Methyl aminolevulinate (topical)

Methyl aminolevulinate makes your skin more sensitive to light. It works by causing a reaction with light that can destroy certain types of diseased skin cells.

Methyl aminolevulinate (topical) is used along with red light therapy to treat a skin condition called actinic keratosis of the face and scalp.

Methyl aminolevulinate may also be used for other purposes not listed in this medication guide.

You should not use methyl aminolevulinate if you are allergic to porphyrins, peanuts, or almonds, or if your skin is especially sensitive to light.

You should not use this medicine if you are allergic to methyl aminolevulinate, or if you have:

• an allergy to peanuts or almonds;
• an allergy to porphyrins; or
• if your skin is especially sensitive to light.

To make sure methyl aminolevulinate is safe for you, tell your doctor if you have:

• a bleeding disorder; or
• a history of skin cancer or skin growths.

FDA pregnancy category C. It is not known whether methyl aminolevulinate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether methyl aminolevulinate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Methyl aminolevulinate may cause serious side effects. Call your doctor right away if you have:

• severe stinging, burning, redness, oozing, or swelling of treated skin areas (especially if these effects worsen or last longer than 3 weeks).

Common side effects of methyl aminolevulinate may include:

• skin redness, warmth, burning, stinging, or swelling;
• blisters, skin ulcers; or
• peeling or crusting of treated skin.

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 the FDA at 1-800-FDA-1088.

Methyl aminolevulinate topical is a cream that is applied to your skin lesions before you receive red light treatment. A healthcare provider will apply methyl aminolevulinate in a clinical setting.

Before this medicine is applied, your skin lesions will be gently scraped to remove any scales or crusting. After methyl aminolevulinate is applied, your caregiver will cover the treatment area with a bandage. You will need to leave this bandage in place for 3 hours.

During this 3-hour period, avoid exposure to cold temperatures and sunlight or bright indoor lights. Wear a wide-brimmed hat if you must be outdoors during this time.

After your bandaging is removed, any excess medication will be removed with a saline solution. You will then be ready to receive the light treatment.

You will be given eye-wear to protect your eyes during red light treatment.

You may feel a slight stinging or burning during light therapy. Tell your caregivers if you have any type of severe discomfort.

Methyl aminolevulinate and red light therapy is usually given in two sessions one week apart. Your treatment schedule may be different. Follow your doctor's instructions.

It may take several weeks before you notice improvement in your skin condition. Your doctor will need to check your treated skin 3 months after the end of your last treatment with methyl aminolevulinate.

Your skin lesions may need to be treated more than once, and they may come back after treatment. Talk to your doctor about the number of treatments needed to treat your condition.

Because methyl aminolevulinate (topical) is applied only when needed before red light therapy, you will not have a dosing schedule.

Since methyl aminolevulinate is applied by a healthcare professional in a medical setting, an overdose is unlikely.

Tell your caregivers immediately if any of this medicine gets into your eyes, mouth, or nose.

Do not touch the areas of skin that have been treated after methyl aminolevulinate cream has been applied. The healthcare provider must wear special gloves while applying this medication, and you should not let your fingers touch the cream on your skin.

For at least 48 hours after your treatment, do not expose treated skin to sunlight, sunlamps, tanning beds, or other bright lights. Sunscreen is not strong enough to protect treated skin from damage caused by bright light during this time. Wear protective clothing whenever you are outdoors.

Even if you do not receive the light therapy part of your treatment, you must still protect your skin from light for 48 hours after the cream was applied.

It is unlikely that other drugs you take by mouth or inject will affect methyl aminolevulinate (topical) when applied to the skin. However, many drugs can interact with each other. Inform all your health care providers about every medicine you are using, including prescription and over-the-counter medicines, vitamins, and herbal products.