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LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

LUMIGAN® 0.01% was approved by the U.S. Food and Drug Administration (FDA) in 2010 for the treatment of high eye pressure, also called intraocular pressure (IOP), in people with open-angle glaucoma or ocular hypertension.1,2

INDICATION

LUMIGAN® (bimatoprost ophthalmic solution) 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.2

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Pigmentation
Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered. After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known.

Iris color change may not be noticeable for several months to years.

Intraocular Inflammation
Prostaglandin analogs, including bimatoprost, have been reported to cause intraocular inflammation. In addition, because these products may exacerbate inflammation, caution should be used in patients with active intraocular inflammation (e.g., uveitis).

Macular Edema
Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. LUMIGAN® 0.01% should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Use with Contact Lenses
Contact lenses should be removed prior to instillation of LUMIGAN® 0.01% and may be reinserted 15 minutes following its administration.

ADVERSE REACTIONS

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.

USE IN SPECIFIC POPULATIONS

Pediatric Use
Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.

For more information about LUMIGAN® (bimatoprost ophthalmic solution) 0.01%, please refer to the full prescribing information and the product website at www.lumigan.com.

Please See Full LUMIGAN® Product Information (PDF) 
LUMIGAN® Web site 


APC60IO15



  1. 2010 LUMIGAN® (bimatoprost ophthalmic solution) 0.01% FDA Approval Letter
  2. 2014 LUMIGAN® (bimatoprost ophthalmic solution) 0.01% Prescribing Information