Durysta (bimatoprost)

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No formal drug interaction studies using bimatoprost have been performed. The manufacturer states that pharmacokinetic interactions are unlikely.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Bimatoprost is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Conjunctival hyperemia, growth of eyelashes, and ocular pruritus occurred in approximately 15-45% of patients who received bimatoprost 0.03% ophthalmic solution for reduction of IOP in clinical trials. Approximately 3% of patients discontinued therapy because of conjunctival hyperemia. Ocular dryness, visual disturbance, ocular burning, foreign body sensation, ocular pain, pigmentation of the periocular skin, blepharitis, cataract, superficial punctate keratitis, periorbital erythema, ocular irritation, and eyelash darkening have been reported in approximately 3-10% of patients who received bimatoprost 0.03% ophthalmic solution in clinical trials. Adverse ocular effects reported in approximately 1-3% of patients include ocular discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, increases in iris pigmentation, and conjunctival edema. Adverse systemic events reported in approximately 1-10% of patients include infection (primarily colds and upper respiratory tract infections), headache, abnormal liver function test results, asthenia, and hirsutism.

Conjunctival hyperemia was reported in 31% of patients who received bimatoprost 0.01% ophthalmic solution for reduction of IOP in clinical trials. Approximately 1.6% of patients discontinued therapy because of conjunctival hyperemia. Conjunctival edema, conjunctival hemorrhage, eye irritation, ocular pain, ocular pruritus, eyelid erythema, eyelid pruritus, growth of eyelashes, hypertrichosis, instillation site irritation, punctate keratitis, skin hyperpigmentation, blurred vision, and decreased visual acuity were reported in 1-4% of patients who received bimatoprost 0.01% ophthalmic solution.

The most common adverse reactions reported during clinical trials in patients receiving bimatoprost 0.03% ophthalmic solution applied to the skin of the upper eyelid margins to increase eyelash growth include ocular pruritus, conjunctival hyperemia, and skin hyperpigmentation, each reported in approximately 3-4% of patients. Ocular irritation, dry eye symptoms, periorbital erythema, foreign body sensation, abnormal hair growth, and iris hyperpigmentation also were reported.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Use of bimatoprost for the treatment of open-angle glaucoma or ocular hypertension in pediatric patients younger than 16 years of age is not recommended because of potential safety concerns related to increased pigmentation following long-term use. (See Pigmentation under Cautions: Warnings/Precautions.)

In a randomized, double-blind, vehicle-controlled study in 71 pediatric patients 5-17 years of age with hypotrichosis, topical application of bimatoprost 0.03% to the upper eyelid margins once daily for 16 weeks was associated with improvement in overall eyelash prominence, as measured by an increase of at least one grade on the 4-point Global Eyelash Assessment (GEA) scale from baseline to week 16, in 73% of adolescents with hypotrichosis not associated with a contributory medical condition and 85 or 44% of pediatric patients with hypotrichosis caused by chemotherapy or associated with alopecia areata, respectively; response rates for vehicle recipients with these respective conditions were 7, 100, and 33%. No new safety concerns were identified in this study.

In developmental studies in animals, bimatoprost exposure was compared with the human exposure following once-daily, bilateral, topical administration of bimatoprost 0.3% to the eyes (cornea or conjunctival sac). Abortion or early delivery was observed in mice and rats at exposure levels of at least 33 and 94 times human exposure but not at exposure levels of 2.6 and 47 times human exposure, respectively. Reduced gestation period, reduced fetal body weight, and increased fetal and pup mortality were observed in rats at exposures levels of at least 41 times human exposure. No adverse effects were observed in rat offspring at exposures estimated at 14 times human exposure.

There are no adequate and well-controlled studies using bimatoprost in pregnant women. Postmarketing experience has revealed no increase in the risk of major birth defects or spontaneous abortions. Bimatoprost should be used during pregnancy only if the potential benefits justify the possible risk to the fetus.

It is not known whether bimatoprost is distributed into human milk following topical application to the eye. Bimatoprost is distributed into milk in rats following IV administration at a dose equivalent to 324 times the recommended human ocular dose of bimatoprost 0.03%; animal data are lacking at clinically relevant doses. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for bimatoprost and any potential adverse effects of the drug on the breast-fed infant.

No overall differences in safety and efficacy have been observed between geriatric patients and younger adults.