Warnings/Precautions

Concerns related to adverse effects:

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

• Ocular effects: May permanently change/increase brown pigmentation of the iris, the eyelid skin, periorbital tissue, and eyelashes. 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:

• Ocular disease: Use with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or patients with risk factors for macular edema. Safety and efficacy of Lumigan have not been determined for use in patients with angle-closure-, inflammatory-, or neovascular glaucoma.

Special populations:

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

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%), skin hyperpigmentation (Latisse: <4%), hyperpigmentation of eyelashes, pigmentation of the periocular skin

Endocrine & metabolic: Hirsutism

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

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

Neuromuscular & skeletal: Weakness (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% (Limited to important or life-threatening): Hair breakage, hypersensitivity reaction, hypertension, iritis, macular edema, madarosis, skin rash.