Methyl aminolevulinate (Topical application)

Methyl aminolevulinate is used with photodynamic therapy (light treatment) to treat actinic keratosis (AK) on the face and scalp. Actinic keratoses are skin lesions or growths in areas where the skin has been exposed to the sun. AK usually occurs in older patients with light-colored skin. This medicine is only used for AK skin lesions that are thin and light in color.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress three months after the treatment. This will help your doctor see if the medicine is working properly and check for any unwanted effects.

This medicine makes the treated areas of your skin more sensitive to light. Avoid exposure to sunlight or bright indoor light for 3 hours after the medicine is applied to your skin. This includes medical examination lights, operating room lights, tanning beds, or any lights that are close to you. You should also avoid exposure to sunlight or bright indoor light on the treated skin for 2 days after the light treatment (photodynamic therapy). Cover the treated areas of your skin. If you must go out during daylight hours, wear a protective hat or clothing. Check with your doctor if you have questions about this.

Avoid cold temperatures for 3 hours after the medicine is applied to your skin. Wear warm clothing and cover the treated area if you are in cold places.

In deciding to use a medicine, you and your doctor will consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of methyl aminolevulinate in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any age-related problems that would limit the usefulness of methyl aminolevulinate in older adults.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if there may be an interaction. In these cases, your doctor might need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken with food or specific types of food because interactions may happen. Using alcohol or tobacco with some medicines might also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Allergy to almond oil or
• allergy to peanut oil or
• allergy to porphyrins (e.g., porfimer [Photofrin®], verteporfin [Visudyne®]) or
• photosensitivity (skin sensitive to sunlight), history of—Should not be used in patients with these conditions.

• Bleeding problems or
• Skin cancer or other skin lesions, history of—Use with caution. May worsen side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Breakdown of the skin
• Irritation and redness of the skin
• Scabbing
• Swelling of the eyelid
• Swelling of the skin

Less common

• Discharge at the site of application
• Sores on the skin that do not heal

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• Blurred vision or other change in vision
• Eye redness, irritation, or pain
• Hives or welts
• Itching, scaling, or severe redness of the skin
• Persistent non-healing sore
• Pink growth on the skin
• Reddish patch or irritated area on the skin
• Seeing flashes or sparks of light
• Seeing floating spots before the eyes, or a veil or curtain appearing across part of the vision
• Shiny bump on the skin
• Skin rash, encrusted, scaly and oozing
• White, yellow, or waxy scar-like area on the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Darkening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Metvixia

Methyl aminolevulinate will be applied to your skin in a clinic or doctor's office. You will receive two treatments with this medicine spaced 1 week apart.

Methyl aminolevulinate is for use on the skin only. Do not get it in your eyes, nose, or mouth. If it does get on these areas, tell your doctor right away.