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

Metvixia cream is used in combination with red light therapy to treat to treat skin growths on the face and scalp called actinic keratosis of the face and scalp.

Metvixia cream is only used for actinic keratosis skin growths that are thin and not dark colored. Actinic keratosis skin growths are not cancer and are caused partly by too much sun exposure.

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

Before you are treated with Metvixia, tell your doctor about all of your medical conditions. Also tell your doctor about all other medications you use, especially drugs that can make your skin more sensitive to sunlight, such as certain antibiotics, heart or blood pressure medications, diuretics (water pills), sulfa drugs, oral diabetes medications, or NSAID pain or arthritis medicines.

Metvixia is applied by a healthcare provider in a clinic setting. For at least 48 hours after your treatment, avoid exposing treated skin to sunlight, sunlamps, tanning beds, or other bright lights. Sunscreen is not effective enough to protect treated skin from harm caused by bring light during this time. Wear protective clothing whenever you are outdoors. Call your doctor at once if you have severe stinging, burning, redness, oozing, or swelling of treated skin areas, especially if you have these effects for longer than 3 weeks after treatment.

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 Metvixia.

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.

Metvixia is a cream that is applied to your skin lesions before you receive red light treatment. A healthcare provider will apply this medicine in a clinical setting.

Before this medicine is applied, your skin lesions will be gently scraped to remove any scales or crusting. After Metvixia cream 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.

Metvixia 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 Metvixia.

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.

Usual Adult Dose for Keratosis:

Non-hyperkeratotic, nonpigmented actinic keratoses of the face and scalp in immunocompetent patients: Apply directly on lesion(s), up to a total of 1 gram (half tube) per each treatment session. Two sessions one week apart should be administered. Cream application should be followed by photoactivation with Aktilite CL 128 lamp red light illumination.

Prior to application of Metvixia cream, a small dermal curette should be used to remove scales and crusts and to roughen the surface of the lesion(s). An approximately 1 mm-thick layer of cream should be applied with a spatula to each lesion and the surrounding 5 mm of normal skin. The application area should then be covered with an occlusive, nonabsorbent dressing for 3 hours (2.5 to 4 hours). Multiple lesions may be treated during the same session, up to an area of 80 X 180 mm (the area of illumination).

Following removal of the occlusive dressing, clean the area with saline and gauze before beginning Aktilite red light treatment. The light dose to be used is 37 J/cm2, and the lamp should be placed 50 to 80 mm (2 to 3.2 inches) from the skin. The required illumination time (7 to 10 minutes) is calculated automatically. Both the patient and operator should wear appropriate eye protection during illumination and avoid staring into the beam. The illumination stops automatically.

If Aktilite red light treatment is interrupted or stopped for any reason, it may be restarted. If the patient cannot have the red light treatment during the prescribed period after application, the cream should be rinsed off and the patient should protect the exposed area from sunlight and prolonged or intense light for at least 48 hours.

You should not use Metvixia cream 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 Metvixia 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 Metvixia 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.

Because Metvixia cream is applied only when needed prior to red light therapy, you will not be on a dosing schedule.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

Avoid touching the treated skin areas after Metvixia cream has been applied to them. Special gloves must be worn by the healthcare provider while applying this medication, and you should not allow your own fingers to come into contact with the cream on your skin.

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

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

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

Call your doctor at once if you have:

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

Common Metvixia side effects 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 FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on topically applied Metvixia. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.