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Trade Names:
Metvixia
- Cream 16.8%

Mechanism of Action

Pharmacology

Photosensitization of actinic keratosis lesions using methyl aminolevulinate plus illumination with red light of 570 to 670 nm wavelength is the basis for this photodynamic therapy.

Pharmacokinetics

Onset

After application of methyl aminolevulinate cream for 28 h and subsequent illumination with red light, complete photobleaching of protoporphyrin IX occurred with levels of protoporphyrin IX returning to pretreatment values within 1 h after illumination.

Indications and Usage

Treatment of nonhyperkeratotic actinic keratosis of the face and scalp in immunocompetent patients when used in combination with 570 to 670 nm wavelength red-light illumination and debridement.

Contraindications

Cutaneous photosensitivity; known allergies to porphyrins; hypersensitivity to any component of the product, including peanut and almond oil.

Dosage and Administration

Topical Photodynamic therapy is a multistage process involving 2 treatment sessions 7 days apart that include lesion debriding, application of methyl aminolevulinate cream, removal of dressing and rinsing off of excess cream, and illumination of treated lesions. Do not apply more than 1 g of methyl aminolevulinate cream per treatment session.

General Advice

• This product is only dispensed to health care providers and is not intended for application by patients or unqualified medical personnel.
• Red-light treatment must be administered within 3 h of cream application.
• Avoid inadvertent skin contact when applying the cream.
• Wear nitrile gloves when applying and removing the cream; vinyl and latex gloves do not provide adequate protection.
• Appropriate protective sleeves obtained from the product manufacturer must be used with the red-light treatment to decrease risk of blood-borne transmitted diseases (eg, hepatitis, HIV).
• After illumination of the cream, keep the treated area covered and away from light for at least 48 h.
• Patient, operator, and other people present should wear protective goggles that sufficiently screen out light with wavelengths from 570 to 670 nm during red-light treatment.

Storage/Stability

Refrigerate at 36° to 46°F. Use contents within 1 wk of opening. Do not use after 24 h out of refrigerator.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Local

Burning skin sensation (50%); erythema (46%); skin pain (21%); skin stinging (19%); crusting, skin edema (15%); pruritus/itching (13%); blisters, skin peeling (11%); bleeding skin (8%); skin ulceration (5%); basal or squamous cell carcinoma, skin infection (2%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Not recommended for use in children.

Hypersensitivity

Product is formulated with refined peanut and almond oil.

Photosensitivity

Because the treatment site will become photosensitive during the time period between application of the cream and exposure to red-light illumination, patients should avoid exposure of the treatment sites to sunlight or bright indoor light (eg, examination lamps, tanning beds).

Allergenicity

A high rate of contact sensitization has been demonstrated.

Overdosage

Symptoms

Has not been reported.

Patient Information

• Instruct patient to discuss patient information leaflet with health care provider.
• Caution patient that sunscreens will not protect against photosensitivity.