Important Safety Information About 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. Please 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. DO NOT APPLY LATISSE® to the lower lid.
  • LATISSE® solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated.

Who should not use LATISSE®?

Do not use LATISSE® if you:

  • Are allergic to one of the ingredients in LATISSE®
  • Are under 18 or if you are pregnant, trying to become pregnant or breastfeeding

If you use/used prescription products for eye pressure problems, use LATISSE® under your doctor’s care.

What are the most common side effects of LATISSE®?

In clinical trials of LATISSE®, the most frequently reported side effects  were:

  • eye pruritus
  • conjunctival hyperemia (redness of the eye)
  • skin hyperpigmentation (darkening of the skin)
  • ocular irritation
  • dry eye symptoms
  • and erythema (redness) of the eyelid.

These adverse events occurred in less than 4% of participants.

Postmarketing Experience: The following reactions have been identified during postmarketing use of LATISSE® in clinical practice:

  • eye swelling
  • eyelid edema (swelling)
  • hypersensitivity (local allergic reactions)
  • increased tear production
  • madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively)
  • periorbital and lid changes associated with a deepening of the eyelid sulcus (fold where the eyelid meets the lower eyebrow)
  • rash (including macular and erythematous)
  • skin discoloration around the eye (periorbital)
  • and vision blurred.

What is the FDA-approved use of LATISSE®?

LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis (thinning of the eyelashes) of the eyelashes by increasing their growth, including length, thickness, and darkness.

When should I call my primary provider?

Call your primary provider right away 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
  • Start a medication 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 Rory-affiliated provider before using LATISSE®?

Tell your Rory-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
  • Are using any intraocular medications

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

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.

Please see the full Prescribing Information for complete safety information.