Levulan® Kerastick® (aminolevulinic acid HCl) for Topical Solution, 20%
Initial U.S. Approval: 1999
-------------------------INDICATIONS AND USAGE-----------------------------
The LEVULAN KERASTICK for Topical Solution, a porphyrin precursor, 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 (1).
---------------------DOSAGE AND ADMINISTRATION ----------------------
Photodynamic therapy for actinic keratoses with LEVULAN KERASTICK for Topical Solution is a two stage process involving a) application of the product to the target lesions with LEVULAN KERASTICK Topical Solution, followed 14 to 18 hours later by b) illumination with blue light using the BLU-U® Blue Light Photodynamic Therapy Illuminator. Treated lesions that have not completely resolved after 8 weeks may be treated a second time with LEVULAN KERASTICK for Topical Solution Photodynamic Therapy (2).
--------------------DOSAGE FORMS AND STRENGTHS ---------------------
Solution containing 20% aminolevulinic acid hydrochloride (ALA HCl) by weight in a plastic applicator device (3).
------------------------------CONTRAINDICATIONS----------------------------
Cutaneous photosensitivity at wavelengths of 400-450 nm (4).
----------------------WARNINGS AND PRECAUTIONS ------------------
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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 (5.1).
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The LEVULAN KERASTICK for Topical Solution should be used by a qualified health professional to apply drug only to actinic keratoses and not perilesional skin (5.2).
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Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion (5.2).
-----------------------------ADVERSE REACTIONS ------------------------------
Adverse reactions occurring during clinical trials with an incidence ≥ 2% were erythema, edema, stinging/burning, scaling/crusting, hypo/hyperpigmentation, itching/pruritus, erosion, wheal/flare, vesiculation, ulceration, bleeding/hemorrhage, pain, pustules, tenderness, scabbing and dysesthesia (6).
To report SUSPECTED ADVERSE REACTIONS, contact DUSA Pharmaceuticals, Inc. at (877) 533-3872 or FDA at (800) FDA-1088 or www.fda.gov/medwatch
-----------------------------DRUG INTERACTIONS ------------------------------
There have been no formal studies of the interaction of LEVULAN KERASTICK for 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 griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with LEVULAN KERASTICK Topical Solution (7).
See 17 for PATIENT COUNSELING INFORMATION
Revised: 03/2010
Full Prescribing Information: Contents*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Photosensitivity
5.2 Irritation
5.3 Coagulation Defects
6 ADVERSE REACTIONS
7. DRUG INTERACTIONS
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
10.1 LEVULAN KERASTICK Overdose
10.2 BLU-U Light Overdose
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Product Package – NDC Number
16.3 Storage
17 PATIE
