LEVULAN KERASTICK Rx
Generic Name and Formulations:
Aminolevulinic acid HCl 20%; topical soln; contains alcohol.
Sun Pharmaceutical Industries
Indications for LEVULAN KERASTICK:
In combination with blue light illumination (BLU-U Blue Light Photodynamic Therapy Illuminator), for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities.
Clean and dry affected area. Apply to lesions on either scalp, face, or upper extremities, but not simultaneously. One application and one dose of illumination per treatment site per 8-week treatment session. Face or scalp: illumination (second stage) must take place 14–18hrs after application. Protect treated lesions from sun with a head covering. Upper extremities: occlude treated lesions with low density polyethylene plastic wrap and net dressing; protect from sun with long-sleeved shirt and/or gloves. Illumination (second stage) must take place 3hrs after application. Delay in illumination: protect treated lesions for ≥40hrs; see full labeling. Treated lesions not completely resolved after 8 weeks may be treated a second time.
<18yrs: not established.
Cutaneous photosensitivity at wavelengths of 400–450nm. Porphyria or known allergies to porphyrins.
Avoid exposure of photosensitive treatment sites to sunlight or bright indoor light for ≥40hrs. Avoid applying to eyes, mucous membranes, perilesional skin (no more than 5mm around target lesions). Excessive irritation if applied under occlusion >3hrs. Inherited or acquired coagulation defects. Pregnancy. Nursing mothers.
Increased photosensitivity reaction with concomitant photosensitizing agents (eg, griseofulvin, thiazides, sulfonylureas, phenothiazines, sulfonamides, tetracyclines, St. John's wort).
Local reactions (eg, stinging/burning, erythema, edema, scaling/crusting, itching, erosion, hypo-/hyperpigmentation, oozing/vesiculation, dryness); photosensitivity.
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