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Details for: METVIX

Company: GALDERMA CANADA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02323273METVIXMETHYL AMINOLEVULINATE (METHYL AMINOLEVULINATE HYDROCHLORIDE)168 MG / GCREAMTOPICAL
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Summary Reports

Summary Basis of Decision
Regulatory Decision Summary

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

METVIX cream is a prescription cream used with light therapy 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 pre-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.
METVIX cream is used with light therapy either with a red light-emitting diode (LED) light source (for AK and skin cancer) or daylight (for AK only).
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 should not 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 non-medicinal ingredients 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 form 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 receive treatment with METVIX cream 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.
  • you have high blood pressure. Pain associated with METVIX treatment may increase your blood pressure.
  • you are receiving ultraviolet (UV) therapy (e.g., tanning beds, phototherapy for another skin disorder).

METVIX Using a Red LED Light Source (for AK or skin cancer)
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, your healthcare professional will rinse the area to remove the cream. Protect the area where METVIX was applied from natural and artificial light for at least 48 hours.

METVIX Using Daylight (for AK only)
If you are being treated for AK, your doctor may choose to use METVIX with daylight. METVIX with daylight treatment can be used if the temperature is suitable to stay comfortably outdoors for 2 hours (usually when the temperature is above 10°C and below 35°C). If it is raining or snowing, or if it looks like it will rain or snow, METVIX daylight treatment should not be used. Daylight may not be sufficient for METVIX daylight treatment from November to March.

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If you are unable to go outside as planned after your leave the doctor’s office, you should wash the METVIX cream off with soap and water. Protect the area where METVIX was applied from natural and artificial light for at least 48 hours.

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 Dose

METVIX Using a Red LED Light Source (for AK or skin cancer)
For skin cancer, the treatment consists of 2 treatment sessions; each session is 7 days apart.

For AK, the treatment consists of 1 treatment session.

Each treatment consists of the following steps:

  1. Lesion debriding – the lesion (affected area) is scraped with a small dermal curette to remove crusts and scales.
  2. METVIX cream application – METVIX cream is applied to the lesion.
  3. 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.
  4. Cream removal – the special bandage is removed and the treated area is rinsed with saline solution to remove METVIX cream.
  5. Red LED light therapy – 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 (for skin cancer), or 1 treatment session (for AK), of the lesion may be considered if needed.

METVIX Using Daylight (for AK only)
You will receive one treatment with METVIX using daylight.

METVIX daylight treatment can be used if the temperature conditions are suitable for you to stay comfortably outdoors for 2 hours (more than 10°C and less than 35°C). If it is raining or snowing, or if it looks like it will rain or snow, METVIX daylight treatment should not be used.

Each treatment with METVIX using daylight consists of the following steps:

  1. Sunscreen application: Sunscreen is applied to all sun exposed areas, including the treatment areas. The sunscreen used must offer protection from the sun (SPF30 or higher) and should not include physical filters like titanium dioxide, zinc oxide or iron oxide. Only sunscreens with chemical filters should be used. Your doctor will tell you what sunscreen to use.
  2. Lesion debriding: Once sunscreen has dried, the lesion (affected area) is scraped with a small dermal curette to remove crusts and scales.
  3. METVIX cream application: METVIX cream is applied to the lesion. The treated area should be left uncovered.
  4. Daylight therapy: You should go outside right after METVIX application or no later than 30 minutes after application. Once outside, you must stay outdoors for 2 continuous hours in full daylight and avoid going indoors. On sunny days, if you are uncomfortable in direct sunlight, you may go in the shade. Make sure the treatment area is continuously exposed to daylight, and not covered by clothes. It is important to follow these instructions to ensure treatment success and avoid pain during daylight exposure.
  5. METVIX cream removal: Once you have been outdoors for 2 hours, you will need to wash the METVIX cream off with soap and water.

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 treatment session of the lesion may be considered if needed.

Overdose

METVIX cream overdose has not been reported. There is no information on overdose of light following METVIX cream application.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss any session of your scheduled treatment, or any step of each treatment session, contact your doctor’s office for advice.

Side effects 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
  • redness
  • pain
  • stinging
  • swelling
  • crusting, peeling, blisters, bleeding, itching, ulcers
  • infection

The side effects for METVIX using daylight are similar to those seen with METVIX using red LED light. However, there is less pain and skin discomfort with METVIX using daylight compared to Metvix using red LED light.

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 Talk with your doctor In all cases
Common
skin discomfort  
redness  
skin peeling  
headache  
Uncommon
scabbing  
blister  
skin swelling  
eyelid swelling  
face swelling  
tightness of throat  

This is not a complete list of side effects. For any unexpected effects while taking METVIX, contact your doctor or pharmacist.

How to store

Store refrigerated, 2-8°C (36-46°F).

Use contents within one week after opening.

Should not be used after 24 hours without refrigeration.

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found at: http://www.galderma.ca
or by contacting the sponsor, Galderma Canada Inc., at: 1-800-467-2081
This leaflet was prepared by Galderma Canada Inc.

Last revised: March 30, 2017

Date modified: