What Is Latisse Solution/ Drops Used For?

LATISSE^® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

LATISSE^® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see Adverse Reactions (6.2)].

The following adverse reactions are described elsewhere in the labeling:

• Effects on Intraocular Pressure [see Warnings and Precautions (5.1)]
  
• Iris Pigmentation [see Warnings and Precautions (5.2)]
  
• Lid Pigmentation [see Warnings and Precautions (5.3)]
  
• Hair Growth Outside the Treatment Area [see Warnings and Precautions (5.4)]
  
• Intraocular Inflammation [see Warnings and Precautions (5.5)]
  
• Macular Edema [see Warnings and Precautions (5.6)]
  
• Hypersensitivity [see Contraindications (4)]

• Concurrent administration of LATISSE® and intraocular pressure (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 IOP. (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. 5.2

Iris Pigmentation

Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent

[see

Adverse Reactions (6.2)

].

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. 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. 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 and cause discoloration of soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.

Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of LATISSE ^® (bimatoprost ophthalmic solution) 0.03% on the disposable sterile applicator supplied with the package and apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. The upper lid margin in the area of lash growth should feel lightly moist without runoff. Blot any excess solution runoff outside the upper eyelid margin with a tissue or other absorbent cloth. Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator.

Do not reuse applicators and do not use any other brush/applicator to apply LATISSE ^®.

Do not apply to the lower eyelash line [see Warnings and Precautions ( 5.3 , 5.4 ) and Patient Counseling Information (17) ].

Additional applications of LATISSE ^® will not increase the growth of eyelashes.

Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level.

Ophthalmic solution containing bimatoprost 0.3 mg/mL.