Patient Leaflet Updated 26-Jun-2024 | Galderma (U.K) Ltd
Metvix 160 mg/g Cream
Metvix 160 mg/g cream
Methyl aminolevulinate
1. What Metvix is and what it is used for
2. What you need to know before you use Metvix
3. How to use Metvix
4. Possible side effects
5. How to store Metvix
6. Contents of the pack and other information
Metvix is used in the treatment of pre-cancerous skin lesions on the face and scalp (known as actinic keratoses), which are areas of the skin that have been damaged by sunlight and become rough and scaly. Having these lesions means that you may be more likely to get skin cancer in the future unless they are treated.
Metvix is also used in the treatment of basal cell carcinoma (BCC), a skin cancer that can cause a reddish, scaly patch (called superficial BCC) or a small bump or a series of small bumps on the skin (called nodular BCC). These lesions bleed easily and do not heal. Metvix is used when other therapies are not suitable.
Metvix can also be used to treat Bowen's disease (a pre-cancerous lesion appearing as slowly enlarging reddish-pink patches) when surgery is not suitable.
The treatment consists of application of Metvix and light exposure. Damaged skin cells absorb methyl aminolevulinate from the cream and are destroyed by light exposure (known as photodynamic therapy). The surrounding healthy skin is not affected.
Talk to your doctor before using Metvix:
Direct eye contact with Metvix should be avoided.
Metvix cream should not be applied to the eyelids and mucous membranes.
The active substance may cause skin allergy which can lead to angioedema. If you experience the following symptoms: swelling of the face, the tongue or the throat; rash, or difficulty in breathing, you should immediately stop taking Metvix and contact a doctor.
If using a red-light source and the application time or the light dose is increased, a more severe skin reaction may result (see Section 4 - Possible side effects).
In very rare cases photodynamic therapy with a red light source may increase the risk to develop temporary memory loss (including confusion or disorientation), in case of symptoms, you should contact your doctor immediately.
Sun exposure and UV therapy
As a general precaution, sun exposure on the treated lesion sites and surrounding skin should be avoided for a couple of days following treatment. If you are being treated with ultraviolet light (UV-therapy), this treatment should be stopped before Metvix treatment.
Treatment with Metvix is not recommended during pregnancy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
No effects on the ability to drive and use machines are expected.
If you are allergic to peanut or soya, (containing arachis oil) do not use this medicinal product. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Methyl- and propyl parahydroxybenzoate (E218, E216) may cause allergic reactions (possibly delayed).
The treatment consists of application of Metvix and light exposure. The illumination source for treatment of actinic keratoses can be daylight (natural or artificial) or a red-light lamp. Your doctor will decide which treatment option to use, depending on your lesions. The illumination source for treatment of basal cell carcinoma and Bowen's disease is always a red-light lamp.
Treatment of actinic keratoses, basal cell carcinoma and Bowen's disease using a red-light lamp
The use of Metvix with a red-light lamp requires specific knowledge in photodynamic therapy. Accordingly, it should be administered in the presence of a doctor, a nurse or another health care professional trained in the use of photodynamic therapy.
Preparation of the lesions and application of the cream
Each skin lesion will be prepared before treatment, by removing scales and crusts and roughening of the skin surface. This preparation helps Metvix and light to get to all parts of the skin lesion. Some skin cancer lesions are covered by an intact layer of skin which will be removed according to your doctor's instructions. Metvix is applied by a spatula in a layer (about 1 mm thick) to the lesions or fields and a small area of the surrounding skin. Direct eye contact with Metvix cream should be avoided. After the cream is applied, the area is covered with a dressing. The dressing is removed and the cream is washed off with saline solution after 3 hours.
Illumination using a red-light lamp
Immediately after cleaning, the treated area is exposed to a red-light. To protect your eyes from the strong light, you will be given goggles to wear during light exposure.
Several lesions or fields may be treated during the same therapy session.
