Methyl Aminolevulinate

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

It is possible that other medications that increase your sensitivity to light may increase the sensitivity of skin lesions to red light therapy following application of methyl aminolevulinate cream. Especially tell your doctor if you take certain antibiotics that can increase your sensitivity to sunlight such as ciprofloxacin (Cipro).

This is not a complete list of methyl aminolevulinate drug interactions. Ask your doctor or pharmacist for more information.

• Store under refrigeration.
• Use contents within one week after opening.
• Should not be used after 24 hours out of refrigerator.

• It is used to treat a precancerous skin problem called actinic keratosis.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take methyl aminolevulinate by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• This medicine is used with light therapy.
• Your doctor will put on the skin.
• If you cannot have the light therapy after this medicine has been put on, talk with your doctor. Avoid bright light for as long as you have been told by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Any unexplained bruising or bleeding.
• Redness, swelling, or other skin irritation that gets worse or lasts longer than 3 weeks.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Photosensitizing Agent, Topical
• Topical Skin Product

Refer to adult dosing.

Prepare lesions using a small dermal curette to remove scales and crusts and roughen the surface of the lesion. Wearing nitrile gloves (latex and vinyl gloves do not provide enough protection) and using a spatula, apply a layer of methyl aminolevulinate cream about 1 mm thick topically to prepared lesion and the surrounding 5 mm of normal skin. Multiple lesions may be treated during the same treatment session; do not exceed a treatment field area of 80 x 180 mm. Do not exceed a total of 1 g of Metvixia cream or 2 g Metvix cream [Canadian product] per treatment session.

When used in conjunction with c-PDTL: Occlude the site(s) with a nonabsorbent dressing for 3 hours (minimum 2.5 hours, maximum 4 hours), then remove. Remove excess cream with saline and illuminate with red light following lamp manufacturer's instructions. Following illumination of site, the treated area should be kept covered and away from bright indoor light and sunlight from 48 hours. If red light treatment is interrupted or stopped it may be restarted. However, if for any reason, red light illumination is not done, the cream should be removed within 3 hours (from time of initial application) and the area protected from sunlight or prolonged/intense light for 48 hours. Use in conjunction with Atkilite CL 128 lamp.

When used in conjunction with DL-PDT: Metvix [Canadian product]: Prior to preparing the lesions, sunscreen (≥ SPF 30), that does not include filters which may inhibit absorption of visible light (eg, titanium dioxide, zinc oxide, iron oxide), should be applied to all sun exposed areas including the treatment areas. Occlusion of the treatment site(s) is not necessary. Patients should go outside immediately after therapy or within 30 minutes; remain in daylight for 2 continuous hours, then remove cream with soap and water.

Pain and burning begin during illumination and generally resolve completely within a few minutes or hours, but may last up to a few days. Erythema and other signs generally resolve within a few days up to 3 weeks.

>10%:

Central nervous system: Local discomfort (≤86%; severe: ≤20%)

Dermatologic: Burning sensation of skin (≤86%; severe: ≤20%), skin pain (≤86%; severe: ≤20%), erythema (63%; severe 6%), crusted skin (≤29%), skin blister (≤29%), skin erosion (≤29%), pruritus (22%), exfoliation of skin (14%)

Local: Skin edema (≤18%)

Ophthalmic: Eyelid edema (≤18%)

1% to 10%:

Central nervous system: Localized warm feeling (4%)

Dermatologic: Dermal hemorrhage (2%), hyperpigmentation (2%), skin tightness (2%)

Local: Application site discharge (2%)

<1%, postmarketing, and/or case reports: Angioedema, contact dermatitis, eczema, facial edema, infection (application site), keratitis, macular edema, squamous cell carcinoma of skin, urticaria, vitreous detachment