160 mg / g cream
Methyl aminolevulinate
What Metvix is and what it is used for
Metvix is used to treat skin changes on the face and scalp that can develop into cancer (so-called actinic keratoses ), which means that skin areas have been damaged by sunlight, creating uneven, scaly skin spots. If you have these skin changes and they are not treated, you may be more likely to develop skin cancer in the future.
Metvix is also used to treat basal cell carcinoma (BCC), a skin cancer that can cause reddened, scaly patches (called superficial BCC) or a small lump or several small lumps on the skin (called lump-shaped BCC). These changes bleed easily and do not heal. Metvix is used when other treatments are not suitable.
Metrics can also be used to treat Bowen’s disease (a precursor to cancer that manifests as slow-growing reddish-pink spots) when surgery is not appropriate.
The treatment consists of Metvix and light exposure. The damaged skin cells absorb methyl aminolevulinate from cream one and are destroyed by light exposure (so-called photodynamic therapy ). Surrounding healthy skin is not affected.
What you need to know before using Metvix
Do not use Metvix
- if you are allergic to methylaminolevulinate or any of the other ingredients of this medicine (listed in section 6). Metvix contains peanut oil: Do not use Metvix if you are allergic to peanuts or soy
- if you have a special type of skin cancer with yellowish and whitish spots called morphea-type basal cell carcinoma
- if you have a rare disease called porphyria .
Warnings and cautions
Talk to your doctor before using Metvix:
- if the skin changes are of a certain type (colored, deep or if they are present on the genitals)
- if you have “thick” actinic keratoses
- if you have major skin changes caused by Bowen’s disease
- if you are taking medicines that inhibit the immune system such as steroids or ciclosporin
- if you have Bowen’s disease as a result of arsenic exposure (a harmful chemical)
- if you have or have had high blood pressure
Avoid direct eye contact with Metvix. Metvix should not be applied to the eyelids and mucous membranes.
The active substance may cause skin allergy which may lead to angioedema. If you get the following symptoms: swelling of the face, tongue, or throat; rash, or difficulty breathing, stop using Metvix immediately and contact a doctor.
If the red light is used and the application time or dose is increased, this may result in a more severe skin reaction (see section 4 – Possible side effects ).
In very rare cases, photodynamic therapy with a red light source may increase the risk of developing temporary memory loss (including confusion or disorientation). Contact your doctor immediately in case of such symptoms.
Exposure to sunlight and UV treatment
As a general precaution, sunlight should be avoided on treated and surrounding skin surfaces for a few days after treatment. If you are being treated with ultraviolet light (UV treatment), this treatment should be stopped before treatment with Metvix.
Pregnancy and breastfeeding
The use of Metvix during pregnancy is not recommended.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
No effects on the ability to drive or use machines are known.
Metvix contains peanut oil, cetostearyl alcohol and methyl and propyl parahydroxybenzoate
If you are allergic to peanuts or soy (containing peanut oil), do not use this medicine.
Cetostearyl alcohol can cause local skin reactions (eg contact dermatitis ). Methyl and propyl parahydroxybenzoate (E218, E216) may cause allergic reactions (possibly delayed).
How to use Metvix
The treatment consists of the application of Metvix and light exposure. The light source in the treatment of actinic keratosis can be daylight (natural or artificial) or a lamp with red light. Your doctor will decide which treatment option to use, depending on your skin changes. The light source in the treatment of basal cell carcinoma and Bowen’s disease is always a lamp with a red light.
Adults (including the elderly)
Treatment of actinic keratoses, basal cell carcinoma, and Bowen’s disease with a red light
Using Metvix with a red light lamp requires specific knowledge in photodynamic therapy. The treatment should therefore be given in the presence of a doctor, nurse, or other healthcare professional trained in photodynamic therapy.
Pretreatment of skin changes and application of cream one
Every skin change is pretreated by removing scales and crusts and roughening the surface. This makes it easier for Metvix and light to penetrate to all parts of the skin change. Some skin cancer changes are covered by a retained skin layer that is removed according to your doctor’s instructions.
A layer of Metvix (approximately 1 mm thick) is applied using a spatula to the skin change or treatment area and a small area of the surrounding skin. Avoid contact with the cream with the eyes. After application, cover the area with a bandage. The dressing is removed and the cream is washed off with brine after 3 hours.
Lighting with a lamp with red light
Immediately after cleaning, the treated area is illuminated with a red light. To protect your eyes from the bright light, you will need goggles to wear during the light exposure. Several skin changes or areas can be treated at the same treatment time.
Treatment of actinic keratosis with natural daylight
To think about before treatment
Treatment with natural daylight can be used if the temperature conditions are suitable for staying outdoors for 2 hours. The effect of the treatment is equivalent regardless of whether the treatment takes place on a sunny or cloudy day. If it is raining or is likely to start raining, treatment with natural daylight should not be started.
Pretreatment of skin changes and application of cream one
A suitable sunscreen should be applied to all areas that will be exposed to daylight, including the treatment area, before pre-treating the skin changes. Only the sunscreen that has been specifically recommended by your doctor should be used. Do not use sunscreen that contains physical filters such as titanium dioxide or zinc oxide, as these filters inhibit the absorption of visible light and thus may affect the effect. Only sunscreen with chemical filters should be used.
