Safety Information
Warnings and Precautions: In patients using LUMIGAN®
(bimatoprost ophthalmic solution) 0.03% or other prostaglandin analogs for the treatment
of elevated intraocular pressure (IOP), 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.
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.
Bimatoprost has been reported to cause pigment changes (darkening) to periorbital
pigmented tissues and eyelashes.
There is the potential for hair growth to occur in areas where LATISSE®
solution comes in repeated contact with skin surfaces. Apply LATISSE®
only to the skin of the upper eyelid margin at the base of the eyelashes.
LATISSE® solution should be used with caution in
patients with active intraocular inflammation (eg, uveitis) because the inflammation
may be exacerbated.
Macular edema, including cystoid macular edema, has been reported during treatment
with bimatoprost ophthalmic solution (LUMIGAN®)
for elevated intraocular pressure (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.
There have been reports of bacterial keratitis associated with the use of multiple-dose
containers of topical ophthalmic products.
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.
Adverse Reactions: The most frequently reported adverse events
were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation,
dry eye symptoms, and erythema of the eyelid. These events occurred in less than
4% of patients.
Patients 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.
|
Most frequently reported adverse events1,2
|
Number of patients (%)
|
|
|
LATISSE® (n = 137)
|
Vehicle (n = 141)
|
|
Eye pruritus (eye itching)
|
5 (3.6)
|
1 (0.7)
|
|
Conjunctival hyperemia (eye redness)
|
5 (3.6)
|
0 (0.0)
|
|
Skin hyperpigmentation (skin darkening)
|
4 (2.9)
|
1 (0.7)
|
|
Ocular irritation
|
3 (2.2)
|
2 (1.4)
|
|
Dry eye
|
3 (2.2)
|
1 (0.7)
|
|
Erythema (redness) of eyelid
|
3 (2.2)
|
1 (0.7)
|
Clinical trial results from a multicenter, randomized, double-masked, parallel study.
Fewer than 4% of patients experienced treatment-related adverse events1,2
Postmarketing Experience: The following reactions have been identified
during postmarketing use of LATISSE® in clinical
practice: burning sensation (eyelid), erythema periorbital, eye swelling, eyelid
irritation, eyelid edema, eyelid pruritus, iris hyperpigmentation, lacrimation increased,
madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections
of eyelashes, and temporary eyelash breakage, respectively), rash (including macular,
erythematous, and pruritic limited to the eyelids and periorbital region), skin
discoloration (periorbital), and vision blurred.
Use in Specific Populations: Use in pediatric patients below the
age of 16 years is not recommended because of potential safety concerns related
to increased pigmentation following long-term chronic use.
For additional safety information, please see full Prescribing Information.
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