Blue U Treatment for Actinic Keratosis
Now’s the time to manage your damage®
Levulan® Kerastick® (aminolevulinic acid HCl) for Topical Solution, 20% (LEVULAN KERASTICK) plus blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LEVULAN KERASTICK and BLUU PDT) is indicated for the treatment of minimally to moderately thick actinic keratosis of the face or scalp. Actinic keratoses (AKs) are roughtextured, dry, scaly patches on the skin that can lead to skin cancer. It is important to treat AKs because there is no way to tell when or which lesions will progress to squamous cell carcinoma (SCC), the second most common form of skin cancer. So, now’s the time to manage your damage! LEVULAN KERASTICK and BLU-U PDT, a 2-part treatment, is unique because it uses a light activated drug therapy to destroy AKs. How does it work? LEVULAN KERASTICK Topical Solution is applied to the AK. The solution is then absorbed by the AK cells where it is converted to a chemical that makes the cells extremely sensitive to light. When the AK cells are exposed to the BLU-U Blue Light Illuminator, a reaction occurs
which destroys the AK cells. The 2-part treatment offers the following conveniences:
• No prescription to fill
• No daily medication to remember
• Treatment is administered by a qualified healthcare professional
LEVULAN KERASTICK and BLU-U PDT can also fit your lifestyle:
• The 2-part, 2 office visit treatment is completed in less than 24 hours
• Low downtime*
• High ratings for cosmetic response1
• No scarring reported to date
*Patients treated with LEVULAN KERASTICK and BLU-U PDT should
avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. Ask your dermatologist if LEVULAN KERASTICK and BLU-U PDT is
right for you! 1Data on file; DUSA Pharmaceuticals, Inc.®
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 KERASTICK?
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 drugspecific 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.