Metvix - Consumer Medicine Information
|Condition:||Actinic Keratosis, Basal Cell Carcinoma, Skin Cancer|
|Ingredients:||methyl aminolevulinate hydrochloride, glyceryl monostearate, cetostearyl alcohol, polyoxyl stearate, cholesterol, oleyl alcohol, glycerol, white soft paraffin, isopropyl myristate, arachis (peanut) oil, refined almond oil, edetate disodium, methylparaben, propylparaben, purified water.|
methyl aminolevulinate topical cream
About This Medication
What the Medication is Used For
METVIX cream is a prescription cream used with photodynamic therapy (PDT or red light treatment) to treat:
- skin growths on the face and scalp called actinic keratosis (AK). METVIX cream is only used for AK skin growths that are thin and not dark coloured. AK skin growths are not cancerous.
- primary superficial basal cell carcinoma (a skin cancer). METVIX cream is NOT used for lesions on the facial H-zone, e.g., ears, nose, upper lip, eyes and temples.
What It Does
The active ingredient in METVIX cream, methyl aminolevulinate is a light sensitive agent. After application of METVIX cream to the skin, it accumulates in the lesions. When the skin lesions are exposed to light (photodynamic therapy), the light causes the drug to react with oxygen, which forms a chemical that kills the precancerous and cancer cells.
When It not Should to be Used
Do not use METVIX cream if:
- you are allergic to methyl aminolevulinate or to any of the ingredients in METVIX or porphyrins
- you are allergic to peanut and almond oil. METVIX contains peanut and almond oil you have skin photosensitivity or porphyria
- you have morpheaform basal cell cancer (a type of basal cell cancer)
What the Medicinal Ingredient Is
methyl aminolevulinate hydrochloride
What the Important Nonmedicinal Ingredient Are
Glyceryl monostearate, cetostearyl alcohol, polyoxyl stearate, cholesterol, oleyl alcohol, glycerol, white soft paraffin, isopropyl myristate, arachis (peanut) oil, refined almond oil, edetate disodium, methylparaben, propylparaben and purified water.
What Dosage Forms It Comes In
METVIX cream, 168 mg/g methyl aminolevulinate (as methyl aminolevulinate hydrochloride), is available as a 2 gram aluminum tube.
Warnings and Precautions
Serious Warnings and Precautions
- The treatment using METVIX cream and light therapy must be provided to you by a doctor who is trained in their use.
- Do not get METVIX cream in your eyes or mucous membranes.
- Patients with superficial basal cell carcinoma must have regular follow-up of their treatment site.
- The long-term efficacy of METVIX for the treatment of superficial basal cell carcinoma has not been established.
BEFORE you use METROGEL, METROCREAM, and METROLOTION talk to your doctor or pharmacist if:
- you are pregnant or planning to become pregnant. It is not known if METVIX cream can harm your unborn baby.
- you are breastfeeding. Many drugs are excreted in human milk. It is not known if METVIX cream passes into your milk and if it can harm your baby.
- you are allergic to nuts or peanuts.
- you have or had skin cancer or other skin growths on your body.
- you have bleeding problems since patients with these problems were not studied.
After METVIX is applied, you must have a special bandage to protect the area for the 3 hours before light therapy. Avoid exposure of the area to natural or artificial light and protect from cold temperatures. After the light therapy, the treated areas should be covered and protected from natural or artificial sunlight for at least 48 hours.
If you are unable to receive the light treatment after METVIX is applied, rinse the area to remove the cream, and protect it from natural and artificial light for at least 48 hours. You must wear special Nitrile gloves when you remove the cream.
Interactions With This Medication
It is not known if METVIX cream and other medicines can affect each other. It is possible that other light sensitive drugs when used at the same time as METVIX cream will increase some of the side effects of METVIX cream, mainly skin reactions when exposed to light (photosensitivity). Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
Interactions with cosmetics, such as soaps and moisturizers, and sunscreens have not been studied.
Proper Use of This Medication
Usual Adult Dose
The treatment consists of 2 treatment sessions; each session is 7 days apart. Each treatment consists of the following steps:
- Lesion debriding – the lesion (affected area) is scraped to remove crusts and scales.
- METVIX cream application – METVIX cream is applied to the lesion.
- Bandage application – the lesion is covered with a special bandage for 3 hours. Avoid exposure of the treated area to natural or artificial light and protect from cold temperatures.
- Cream removal – the special bandage is removed and the treated area is rinsed with saline solution to remove METVIX cream.
- Light therapy (photodynamic therapy or PDT) – the lesion is treated with a red light for about 10 minutes; goggles should be worn to protect the eyes.
More than one lesion can be treated at a time and a maximum of 2 grams of METVIX can be used per session.
Your doctor will need to see you after 3 months to determine if the treatment worked for you. At the 3 month check up, a second 2 treatment sessions of the lesion may be considered if needed.
METVIX cream overdose has not been reported. There is no information on overdose of light following METVIX cream application.
If you miss any session of your scheduled treatment, or any step of each treatment session, contact your doctor’s office for advice.
Side Effect and What to do About Them
The majority of side effects are self limiting reactions at the lesion site, which occur during and immediately after light therapy, and do not require treatment. Very common side effects of METVIX cream with photodynamic therapy treatment include the following skin reactions at the treated site:
- burning feeling
- crusting, peeling, blisters, bleeding, itching, ulcers
Tell your doctor if you get any of these side effects. Your healthcare provider should be able to offer advice on how 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, become severe, or last longer than 3 weeks, call your doctor.
Serious Side Effects how Often They Happen and What to do About Them
|Symptom / effect||Talk with your doctor|
|Only if severe||In all cases|
This is not a complete list of side effects. For any unexpected effects while taking METVIX, contact your doctor or pharmacist.
How to Store It
Store refrigerated, 2-8°C (36-46°F).
Use contents within one week after opening.
Should not be used after 24 hours without refrigeration.
Shelf-life: 18 months.
Reporting Suspected Side Effects
To monitor drug safety, Health Canada through Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance by:
Toll-free telephone: 866-234-2345
Toll-free fax: 866-678-6789
By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance.
The Canada Vigilance program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at:
or by contacting the sponsor, Galderma Canada Inc., at: 1-800-467-2081