METVIX 160 mg/g CREAM

1. What Metvix is and what it is used for

Metvix is used to treat pre-cancerous skin lesions on the face and scalp (known as actinic keratosis) that are areas of damaged skin caused by sunlight and have become rough and scaly. Having these lesions means you may have a higher risk of skin cancer in the future unless they are treated.

Metvix is also used to treat basal cell carcinoma (BCC), a type of skin cancer that can cause red, scaly patches (called superficial BCC) or a small lump or a series of small lumps on the skin (called nodular BCC). These lesions bleed easily and do not heal. Metvix is used when other treatments are not suitable.

Metvix may also be used to treat Bowen's disease (a pre-cancerous lesion that appears as red to pink patches that slowly enlarge), when surgery is not suitable.

The treatment involves applying Metvix and exposing it to light. The damaged cells absorb the methyl aminolevulinate from the cream and are destroyed by the light (a process known as photodynamic therapy). The healthy skin around the lesions is not affected.

2. What you need to know before starting to use Metvix

Do not use Metvix:

• if you are allergic to methyl aminolevulinate or any of the other ingredients of this medication (listed in section 6). Metvix cream contains peanut oil: do not use this medication if you are allergic to peanuts or soya.
• if you have a certain type of skin cancer with white-yellowish patches called morpheaform basal cell carcinoma.
• or if you have a rare disease called porphyria.

Warnings and precautions

Consult your doctor before starting to use Metvix: your doctor will consider whether the following may be important for you.

• if the skin lesions are of a certain type (colored, deep, or located in the genital area).
• if you have "thick" actinic keratosis lesions.
• if you have extensive lesions caused by Bowen's disease.
• if you are taking medications that suppress your immune system, such as steroids or cyclosporin.
• if your Bowen's disease has been caused by exposure to arsenic (a harmful chemical).
• if you have a history of high blood pressure.

You should avoid contact between Metvix and your eyes. Metvix cream should not be applied to the eyelids or mucous membranes.

The active ingredient methyl aminolevulinate can cause skin allergy, resulting in angioedema. If you experience the following symptoms: swelling of the face, tongue, or throat; rash or difficulty breathing, you should stop treatment with Metvix and contact your doctor.

If you use a red light source and increase the application time or light intensity, a more severe skin reaction may occur (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); if you experience symptoms, you should contact your doctor immediately.

Sunlight exposure and UV therapy

As a general precaution, you should avoid sun exposure of the treated areas and surrounding skin for two days after treatment. If you are being treated with ultraviolet light (UV therapy), this treatment should be stopped before treatment with Metvix.

Pregnancy and breastfeeding

Treatment with Metvix is not recommended during pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking any medication.

Driving and using machines

No effects on the ability to drive or use machines are expected.

Metvix contains peanut oil, cetyl alcohol, and methylparaben and propylparaben.

If you are allergic to peanut oil or soya, do not use this medication. Metvix also contains cetyl alcohol, which may cause local skin reactions (contact dermatitis). Methylparaben and propylparaben (E-218, E-216) may cause allergic reactions (possibly delayed).

3. How to use Metvix

The treatment involves applying Metvix and exposing it to light. The light source for the treatment of actinic keratosis 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 light source for the treatment of basal cell carcinoma and Bowen's disease is always a red light lamp.

Adults (including elderly patients)

Treatment of actinic keratosis, basal cell carcinoma, and Bowen's disease with a red light lamp

The use of Metvix with a red light lamp requires specific knowledge of photodynamic therapy. Consequently, it should be administered in the presence of a doctor, nurse, or other healthcare professional trained in the use of photodynamic therapy.

Preparation of the lesions and application of Metvix

Each skin lesion will be prepared before treatment by removing scales and crusts and scraping the skin surface. This preparation helps Metvix and light reach all parts of the 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 with a spatula as a layer (about 1 mm thick) over the lesions or cancerous fields and over a small area of surrounding skin. You should avoid direct contact between Metvix and your eyes. After applying the cream, the treated area is covered with a dressing. The dressing is removed, and then the cream is removed by washing after 3 hours.

Light exposure using a red light lamp

Immediately after washing, the treated area is exposed to red light. To protect your eyes from the intense light, you will be given glasses to wear during light exposure.

During the same treatment session, multiple cancerous fields or lesions can be treated.