Considerations before treatment
Natural daylight treatment can be used if the temperature is suitable to stay comfortably outdoors for 2 hours. The efficacy of the treatment has been shown to be similar whether the treatment is done on a sunny or cloudy day. If the weather is rainy, or is likely to become so, natural daylight treatment should not be used.
Preparation of the lesions and application of the cream
An appropriate sunscreen should be applied to all areas, including the treatment areas that will be exposed to daylight before lesion or field preparation. Only the sunscreen that has been recommended specifically by your doctor should be used. Do not use sunscreen with physical filters such as titanium dioxide, zinc oxide as these filters would inhibit absorption of visible light and may impact efficacy. Only sunscreens with chemical filters should be used.
Each skin lesion will be prepared before treatment, by removing scales and crusts and roughening of the skin surface. This preparation helps Metvix and light to get to all parts of the skin lesion.
A thin layer of Metvix is applied on the lesions or fields with a spatula or gloved hand. Direct eye contact with Metvix cream should be avoided.
Illumination using natural daylight
You should go outside after Metvix application, or at the latest, 30 minutes later and stay for 2 hours in full daylight or, if needed, in a shaded outdoor area. It is recommended not to go indoors during this time period. 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. Following the 2-hour exposure period Metvix cream is washed off.
Several lesions or fields may be treated during the same therapy session.
The use of Metvix with an artificial daylight lamp requires specific knowledge in photodynamic therapy. Accordingly, it should be administered in the presence of a doctor, a nurse or another health care professional trained in the use of photodynamic therapy.
Preparation of the lesions and application of the cream
Each skin lesion will be prepared before treatment, by removing scales and crusts and roughening of the skin surface. This preparation helps Metvix and light to get to all parts of the skin lesion. A thin layer of Metvix is applied on the lesions or fields with a spatula or gloved hand. Direct eye contact with Metvix cream should be avoided.
Illumination using an artificial daylight source
After the cream is applied, or at the latest, 30 minutes later, the treated area is exposed to artificial daylight for 2 hours. Following the 2 hour-exposure period, Metvix cream is washed off.
Several lesions or fields may be treated during the same therapy session.
Actinic keratoses are treated with one session.
Basal cell carcinoma and Bowen's disease is treated with two sessions, with an interval of one week in between sessions
Follow up
Your doctor will decide how well each skin lesion has responded after three months and may take a small sample (biopsy) of the skin and have the cells examined. Treatment may be repeated after this period if necessary.
Treatment with Metvix is not suitable for use in children or adolescents below 18 years of age.
If the treatment is stopped before the light therapy is started or full light dose is given, when using the red light, or before the end of the 2 h daylight exposure the effectiveness of the treatment might be reduced.
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects below have been reported when using Metvix with red light. The clinical trial studies where Metvix was used with daylight showed similar types of side effects apart from a significant decrease in pain when using daylight.
Very common (may affect more than 1 in 10 people):
skin pain (with red light), skin burning sensation, scab, redness of the skin.
Painful and burning skin sensations at the treatment site during and after light exposure are the most common side effects, occurring in more than half of patients treated. These reactions are usually of mild to moderate severity but rarely require the light therapy to be stopped early. These reactions usually start during light therapy or soon after and last for a few hours, generally improving on the day of treatment. Redness and swelling may persist for 1 to 2 weeks, or occasionally for a longer time period. Repeated treatment does not make these reactions worse.
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from the available data):
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Once opened the cream should be used within 3 months.
Do not use this medicine after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration (e.g. darkening of the colour from pale yellow to brown).
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The colour of Metvix is cream to pale yellow. The cream is available in tubes containing 1 g or 2 g cream.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
PL 10590/0048
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
AT, BE, CZ, DE, DK, EL, ES, FI, IE, IS, IT, LU, NL, NO, PT, SE, SK, UK(NI): Metvix
This leaflet was last revised in May 2024.
P26175-12
Evergreen House North, Grafton Place, London, NW1 2DX, UK