Every skin change is pretreated by removing scales and crusts and roughening the surface. This makes it easier for Metvix and light to penetrate to all parts of the skin change.
A thin layer of Metvix is applied to the skin change or treatment area. The cream one is applied with a spatula or with gloves on. Avoid contact with the cream with the eyes.
Lighting with natural daylight
You should go outdoors after the application of Metvix, at the latest within 30 minutes, and stay in full daylight or, if necessary, in a shady place for 2 hours. You should not go indoors during this period. Make sure that the treatment area is continuously exposed to daylight, and not covered by clothing. It is important to follow these instructions to ensure the effectiveness of the treatment and to avoid pain during light exposure. Wash off cream one after 2 hours. Several skin changes or areas can be treated at the same treatment time.
Treatment of actinic keratosis with a lamp with artificial daylight
Using Metvix with a lamp with artificial daylight requires specific knowledge in photodynamic therapy. The treatment should therefore be given in the presence of a doctor, nurse, or other healthcare professional trained in photodynamic therapy.
Pretreatment of skin changes and application of cream one
Every skin change is pretreated by removing scales and crusts and roughening the surface. This makes it easier for Metvix and light to penetrate to all parts of the skin change. A thin layer of Metvix is applied to the skin change or treatment area. The cream one is applied with a spatula or with gloves on. Avoid contact with the cream with the eyes.
Lighting with artificial daylight
Immediately after the application of Metvix, or for a maximum of 30 minutes thereafter, the treated skin area is illuminated with artificial daylight for 2 hours. After 2 hours, the cream is washed off.
Several skin changes or areas can be treated at the same treatment time.
Number of treatments
- Actinic keratosis is treated at one time.
- Basal cell carcinoma and Bowen’s disease are treated on two occasions, one week apart.
Follow-up
After 3 months, your doctor will assess how well each skin change has responded to the treatment. The doctor can take a small piece of skin (skin biopsy) and have the cells examined. The treatment can be repeated if this is necessary.
Use for children and adolescents
Treatment with Metvix is not suitable for children and adolescents under 18 years of age.
If you stop using Metvix
If the treatment is stopped before the light treatment has started or before the full light dose has been given, when a red light is used, or with a daylight exposure shorter than 2 hours, the effect of the treatment can be reduced.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects listed below have been reported with the use of Metvix with red light. In clinical trials where Metvix was used in daylight, similar types of side effects were seen in addition to a significant reduction in pain during daylight exposure.
Very common (may affect more than 1 in 10 people): skin pain (with red light), burning sensation in the skin, scabs, redness of the skin.
Pain and a burning sensation in the treatment area during and after light exposure are the most common side effects and occur in more than half of treated patients. These reactions are usually mild to moderate and rarely require discontinuation of light therapy. These reactions usually occur in connection with or shortly after the light treatment and last a few hours but usually disappear during the day of treatment. Redness and swelling may persist for 1-2 weeks, in some cases for a longer time. Repeated treatment does not aggravate these reactions.
Common (may affect up to 1 in 10 people):
- Reactions in the treatment area: numbness, stinging and tingling sensation, bleeding (may occur after preparatory treatment of the skin change), hot skin, infection , open wounds (ulceration), swelling / edema of the skin, blisters, itching , scaling, exfoliating wounds.
- Reactions from the rest of the body: headache, feeling hot.
Uncommon side effects (may affect up to 1 in 100 people):
- Reactions in the treatment area: skin irritation, hives , rash, areas with paler or darker skin after healing, photosensitivity, feeling of discomfort, eye swelling, eye pain, nausea, heat rash, fatigue.
No known frequency (can not be calculated from the available data):
- Allergic reaction that may lead to angioedema with the following symptoms: swelling of the face, tongue or throat, or difficulty breathing.
- Eyelid swelling, pustules and eczema (dry flaky skin) at the application site and signs of contact allergy.
- Increased blood pressure can be caused by pain associated with the use of red light.
- Temporary memory loss (including confusion or disorientation).
How to store Metvix
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 ° C – 8 ° C).
After opening, cream one should be used within 28 days.
Do not use this medicine after the expiry date which is stated on the carton and tube. The expiration date is the last day of the specified month.
Do not use this medicine for obvious signs of deterioration (ie if the cream is darkened from pale yellow to brown).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is methylaminolevulinate 160 mg / g (as hydrochloride).
- The other ingredients are self-emulsifying glyceryl monostearate, cetostearyl alcohol, polyoxyl 40 stearate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), disodium edetate, glycerol , white petroleum jelly, cholesterol , isopropylneamoleyl mandolate, water isopropylmyristol mandolate.
What the medicine looks like and contents of the pack
Metvix is cream-colored to pale yellow. Metvix is supplied in a tube containing 1 g or 2 g of cream. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Penn Pharmaceutical Services Ltd.
Tafarnaubach Industrial Estate
Tredegar, Gwent NP22 3AA, UK
or
GALDERMA Laboratories
ZI Montdésir
74540 ALBY-SUR-CHÉRAN, France
This medicinal product is authorized under the European Economic Area under the names:
AT, BE, CZ, DE, DK, EL, ES, FI, IE, IS, IT, LU, NL, NO, PT, SE, SK, UK: Metvix