LEVULAN® KERASTICK® (aminolevulinic acid HCl) for topical solution, 20%, 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, or actinic keratosis of the upper extremities.
Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400–450 nm, porphyria, or known
allergies to porphyrins, and in patients with known sensitivity to any of the components of the LEVULAN KERASTICK
topical solution.
Application of LEVULAN KERASTICK topical solution should involve lesions on the face or scalp, or upper
extremities. Multiple lesions can be treated within a treatment region, but multiple treatment regions should not
be treated simultaneously.
Do not apply to the eyes or to mucus membranes. Irritation may be experienced if LEVULAN KERASTICK topical
solution is applied to eyes or mucous membranes. Treatment of upper extremities is approved after an incubation
time of 3 hours under occlusion. Excessive irritation may be experienced if this product is applied under
occlusion longer than 3 hours.
Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with
BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in
combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the
patient develops amnesia after treatment.
After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and
patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g.,
examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. To avoid
unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied by a qualified health
professional to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion.
Advise patients to wear a wide-brimmed hat or similar head covering of light-opaque material or a long-sleeved
shirt and/or gloves to shade the treated actinic keratoses from sunlight or other bright light sources until at
least 40 hours after the application of LEVULAN KERASTICK topical solution. Sunscreens will not protect against
photosensitivity reactions caused by visible light. The patient should be advised to reduce light exposure if the
sensations of stinging and/or burning are experienced.
LEVULAN KERASTICK topical solution has not been tested on patients with inherited or acquired coagulation defects.
It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin,
thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the
photosensitivity reaction of actinic keratoses treated with the LEVULAN KERASTICK topical solution.
During light treatment, both patients and medical personnel should be provided with blue blocking protective
eyewear as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions.
The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning,
scaling/crusting, itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling and dryness.
In clinical trials, severe stinging and/or burning was reported by at least 50% of face and scalp patients and 9%
of upper extremity patients at some time during treatment. However, less than 3% of subjects receiving treatment
for face or scalp lesions discontinued light treatment because of stinging/burning. No subjects discontinued light
treatment in the trial for upper extremity lesions.
Please refer to the
full Prescribing Information
for complete discussion of the risks associated with LEVULAN KERASTICK (aminolevulinic acid HCl) for topical
solution, 20%.
