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In Phase 3 studies, no non-cutaneous adverse events were found to be consistently associated with LEVULAN KERASTICK (aminolevulinic acid) Topical Solution application followed by blue light exposure.
Photodynamic Therapy Response: The constellation of transient local symptoms of stinging and/or burning, itching, erythema and edema as a result of LEVULAN KERASTICK (aminolevulinic acid) Topical Solution plus BLUU treatment was observed in all clinical studies of LEVULAN KERASTICK (aminolevulinic acid) for Topical Solution Photodynamic Therapy for actinic keratoses treatment. Stinging and/or burning subsided between 1 minute and 24 hours after the BLU-U Blue Light Photodynamic Therapy Illuminator was turned off, and appeared qualitatively similar to that perceived by patients with erythropoietic protoporphyria upon exposure to sunlight. There was no clear drug dose or light dose dependent change in the incidence or severity of stinging and/or burning.
In two Phase 3 trials, the sensation of stinging and/or burning appeared to reach a plateau at 6 minutes into the treatment. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of the patients at some time during treatment. The majority of patients reported that all lesions treated exhibited at least slight stinging and/or burning. Less than 3% of patients discontinued light treatment due to stinging and/or burning.
The most common changes in lesion appearance after LEVULAN KERASTICK (aminolevulinic acid) Topical Solution Photodynamic Therapy were erythema and edema. In 99% of active treatment patients, some or all lesions were erythematous shortly after treatment, while in 79% of vehicle treatment patients, some or all lesions were erythematous. In 35% of active treatment patients, some or all lesions were edematous, while no vehicle-treated patients had edematous lesions. Both erythema and edema resolved to baseline or improved by 4 weeks after therapy. LEVULAN KERASTICK (aminolevulinic acid) Topical Solution application to photodamaged perilesional skin resulted in photosensitization of photodamaged skin and in a photodynamic response. (see PRECAUTIONS).
Other Localized Cutaneous Adverse Experiences: Table 5 depicts the incidence and severity of cutaneous adverse events, stratified by anatomic site treated.
TABLE 5- Post-PDT Cutaneous Adverse Events - ALA-018/ALA-019
|LEVULAN (n=139)||Vehicle (n=41)||LEVULAN (n=42)||Veh (n=21)|
|Degree of Severity||Mild/ Moderate||Severe||Mild/ Moderate||Severe||Mild/ Moderate||Severe||Mild /Moderate||Severe|
|Skin disorder NOS||5%||0%||0%||0%||12%||0%||5%||0%|
Adverse Experiences Reported by Body System: In the Phase 3 studies, 7 patients experienced a serious adverse event. All were deemed remotely or not related to treatment. No clinically significant patterns of clinical laboratory changes were observed for standard serum chemical or hematologic parameters in any of the controlled clinical trials.
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There have been no formal studies of the interaction of LEVULAN KERASTICK (aminolevulinic acid) 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 the LEVULAN KERASTICK (aminolevulinic acid) for Topical Solution.
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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