Aminolevulinic acid

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, scalp, or upper extremities. LEVULAN KERASTICK for topical solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for photodynamic therapy (treatment) of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratoses of the upper extremities.

Following the application of LEVULAN KERASTICK topical solution, photosensitization occurs through the metabolic conversion of aminolevulinic acid to protoporphyrin IX (PpIX), a photosensitizer, which accumulates in the skin. When exposed to light of appropriate wavelength and energy, the accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent upon the simultaneous presence of oxygen. The absorption of light results in an excited state of porphyrin molecules, and subsequent spin transfer from photoreactive porphyrins to molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals.

LEVULAN KERASTICK photodynamic therapy is a two-stage process for administration by a health care provider. Apply the drug product to the target lesions. Illuminate with blue light using the BLU-U ® Blue Light Photodynamic Therapy Illuminator after the incubation time of: 14 to 18 hours for scalp or face 3 hours for upper extremities, with occlusion LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved after 8 weeks. For topical use only. See full prescribing information for complete dosage and administration instruction. See BLU-U user manual for detailed lamp safety and operating instructions.

The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with: Cutaneous photosensitivity at wavelengths of 400-450 nm Porphyria or known allergies to porphyrins Known sensitivity to any of the components of the LEVULAN KERASTICK. Cutaneous photosensitivity at wavelengths of 400-450 nm. Porphyria or known allergies to porphyrins. Sensitivity to any of the components of the LEVULAN KERASTICK.

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. Avoid exposure of the photosensitive actinic keratoses to sunlight or bright indoor light prior to blue light treatment. Protect treated lesions from sunlight exposure. Sunscreens will not protect the patient against photosensitivity reactions. The LEVULAN KERASTICK for topical solution should be used by a qualified health professional.

The following adverse reactions are discussed in greater detail in the other sections of the labeling: Transient Amnestic Episodes Increased Photosensitivity Irritation Coagulation defects 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.

There have been no formal studies of the interaction of LEVULAN KERASTICK topical solution with any other drugs, and no drug-specific interactions were noted during any of the controlled clinical trials. It is, however, 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 LEVULAN KERASTICK topical solution. 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.

Storage Store between 20° - 25 °C (68° - 77 °F), excursions permitted to 15°- 30 °C (59° - 86 °F).