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 of actinic keratoses is the combination of photosensitization by application of the LEVULAN KERASTICK topical solution to the lesions and subsequent illumination with BLU-U Blue Light Photodynamic Therapy Illuminator.

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.

• LEVULAN KERASTICK photodynamic therapy is a two-stage process for administration by a health care provider.
• Apply the drug product to the target lesions.
• lluminate 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.
  
  

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.

• 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. To avoid unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion.
• Irritation may be experienced if this product is applied to eyes or mucous membranes. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.