Brand Names: International

Bimagan (NL); Bimaprost (BD); Bimast (BD); Bimat (LK, VN); Bimato-Vision (AT); Bimatoswix (EG); Bimican (CZ); Careprost (LK); Glamigan (BR); Glash Vista (JP); Latisse (AR, BR, CL, HK, KR, KW, NZ, SG, UA); Lumigan (AE, AR, AT, AU, BB, BE, BG, BR, CH, CL, CN, CO, CR, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IL, IN, IS, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, VE, VN, ZA); Lumiprox (EG); Matrocond (EG); Sturiban (CZ); Vizibim (CZ)

Last Updated 5/20/20