Metvixia

Metvixia is a prescription medication used to treat a pre-cancerous skin condition for which other kinds of therapy are inappropriate.

Metvixia belongs to a group of drugs called porphyrins. These help to work by increasing the skin's sensitivity to red light therapy. (Red light therapy in combination with Metvixia slows or stops the growth of pre-cancerous skin cells).

This medication comes as a cream that is applied to the skin. This cream is typically applied two times in a doctor's office, one week apart, prior to a special form of light treatment that helps to shrink pre-cancerous skin lesions.

Common side effects of Metvixia affect the skin. These side effects include redness, burning feeling, pain, and swelling. Let your doctor know if you experience any vision problems while being treated with Metvixia cream, as it may cause serious eye problems. Do not get Metvixia into your eyes.

Metvixia is a prescription medication used to treat growths called actinic keratoses on the face and scalp. Actinic keratoses are skin lesions that may develop into cancer if left untreated. Metvixia is used in combination with light therapy for this purpose. The light used is of a certain wavelength (it is red in color) and is emmitted by a lamp at the doctor's office.

This medication may be prescribed for other uses. Ask your doctor or pharamcist for more information.

• Galderma Laboratories, L.P.

• Penn Pharmaceutical Services Ltd.

Serious side effects have been reported with Metvixia. See the "Metvixia" Precautions section.

Side effects were experienced following application of cream and exposure to red light (the illumination phase).

Common side effects of Metvixia with red light therapy include the following:

• redness
• pain
• burning feeling
• stinging
• swelling
• crusting, peeling, bleeding, blisters, itching ulcers

This is not a complete list of Metvixia side effects. Ask your doctor or pharmacist for more information.

Tell your doctor or pharmacist if you have any side effect that bothers you or does not go away.

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

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 Metvixia cream. Especially tell your doctor if you take certain antibiotics that can increase your sensitivity to sunlight such as ciprofloxacin (brand name Cipro).

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

Serious side effects have been reported with Metvixia including the following:

• allergic skin reactions. Tell your doctor right away if you notice any itching or redness when the cream is applied.
• angioedema. Angioedema is a serious allergic reactions that involves swelling of the lips and tongue. Since the cream is applied in an office, you should tell your doctor right away if you start to feel swelling, any discomfort in the facial area, or have difficulty breathing during the treatment session.
• damage to the eyes. It is important that you or your doctor do not get the cream into your eyes. Once your treatment session is complete, you should wash your hands with soap and water to remove any cream that may be on your hand to assure it does not get into your eyes. You will also wear protective eyewear during the light treatment that you will receive after the cream is applied.
• photosensitivity reactions. These are reactions that occur when the skin is exposed to light. Symptoms of photosensitivity reactions can include skin pain, burning, swelling, peeling or other skin changes that may resemble a sunburn. You should try to avoid the sun as much as possbible for two days after treatment. When you do go outside, cover your skin with long sleeves or pants and a wide-brimmed hat. You should also avoid bright indoor lights after the cream is applied to your skin before light therapy.

Do not use Metvixia if you:

• are allergic to Metvixia or any of its ingredients
• are allergic to peanuts or almonds (their oils are used to make the cream)
• have been told you have a weakened immune system
• are allergic to porphyrins (Metvixia belongs to the class of medications called porphyrins)
• skin sensitivity to light

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Metvixia, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Metvixia, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to Metvixia or any of its ingredients
• Have had an allergic reaction to any topical (applied to the skin) products in the past
• Are allergic to peanuts or almonds (their oils are used to make the cream)
• Are allergic to porphyrins (Metvixia belongs to a class of medications called porphyrins)
• Are pregnant or breastfeeding

Tell your doctor about all the medicine you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnany. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Metvixia falls into category C. In animal studies, pregnant animals were given Metvixia by injection into a vein, and some babies had problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if Metvixia crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risks of using Metvixia.

Metvixia comes in cream form and is applied in a doctor's office during two separate sessions that are one week apart. It should only be applied to the skin and is not intended for use by mouth. It should also not be applied to your eyes or used intravaginally.

Before the cream is applied, your doctor will scrape the skin lesions to remove crusts and roughen the surface of the lesions to allow the cream and the light to penetrate deeper into the lesion. Your doctor will apply a small amount of cream to the lesion and will then cover the area with a dressing for 3 hours to make sure the cream penetrates the skin. Since the cream increases your sensitivity to light, your doctor should have you sit in an area away from bright lights. The cream should not be in contact with the skin for over 4 hours.

After three hours, your doctor will remove the dressing and provide you with protective goggles or eye shields to wear. While lying down, your doctor will shine a beam of red light from a lamp called the Aktilite lamp the into the lesion. It is important you do not stare directly into the light to avoid damage to your eyes. The light treatment will last approximately 7-10 minutes. You may experience burning or stinging when the light is applied.

Use this medication exactly as prescribed by your doctor. Your doctor will determine the correct amount of cream to apply in the doctor's office.

Not more than one gram (half a tube) of Metvixiae cream is to be applied per treatment session.

The dose your doctor recommends will depend on the size of the skin lesion.

If Metvixia is administered by a healthcare professional in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

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