Important Safety Information for Latisse
What are the most important things I need to know about LATISSE®?
In patients using LUMIGAN® (bimatoprost ophthalmic solution) 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 (brown darkening of the colored part of the eye) has occurred when bimatoprost solution was administered directly into the eye. Please apply Latisse as directed (i.e. with the applicator at the base of the eyelids and NOT directly into the eye) so less medication makes its way into your eye. Be advised of the potential for increased brown iris pigmentation, which is likely to be permanent.
Bimatoprost has been reported to cause pigment changes (darkening) to the tissues around the eyes 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 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 and blot away any excess liquid with a clean tissue. DO NOT APPLY Latisse to the lower lid.
Latisse solution should be used with caution in patients with active intraocular inflammation (eg, uveitis). Patients with eye inflammation should not use Latisse without prior consultation with their eye physician.
Macular edema has been reported during the treatment of patients with glaucoma with Lumigan (which has the same active ingredient as Latisse). Latisse should be used with caution in patients who have had eye surgery on their eye lens or in patients with a torn posterior lens capsule. Providers affiliated with the Ro Derm platform do not prescribe Latisse via telemedicine to a patient who has had trauma to their lens or surgery on the lens.
The bottle tip of Latisse 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.
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.
Who should not use LATISSE®?
Do not use Latisse if you are allergic to Latisse or one of its ingredients. Patients on eye pressure-lowering medications should not use Latisse without prior consultation with their eye physician. It is our policy at Ro Derm not to prescribe Latisse to patients under 18 years old and to a person who is breastfeeding, pregnant, possibly pregnant, or trying to become pregnant.
What are the most common side effects of Latisse?
Common side effects include itchy and red eyes, which occured in about 4% of patients in the Latisse clinical trial. Other less common side effects usually occur on the skin close to where Latisse is applied, or in the eyes. They include skin darkening, which may be reversible, eye irritation, dryness of the eyes, and redness of the eyelids. Some patients also had photophobia, an increased eye sensitivity to the sun. For a comprehensive list of other potential side effects see the Warnings and Precautions section below or the Prescribing Information.
What is the FDA-approved use of Latisse?
Latisse (bimatoprost ophthalmic solution) 0.03% is a treatment to grow eyelashes for people with little or sparse growth of the eyelashes (hypotrichosis). It is clinically proven to make eyelashes longer, thicker, and darker.
When should I call my provider?
You are welcome to contact your provider at any time during your Latisse journey and you should seek your provider’s advice if you:
Experience a new eye condition (trauma or infection or injury)
Experience a sudden change/decrease in vision
Have eye surgery
Develop any eye reactions, especially eye redness and eyelid reactions
Develop any new symptom while on Latisse
Receive a diagnosis of high pressure in your eye or start treatment to lower the pressure in your eye. Patients on eye pressure-lowering medications should not use Latisse without prior consultation with their eye physician.
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
What should I tell my Ro Derm-affiliated provider before using Latisse?
Tell your Ro Derm-affiliated provider all of the medications you are currently taking, if you are pregnant, planning to become pregnant, or breastfeeding, or if you have a history of:
Glaucoma or increased intraocular pressure
Have or have a history of macular edema
Have or have a history of intraocular inflammation
Have any other condition affecting your eyes
Have recently had a procedure on one or both eyes, including Lasik surgery or cataract surgery
Are using any intraocular medications
Any changes to your eye health
If you are noticing a loss of eyelash hair, along with eyebrow, scalp or body hair, your provider should know because you could have a medical cause for the loss of eyelashes. Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm. You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.