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
INFORMATION).
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 INFORMATION).
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.
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 INFORMATION).
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 (see PATIENT INFORMATION)
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 INFORMATION)
Patient Counseling Information
Nightly Application
Patients should be informed that LATISSE™ (bimatoprost ophthalmic
solution) should be applied every night using only the accompanying sterile
applicators. They should start by ensuring their face is clean, all makeup is
removed, and their contact lenses removed (if applicable). Then carefully place
one drop of LATISSE™ solution on the disposable sterile applicator
and brush cautiously along the skin of the upper eyelid margin at the base of
the eyelashes. If any LATISSE™ solution gets into the eye proper,
it will not cause harm. The eye should not be rinsed.
Additional applications of LATISSE™ will not increase the growth of eyelashes.
Patients should be informed 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. Patients should be counseled that the effect is not permanent and can be expected to gradually return to the original level upon discontinuation of treatment with LATISSE™ .
Handling the Bottle and Applicator
Patients should be instructed that the LATISSE™ bottle must be
maintained intact and to avoid allowing the tip of the bottle or applicator
to contact surrounding structures, fingers, or any other unintended surface
in order to avoid contamination of the bottle or applicator by common bacteria
known to cause ocular infections. Patients should also be instructed to only
use the applicator supplied with the product once and then discard since reuse
could result in using a contaminated applicator. Serious infections may result
from using contaminated solutions or applicators.
Potential for Intraocular Pressure Effects
LATISSE™ may lower intraocular pressure although not to a level
that will cause clinical harm.
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 for IOP reduction should only use LATISSE™ after consulting with
their physician.
Potential for Eyelid Skin Darkening
Patients should be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of LATISSE™ .
Potential for Iris Darkening
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. Increased iris pigmentation has occurred when
the same formulation of bimatoprost ophthalmic solution (LUMIGAN®)
was instilled directly onto the eye
Potential for Unexpected Hair Growth or Eyelash Changes
Patients should be informed of the possibility of hair growth occurring outside of the target treatment area if LATISSE™ repeatedly touches the same area of skin outside the treatment area. They should also be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are likely reversible upon discontinuation of treatment.
When to Seek Physician Advice
Patients should be advised 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 LATISSE™ . Patients on IOP-lowering medications
should not use LATISSE™ without prior consultation with their physician.
Use with Contact Lenses
Patients should be advised that LATISSE™ solution contains benzalkonium
chloride, which may be absorbed by soft contact lenses. Contact lenses should
be removed prior to application of LATISSE™ and may be reinserted
15 minutes following its administration.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (approximately 192 and 291 times the recommended human exposure based on blood AUC levels after topical corneal and/or conjunctival sac administration respectively) for 104 weeks.
Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse
lymphoma test, or in the in vivo mouse micronucleus tests.
Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day.
Use In Specific Populations
Pregnancy
Pregnancy Category C
Teratogenic effects: In embryo/fetal developmental studies in
pregnant mice and rats, abortion was observed at oral doses of bimatoprost which
achieved at least 33 or 97 times, respectively, the maximum intended human exposure
(based on blood AUC levels after topical ophthalmic administration to the cornea
or conjunctival sac).
At doses at least 41 times the maximum intended human exposure, the gestation length was reduced in the dams, the incidence of dead fetuses, late resorptions, peri- and postnatal pup mortality was increased, and pup body weights were reduced.
There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. Because animal reproductive studies are not always predictive of human response, LATISSE™ should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether LATISSE™ solution is excreted in human milk, although in animal studies, bimatoprost has been shown to be excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when LATISSE™ is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
Last updated on RxList: 2/23/2009