Lumigan 0.01% Special Precautions

Pigmentation: Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues. When LUMIGAN 0.03% (multidose) was instilled directly into the eye (for treatment of elevated IOP), the most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Periorbital tissue pigmentation has been reported to be reversible in some patients. Patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long term effects of increased pigmentation are not known. Iris color changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with LUMIGAN 0.01% (bimatoprost ophthalmic solution) can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. (See Potential for Pigmentation under Patient Counselling Information.)
Eyelash Changes/Potential hair growth: LUMIGAN 0.01% may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.
There is the potential for hair growth to occur in areas where LUMIGAN 0.01% solution comes repeatedly in contact with the skin surface. Thus, it is important to apply LUMIGAN 0.01% as instructed and to avoid it running onto the cheek or other skin areas.
Before treatment is initiated, patients should be informed of the possibility of eyelash growth since this has been observed during treatment with prostaglandin analogues, including LUMIGAN.
Intraocular Inflammation: LUMIGAN 0.01% should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Macular Edema: Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution for elevated IOP.
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 edema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).
Angle-closure, Inflammatory or Neovascular Glaucoma: LUMIGAN 0.01% has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent ocular disease. Patients with a disruption of the ocular epithelial surface are at greater risk of developing bacterial keratitis.
Patient should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of the solution. (See Handling the Container under Patient Counselling Information.)
Use with Contact Lenses: LUMIGAN 0.01% contains the preservative benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses prior to administration of LUMIGAN 0.01% and wait at least 15 minutes following administration before reinserting soft contact lenses.
Use with Prostaglandin Analogs: In LUMIGAN 0.03% studies in patients with glaucoma or ocular hypertension, it has been shown that more frequent exposure of the eye to more than one dose of bimatoprost daily may decrease the IOP-lowering effect. Patients using LUMIGAN with other prostaglandin analogs should be monitored for changes to their intraocular pressure.
Hepatic Impairment: LUMIGAN 0.01% has not been studies in patients with moderate to severe hepatic impairment and should therefore be used with caution in such patients. In patients with a history of mild liver disease or abnormal ALT, AST and/or bilirubin at baseline, bimatoprost 0.03% had no adverse effect on liver function over 48 months.
LUMIGAN has not been studied in patients with compromised respiratory function and should therefore be used with caution in such patients. In clinical studies, in those patients with a history of a compromised respiratory function, no significant untoward respiratory effects were seen.
Renal Impairment: There are no data specific for this patient population and the product should therefore be used with caution in such patients.
Effects on Ability to Drive and Operate Machine: As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.
Use in Children: Use in pediatric patients has not been evaluated and therefore use is not recommended in children or adolescents.
Use in the Elderly: No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.