Bimatoprost Ophthalmic Solution 0.03% for Glaucoma

The following adverse reactions are described elsewhere in the labeling:

• Pigmentation including blepharal pigmentation and iris hyperpigmentation [see WARNINGS AND PRECAUTIONS]
• Eyelash Changes [see WARNINGS AND PRECAUTIONS]
• Intraocular Inflammation [see WARNINGS AND PRECAUTIONS]
• Macular Edema [see WARNINGS AND PRECAUTIONS]
• Hypersensitivity [see CONTRAINDICATIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% of patients discontinued therapy due to conjunctival hyperemia. Other adverse drug reactions (reported in 1 to 4% of patients) with LUMIGAN® 0.01% in this study included conjunctival edema, conjunctival hemorrhage, eye irritation, eye pain, eye pruritus, erythema of eyelid, eyelids pruritus, growth of eyelashes, hypertrichosis, instillation site irritation, punctate keratitis, skin hyperpigmentation, vision blurred, and visual acuity reduced.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of LUMIGAN® 0.01%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to LUMIGAN®, or a combination of these factors include: asthma-like symptoms, dry eye, dyspnea, eye discharge, eye edema, foreign body sensation, headache, hypersensitivity including signs and symptoms of eye allergy and allergic dermatitis, lacrimation increased, and periorbital and lid changes including deepening of the eyelid sulcus.

Potential For Pigmentation

Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Also inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of LUMIGAN®(bimatoprost ophthalmic solution) 0.01%.

Potential For Eyelash Changes

Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with LUMIGAN® 0.01%. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.

Handling The Container

Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

When To Seek Physician Advice

Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of LUMIGAN® 0.01%.

Use With Contact Lenses

Advise patients that LUMIGAN® 0.01% contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of LUMIGAN® 0.01% and may be reinserted 15 minutes following its administration.

Use With Other Ophthalmic Drugs

Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications.

• Glaucoma
• LASIK Eye Surgery
• Tonometry
• Visual Field Test