LUMIGAN (bimatoprost)

There are 0 contraindications.

Drug contraindication overview.

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

Adverse reaction overview.

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.

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.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None