warnings and cautions
5 WARNINGS AND PRECAUTIONS Concurrent administration of LATISSE ® and IOP-lowering prostaglandin analogs in ocular hypertensive patients may decrease the IOP-lowering effect. Patients using these products concomitantly should be closely monitored for changes to their intraocular pressure. ( 5.1 ) Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent. ( 5.2 , 5.3 ) 5.1 Effects on Intraocular Pressure Bimatoprost ophthalmic solution (LUMIGAN ® ) lowers intraocular pressure (IOP) when instilled directly to the eye in patients with elevated IOP. In clinical trials, in patients with or without elevated IOP, LATISSE ® lowered IOP, however, the magnitude of the reduction was not cause for clinical concern. In ocular hypertension studies with LUMIGAN ® , it has been shown that exposure of the eye to more than one dose of bimatoprost daily may decrease the intraocular pressure lowering effect. In patients using LUMIGAN ® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of LATISSE ® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN ® for IOP reduction should only use LATISSE ® after consulting with their physician and should be monitored for changes to their intraocular pressure (see PATIENT COUNSELING INFORMATION, 17 ). 5.2 Iris Pigmentation Increased iris pigmentation has occurred when the same formulation of bimatoprost ophthalmic solution ( LUMIGAN ® ) was instilled directly onto the eye. Although iridal pigmentation was not reported in clinical studies with LATISSE ® , 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 administration of bimatoprost ophthalmic solution 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. Treatment with LATISSE ® solution can be continued in patients who develop noticeably increased iris pigmentation. Patients who receive treatment with LATISSE ® should be informed of the possibility of increased pigmentation (see PATIENT COUNSELING INFORMATION, 17 ). 5.3 Lid Pigmentation Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients. 5.4 Hair Growth Outside the Treatment Area There is the potential for hair growth to occur in areas where LATISSE ® solution comes in repeated contact with the skin surface. It is important to apply LATISSE ® only to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators, and to carefully blot any excess LATISSE ® from the eyelid margin to avoid it running onto the cheek or other skin areas (see PATIENT COUNSELING INFORMATION, 17 ). 5.5 Intraocular Inflammation LATISSE ® solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. 5.6 Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution ( LUMIGAN ® ) for elevated IOP. LATISSE ® 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. 5.7 Contamination of LATISSE® or Applicators The LATISSE ® bottle must be kept intact during use. It is important to use LATISSE ® solution as instructed, by placing one drop on the single-use-per-eye applicator. The bottle tip should not be allowed to contact any other surface since it could become contaminated. The accompanying sterile applicators should only be used on one eye and then discarded since reuse of applicators increases the potential for contamination and infections. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products (see PATIENT COUNSELING INFORMATION, 17 ). 5.8 Use with Contact Lenses LATISSE ® contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration (see PATIENT COUNSELING INFORMATION, 17 ).