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LEVULAN KERASTICK
Actinic keratoses
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Drug Name:

LEVULAN KERASTICK Rx

Generic Name and Formulations:
Aminolevulinic acid HCl 20%; topical soln; contains alcohol.

Company:
Sun Pharmaceutical Industries

Therapeutic Use:

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.

Adult:

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.

Children:

<18yrs: not established.

Contraindications:

Cutaneous photosensitivity at wavelengths of 400–450nm. Porphyria or known allergies to porphyrins.

Warnings/Precautions:

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.

Interactions:

Increased photosensitivity reaction with concomitant photosensitizing agents (eg, griseofulvin, thiazides, sulfonylureas, phenothiazines, sulfonamides, tetracyclines, St. John's wort).

Pharmacological Class:

Photosensitizer.

Adverse Reactions:

Local reactions (eg, stinging/burning, erythema, edema, scaling/crusting, itching, erosion, hypo-/hyperpigmentation, oozing/vesiculation, dryness); photosensitivity, transient amnestic episodes (monitor).

How Supplied:

Single-use applicators—6

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