Medical Editor: John P. Cunha, DO, FACOEP
Levulan Kerastick (aminolevulinic acid HCl) is a photosensitizing agent used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the face and scalp. Treatment involves application of Levulan, followed 14 to 18 hours later by exposure to a special blue light that causes the treated skin cells to die and slough off. Serious side effects of Levulan Kerastick are unlikely. You may experience:
- swelling, or
- burning of the area treated with Levulan during the light treatment.
These side effects should improve at the end of the light treatment. Following treatment, you will experience temporary redness, swelling, and scaling of the lesions and surrounding skin. These side effects should completely resolve by 4 weeks after treatment.
Levulan Kerastick dose is determined by a physician and is administered in a medical setting. Levulan may interact with griseofulvin, oral diabetes medicines, phenothiazines, sulfa drugs, antibiotics, or diuretics (water pills). Tell your doctor all medications you use. During pregnancy, Levulan should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Levulan Kerastick (aminolevulinic acid HCl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Serious side effects are not likely to occur. Stop using aminolevulinic acid and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).
You may experience some tingling, stinging, prickling, or burning of the area treated with aminolevulinic acid during the special light treatment. These feelings of discomfort should improve at the end of the light treatment. Following treatment, you will experience some redness, swelling, and scaling of the lesions, and to some degree, the surrounding skin. These changes are temporary and should completely resolve by 4 weeks after treatment. If these side effects are excessive, talk to your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Levulan Kerastick (Aminolevulinic Acid)
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.
Read the entire FDA prescribing information for Levulan Kerastick (Aminolevulinic Acid)
© Levulan Kerastick Patient Information is supplied by Cerner Multum, Inc. and Levulan Kerastick Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.