Latisse
(Bimatoprost)Dosage & Administration
Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of
Do not reuse applicators and do not use any other brush/applicator to apply
Do not apply to the lower eyelash line
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.
There is the potential for hair growth to occur in areas where
Advise the patient to read the FDA-approved patient labeling .
Inform patients that
Additional applications of
Inform patients not to apply to the lower eyelash line. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material.
The onset of effect is gradual but is not significant in the majority of patients until 2 months. Counsel patients that the effect is not permanent and can be expected to gradually return to the original level upon discontinuation of treatment with
Instruct patients that the
In patients using
Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of
Advise patients about the potential for increased brown iris pigmentation which is likely to be permanent. Increased iris pigmentation has occurred when bimatoprost solution was administered.
Inform patients of the possibility of hair growth occurring outside of the target treatment area if
Advise patients that if they develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of
Advise patients that
Distributed by:
AbbVie Inc.
North Chicago, IL 60064
© 2024 AbbVie. All rights reserved.
LATISSE and its design are trademarks of Allergan, Inc., an AbbVie company.
v3.0USPI3616
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Additional applications of
Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level.
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Latisse Prescribing Information
Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of
Do not reuse applicators and do not use any other brush/applicator to apply
Do not apply to the lower eyelash line
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.
There is the potential for hair growth to occur in areas where
Advise the patient to read the FDA-approved patient labeling .
Inform patients that
Additional applications of
Inform patients not to apply to the lower eyelash line. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material.
The onset of effect is gradual but is not significant in the majority of patients until 2 months. Counsel patients that the effect is not permanent and can be expected to gradually return to the original level upon discontinuation of treatment with
Instruct patients that the
In patients using
Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of
Advise patients about the potential for increased brown iris pigmentation which is likely to be permanent. Increased iris pigmentation has occurred when bimatoprost solution was administered.
Inform patients of the possibility of hair growth occurring outside of the target treatment area if
Advise patients that if they develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of
Advise patients that
Distributed by:
AbbVie Inc.
North Chicago, IL 60064
© 2024 AbbVie. All rights reserved.
LATISSE and its design are trademarks of Allergan, Inc., an AbbVie company.
v3.0USPI3616
------Cut---Here---
Additional applications of
Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level.
Ophthalmic solution containing bimatoprost 0.3 mg/mL.
There are no adequate and well-controlled studies of
In embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (AUC). These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC.
In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC.
Because animal reproductive studies are not always predictive of human response
In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on AUC). No abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day.
In an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). The NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC).
In a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day. These effects were observed at exposures at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. The NOAEL for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC).
The following adverse reactions have been identified during postapproval use of
- 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. ()5.1Effects 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 usingLUMIGAN®or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use ofLATISSE®may interfere with the desired reduction in IOP. Patients using prostaglandin analogs includingLUMIGAN®for IOP reduction should only useLATISSE®after consulting with their physician and should be monitored for changes to their intraocular pressure. - Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent. (,5.2Iris 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
[seeAdverse 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.)5.3Lid PigmentationBimatoprost 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.