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LATISSE (BIMATOPROST) OPHTHALMIC SOLUTION 0.03%: 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 (Bimatoprost) 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 (Bimatoprost) ophthalmic solution.

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 (Bimatoprost) eye drops 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 (Bimatoprost) ophthalmic solution) 0.03% 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 (Bimatoprost) eye drops 0.03%, 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 Bimatoprost (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 Bimatoprost (Latisse) ophthalmic 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.

FDA-Approved Patient Package Insert

This will be laid out so this can be removed and provided to the Patient.

Manufactured and distributed by Allergan pharmaceutical company and its divisions.

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