Metvixia
Generic Name: methyl aminolevulinate hydrochloride
Company: PhotoCure ASA
Date of Approval: July 27, 2004
Treatment for: Actinic Keratosis
FDA Approves Metvixia
The U.S. Food and Drug Administration (FDA) has approved Metvixia, for photodynamic treatment of actinic keratosis (a sun-induced, pre-cancerous skin condition).
Metvixia works in combination with the CureLight lamp, PhotoCure's light source used in the clinical trials.
The novel, non-invasive treatment offered by Metvixia for pre-cancerous skin conditions combines the local application of cream (Metvixia), selectively absorbed into abnormal cells, and illumination with a proprietary red light source (CureLight/Aktilite) to activate the drug.
Metvixia is approved for pre-cancerous skin lesions (actinic keratosis, AK) and non-melanoma skin cancer (basal cell carcinoma, BCC) in most European countries, New Zealand and Australia, and for AK in the US.
Actinic keratosis (AK), also called 'sun spots', is the most commonly diagnosed pre-cancerous skin condition. Worldwide, it is estimated that about 20 million cases of AK occur each year. Early and effective treatment of AK is important as, if left untreated, a certain number of these lesions may progress to squamous cell carcinoma, an aggressive and potentially life-threatening type of skin cancer.
For further information, please visit www.photocure.com
Metvixia Cream Patient Information
Generic name: methyl aminolevulinate hydrochloride
Read this Patient Information before you get treated with Metvixia Cream and each time you get a treatment. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment. Ask your healthcare provider about anything you do not understand about Metvixia Cream.
What is the most important thing I need to know about Metvixia Cream?
- Metvixia Cream with light treatment (Photodynamic therapy or PDT) is only done in medical offices by trained doctors.
- Metvixia Cream is not applied by patients. Metvixia Cream should not be applied by doctors who have not been trained in its use.
What is Metvixia Cream?
Metvixia Cream is a prescription cream used with PDT (light treatment) to treat skin growths on the face and scalp called actinic keratosis (AK). Metvixia Cream is only used for AK skin growths that are thin and not dark colored. AK skin growths are not cancer. AK skin growths are caused partly by too much sun exposure. Metvixia Cream and PDT work together to treat AK skin growths.
Metvixia Cream has not been studied in children for any condition and should not be used in children.
Who should not use Metvixia Cream?
Do not use Metvixia Cream if:
- your skin over reacts to sun or light (photosensitivity)
- you are allergic to porphyrins or to any of the ingredients in Metvixia Cream. The active ingredient is methyl aminolevulinate hydrochloride. Metvixia Cream also contains peanut and almond oil. See the end of this leaflet for a complete list of ingredients in Metvixia Cream.
Before treatment with Metvixia Cream, tell your doctor:
- about your medical conditions, including if you
- are pregnant or planning to become pregnant. It is not known if Metvixia Cream can harm your unborn baby.
- are breastfeeding. It is not known if Metvixia Cream passes into your milk and if it can harm your baby. You should decide whether or not to stop breastfeeding while getting treatment with Metvixia Cream. Talk to your doctor for help with this choice.
- are allergic to nuts or peanuts
- have or had skin cancer or other skin growths on your body
- have bleeding problems.
- about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. It is not known if Metvixia Cream and other medicines can affect each other.
How should I use Metvixia Cream?
- Metvixia Cream and PDT treatment is only done by trained doctors.
- You will receive 2 treatments with Metvixia Cream and PDT 7 days (1 week) apart. Your doctor will check you three months after treatment to see if the treatment worked for you. (See the end of this leaflet for the section "Treatment with Metvixia Cream and PDT.")
- Metvixia Cream is for skin use only. Do not get Metvixia Cream in your eyes, mouth, or nose. Tell your doctor right away if this happens.
What should I avoid while using Metvixia Cream?
During the 3 hours that Metvixia Cream is on your skin:
- Avoid exposure to sunlight or bright indoor light during the 3 hours that Metvixia Cream is on your skin. Wear a protective hat and clothing if you need to be outside in the sun.
- Avoid exposure to cold temperatures during the 3 hours that Metvixia Cream is on your skin. Wear warm clothing and keep your treated skin site covered if you are in cold temperatures.
If for some unavoidable reason you are not treated with the lamp you should
- Carefully rinse off the Cream.
- Avoid exposure to sunlight, prolonged or intense light for two days after treatment.
What are the possible side effects of Metvixia Cream with PDT treatment?
Common side effects of Metvixia Cream with PDT treatment include the following skin reactions at the treated site:
- burning feeling
- redness
- pain
- stinging
- swelling
- crusting, peeling, blisters, bleeding, itching, ulcers
- infection
Tell your doctor if you get any of these side effects. Your healthcare provider should be able to treat these reactions according to standard treatments for such skin reactions. These reactions usually go away within 10 days of treatment. Redness may last for up to 1 month. If any of your skin reactions get worse and last longer than 3 weeks, call your doctor.
These are not all the side effects of Metvixia Cream with PDT. Ask your doctor or pharmacist for more information. General information about Metvixia Cream Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
This leaflet summarizes the most important information about Metvixia Cream. If you would like more information, talk with your doctor. You can ask your doctor for information about Metvixia Cream that is written for health professionals.
What are the ingredients in Metvixia Cream?
Active Ingredient: methyl aminolevulinate hydrochloride
Other Ingredients: Glyceryl monostearate, cetostearyl alcohol, poloxyl stearate, cholesterol, oleyl alcohol glycerin, white petrolatum, isopropyl myristate, refined peanut oil, refined almond oil, edetate disodium, methylparaben and propylparaben. The color of the product is cream to pale yellow.
Treatment with Metvixia Cream and PDT
Your doctor will prepare your skin by gently scraping (debriding) your skin growths before treating with Metvixia Cream and PDT. A small skin scraper is used to remove scales and crusts and to roughen the surface of any skin growths. This is to help Metvixia Cream and PDT to reach all parts of the skin growths.
Metvixia Cream is applied to the actinic keratosis skin growths and to a small area of the skin around the growths.
The treated skin areas will be covered with a special clear bandage for about 3 hours.
During these 3-hours you should avoid exposure of treated area to sunlight or bright indoor light. Exposure to light may make your treated skin area sting or burn. Your treated skin area may turn red or swell (photosensitive reactions). Wear a hat and protective clothes if you are exposed to sunlight during this time. Sunscreens will not help protect your treated skin during this time. In cold weather, your treated skin site should be protected from the cold with warm clothes or you should stay indoors for these 3 hours between the cream and light treatment. The clear bandage will be removed and the area will be rinsed with a saline solution before the PDT (light) treatment.
The skin growth will be treated with PDT. PDT lasts about 10 minutes for each area treated with the lamp. You will wear protective goggles to cover your eyes during this part of the treatment.
More than 1 skin growth may be treated at a time. Your treated skin areas may burn, feel painful, sting, or tingle during light treatment. These symptoms may last for a few hours after the treatment. If you cannot have the light treatment 3 hours after Metvixia Cream is applied, rinse the cream off your skin and you must protect your skin from sunlight and bright indoor light for 2 days.
This product should only be stored in refrigerators in pharmacies and medical offices.
Rx only
Metvixia Cream is a registered trade name of PhotoCure ASA.
Sponsor: PhotoCure ASA, Hoffsveien 48, NO-0377 Oslo, Norway
U.S. Contact: Clementi - King, 161 Washington St., Conshohocken, PA 19428
Manufacturer: Penn Pharmaceutical Services Ltd., Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, UK.
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