Details for: METVIX
Company: GALDERMA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02323273 | METVIX | METHYL AMINOLEVULINATE (METHYL AMINOLEVULINATE HYDROCHLORIDE) | 168 MG / G | CREAM | TOPICAL |
Summary Reports
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.
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:
- Lesion debriding – the lesion (affected area) is scraped with a small dermal curette 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.
- 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:
- 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.
- Lesion debriding: Once sunscreen has dried, the lesion (affected area) is scraped with a small dermal curette to remove crusts and scales.
- METVIX cream application: METVIX cream is applied to the lesion. The treated area should be left uncovered.
- 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.
- 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.
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.
| 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:
- Visiting the Web page on Adverse Reaction Reporting (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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