LATISSE® (bimatoprost ophthalmic solution) 0.03%

LATISSE® (bimatoprost ophthalmic solution) 0.03%

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LATISSE® (bimatoprost ophthalmic solution) 0.03%

LATISSE® (bimatoprost ophthalmic solution) 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5-heptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4.

Contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride 0.05 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 – 7.8.

Indications and usage

LATISSE® is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

Mechanism of Action

Bimatoprost is a structural prostaglandin analog. Although the precise mechanism of action is unknown, the growth of eyelashes is believed to occur by increasing the percent of hairs in, and the duration of the anagen or growth phase.

Dosage and 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

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.

Contraindications

LATISSE® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients.

Warnings and precautions

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.

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.

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.

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.

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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.

Intraocular Inflammation: LATISSE® solution 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 (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.

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

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.

Use in specific populations

Pregnancy: There are no adequate and well-controlled studies of LATISSE® (bimatoprost ophthalmic solution) 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience.

Lactation: It is not known whether topical ocular treatment with LATISSE® 0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LATISSE® 0.03% and any potential adverse effects on the breastfed child from LATISSE® 0.03%.

Pediatric Use: Use of LATISSE® was evaluated in a sixteen-week double-masked, randomized, vehicle-controlled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who had hypotrichosis with no associated medical condition. No new safety issues were observed.

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