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 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.