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The LEVULAN KERASTICK (aminolevulinic acid) for Topical Solution contains alcohol and is intended for topical use only. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion.
General: During the time period between the application of LEVULAN KERASTICK (aminolevulinic acid) Topical Solution and exposure to activating light from the BLU-U Blue Light Photodynamic Therapy Illuminator, the treatment site will become photosensitive. After LEVULAN KERASTICK (aminolevulinic acid) Topical Solution application, patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) during the period prior to blue light treatment. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Before exposure to sunlight, patients should, therefore, protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK (aminolevulinic acid) Topical Solution outside the treatment site to eye or surrounding skin.
Application of LEVULAN KERASTICK (aminolevulinic acid) Topical Solution to perilesional areas of photodamaged skin of the face or scalp may result in photosensitization. Upon exposure to activating light from the BLU-U Blue Light Photodynamic Therapy Illuminator, such photosensitized skin may produce a stinging and/or burning sensation and may become erythematous and/or edematous in a manner similar to that of actinic keratoses treated with LEVULAN PDT. Because of the potential for skin to become photosensitized, the LEVULANKERASTICK for Topical Solution should be used by a qualified health professional to apply drug only to actinic keratoses and not perilesional skin.
The LEVULAN KERASTICK (aminolevulinic acid) for Topical Solution has not been tested on patients with inherited or acquired coagulation defects.
Carcinogenesis, Mutagenesis, Impairment to Fertility: No carcinogenicity testing has been carried out usingALA. No evidence of mutagenic effects was seen in four studies conducted with ALA to evaluate this potential. In the Salmonella-Escherichia coli/mammalian microsome reverse mutation assay (Ames mutagenicity assay), no increases in the number of revertants were observed with any of the tester strains. In the Salmonella-Escherichia coli/mammalian microsome reverse mutation assay in the presence of solar light radiation (Ames mutagenicity assay with light), ALA did not cause an increase in the number of revertants per plate of any of the tester strains in the presence or absence of simulated solar light. In the L5178Y TK± mouse lymphoma forward mutation assay, ALA was evaluated as negative with and without metabolic activation under the study conditions. PpIX formation was not demonstrated in any of these in vitro studies. In the in vivo mouse micronucleus assay, ALA was considered negativeunder the study exposure conditions. In contrast, at least one report in the literature has noted genotoxic effects in cultured rat hepatocytes after ALA exposure with PpIX formation. Other studies have documented oxidative DNA damagein vivo and in vitro as a result of ALA exposure.
No assessment of effects of ALA HCl on fertility has been performed in laboratory animals. It is unknown what effects systemic exposure to ALA HCl might have on fertility or reproductive function.
Pregnancy Category C: Animal reproduction studies have not been conducted with ALA HCl. It is also not known whether LEVULAN KERASTICK (aminolevulinic acid) Topical Solution can cause fetal harm whenadministered to a pregnant woman or can affect reproductive capacity. LEVULAN KERASTICK (aminolevulinic acid) Topical Solution should be given to a pregnant woman only if clearly needed.
Nursing Mothers: The levels of ALA or its metabolites in the milk of subjects treated with LEVULAN KERASTICK (aminolevulinic acid) Topical Solution have not been measured. Because many drugs are excreted in human milk, caution should be exercised when LEVULAN KERASTICK (aminolevulinic acid) Topical Solution is administered to a nursing woman.
Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.
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