Pronunciation: METH-il a-MEE-noe-LEV-ue-LIN-ate
- Cream 16.8%
Photosensitization following application of methyl aminolevulinate cream occurs through the metabolic conversion of methyl aminolevulinate (prodrug) to photoactive porphyrins. The accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent upon the simultaneous presence of oxygen.
Indications and Usage
For the treatment of thin and moderately thick nonhyperkeratotic, nonpigmented actinic keratoses of the face and scalp in immunocompetent patients in combination with red-light illumination ( Aktilite CL128 lamp).
Cutaneous photosensitivity; known allergies to porphyrins; in patients with known sensitivities to any components of the cream, including peanut and almond oil.
Dosage and AdministrationNonhyperkeratotic, Nonpigmented Actinic Keratoses
Topical Apply a layer of cream about 1 mm thick to the lesion and the surrounding 5 mm of healthy skin using a spatula. A max dose of no more than 1 g (½ tube) topically per treatment session may be used. Cover area with an occlusive, nonabsorbent dressing for 3 h. Follow application by photoactivation via red-light illumination 3 h later. Two treatment sessions 7 days apart should be conducted. Lesion response should be assessed 3 mo after the last treatment session.
- Not for intravaginal, ophthalmic, or oral use.
- Wear nitrile gloves when applying and removing the cream.
- Before applying cream, the surface of the lesions should be debrided to remove scales and crusts and to roughen the surface of the lesion.
- Appropriate eye protection should be worn during illumination.
- Use of cream without subsequent red-light illumination is not recommended.
- After cream application, exposure of the photosensitive treatment sites to sunlight or bright indoor light should be avoided.
Store refrigerated at 36° to 46°F. Use contents within 1 wk of opening. Do not use after 24 h out of refrigerator.
None well documented.
Contact sensitization (52%); allergic reactions, including allergic contact dermatitis, eczema, erythema, swelling, and urticaria (postmarketing).
Skin burning/pain/discomfort (86%); erythema (63%); scabbing/crusting/blister/erosions (29%); pruritus (22%); skin or eyelid edema (18%); skin exfoliation (14%); skin warm (4%); application-site discharge, skin hemorrhage, skin tightness, skin hyperpigmentation (2%); skin pustules (postmarketing).
Eye disorders, including edema, eyelid swelling, keratitis, macular edema, and vitreous detachment (postmarketing).
Squamous cell carcinoma of the skin (postmarketing).
Monitor for lesion response at 3 mo posttherapy. Monitor for signs and symptoms of local skin reaction (eg, crusting, edema, erythema, pain, severe burning).
Category C .
Safety and efficacy not established.
Greater sensitivity of some older individuals cannot be ruled out.
A high rate of contact sensitization has been demonstrated. Cream is formulated with peanut and almond oil.
During the time period between the application of cream and exposure to red-light illumination, the treatment site will become photosensitive.
Not tested on patients with inherited or acquired coagulation defects.
Lesion recurrence rate
Recurrence rate of treated lesions is unknown.
Squamous cell carcinoma
Has been reported at sites distant from the application site.
None well documented.
- Advise patient that methyl aminolevulinate is highly allergenic. Advise patients sensitive to almond oil, peanut oil, and porphyins not to use this medication.
- Inform patients that this medication is to be applied in the health care provider's office and not by the patient.
- Advise patients to avoid exposure to sunlight or bright indoor light during the 3 h that the cream is on the skin.
- Inform patients to wear protective hats and clothing if they are required to be outside in the sun. Also, advise patients to avoid exposure to cold temperatures during the 3 h that the cream is on the skin. Advise patients to wear warm clothing and keep treated skin covered if they are required to be outside in cold temperatures.
- Advise patients to tell their health care provider if they experience skin reactions after treatment, such as a burning feeling, blistering, bleeding, crusting, infection, itching, pain, peeling, redness, stinging, swelling, and ulcers. Advise patients to call their health care provider if any skin reactions get worse and last longer than 3 wk.
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