Actinic Keratoses

Levulan® Kerastick®

(aminolevulinic acid HCl) for Topical Solution, 20%

Before & After

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    Baseline

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    8 Weeks

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    12 Weeks

 

 

Important Risk Information

What is Levulan Kerastick used for?
The Levulan Kerastick for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp.

Who should NOT take Levulan?
Levulan Kerastick should not be taken by patients who have cutaneous photosensitivity at wavelengths at 400-450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the Levulan Kerastick for Topical Solution.

Levulan Kerastick has not been tested on patients with inherited or acquired coagulation defects. There have been no formal studies of the interaction of Levulan Kerastick for Topical Solution with any other drugs and no drug-specific interactions were noted during any of the controlled clinical trials. It is possible that concomitant use of other known photosensitizing agents might increase the photosensitivity reaction of actinic keratoses treated with the Levulan Kerastick. It is important to tell your physician if you are taking any oral medications or using any topical prescription or non-prescription products on your face or scalp. Tell your doctor if you are pregnant or nursing.

What are the possible side effects?
The most common side effects include scaling/crusting, hypo/hyper-pigmentation, itching, stinging, and/or burning, erythema and edema. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of patients at some time during the treatment.

What precautions should be taken?
Patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light for at least 40 hours after application of Levulan Kerastick. Exposure may result in a stinging and/or burning sensation and may cause erythema or edema of the lesions. Sunscreens will not protect against photosensitivity reactions caused by visible light.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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