Treatment of actinic keratosis with natural daylight

Considerations before treatment

Treatment with Metvix natural daylight can be used if the temperature conditions are suitable for staying comfortably outdoors for 2 hours. The efficacy of the treatment has been shown to be similar whether the treatment is performed on a sunny or cloudy day. If the weather is rainy, or there is a chance of rain, you should not use the treatment with Metvix natural daylight.

Preparation of the lesions and application of Metvix

Before preparing the lesion or cancerous field, a suitable sunscreen should be applied to all areas, including the treatment areas that will be exposed to daylight. Only the sunscreen recommended by your doctor should be used. Do not use sunscreens with physical filters such as titanium dioxide or zinc oxide, as these filters inhibit the absorption of visible light and may affect the efficacy.

Only sunscreens with chemical filters should be used.

Each skin lesion will be prepared before treatment by removing scales and crusts and scraping the skin surface. This preparation helps Metvix and light reach all parts of the lesion.

A thin layer of Metvix should be applied with a spatula or glove over the lesion or cancerous field. You should avoid direct contact between Metvix and your eyes.

Light exposure with natural daylight

You should go outside after applying Metvix or at least 30 minutes after and stay in full daylight for 2 hours or, if necessary, in a shaded outdoor area. It is recommended not to be indoors during this period. Make sure the treatment area is continuously exposed to daylight and not covered by clothing. It is essential to follow these instructions to ensure the success of the treatment and avoid pain during light exposure. After the 2-hour exposure period, Metvix should be removed by washing.

During the same treatment session, multiple cancerous fields or lesions can be treated.

Treatment of actinic keratosis with artificial daylight lamp

The use of Metvix with an artificial daylight lamp requires specific knowledge of photodynamic therapy. Consequently, it should be administered in the presence of a doctor, nurse, or other healthcare professional trained in the use of photodynamic therapy.

Preparation of the lesions and application of Metvix

Each skin lesion will be prepared before treatment by removing scales and crusts and scraping the skin surface. This preparation helps Metvix and light reach all parts of the lesion. A thin layer of Metvix should be applied over the lesions or cancerous fields with a spatula or glove. You should avoid direct contact between Metvix and your eyes.

Light exposure with an artificial daylight lamp

After applying the cream, or at most 30 minutes after, the treated area is exposed to artificial daylight for 2 hours. After the 2-hour exposure period, Metvix should be removed by washing. During the same treatment session, multiple cancerous fields or lesions can be treated.

Number of treatments

• For the treatment of actinic keratosis, one session of photodynamic therapy will be applied.
• For the treatment of basal cell carcinoma and Bowen's disease, two sessions will be applied, with a one-week interval between sessions.

Follow-up

Your doctor will decide, after three months, whether your lesion has responded adequately and may take a small sample (biopsy) of the skin and examine the cells. The treatment can be repeated after this period if necessary.

Use in children and adolescents

Treatment with Metvix is not suitable for children and adolescents under 18 years of age.

If you stop using Metvix

If you stop treatment before starting light therapy or receiving a full dose of light, when using red light, or before the end of the 2-hour daylight exposure, the efficacy of the treatment may be reduced.

If you have any further questions about the use of this medication, ask your doctor.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following side effects have been reported when using Metvix with red light. Studies of clinical trials where Metvix was used with daylight showed similar side effects, apart from a significant decrease in pain when using daylight.

Very common (may affect more than 1 in 10 patients):skin pain (with red light), burning sensation of the skin, crust, redness of the skin.

Pain and burning sensations at the treatment site during and after light exposure were the most common side effects, occurring in more than half of the patients treated. These local reactions are generally mild or moderate in severity but rarely require interruption of light therapy. 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 or 2 weeks, or occasionally for a longer period. Repeating the treatment does not make these reactions worse.

Common (may affect up to 1 in 10 patients):effects at the treatment site: numbness, tingling, or itching, bleeding (may occur after lesion preparation), heat on the skin, infection, open sores (ulceration), swelling/edema of the skin, blisters, itching, skin peeling, suppuration.

Effects outside the treatment site: headache, and feeling of heat.

Uncommon (may affect up to 1 in 100 patients):effects at the treatment site: skin irritation, urticaria, areas of skin that are paler or darker after healing, sensitivity to light, photosensitivity reaction, discomfort, eye swelling, eye pain, nausea, rash, and fatigue.

Frequency not known (frequency cannot be estimated from available data):

• Allergic reaction that can cause angioedema with the following symptoms: swelling of the face, tongue, or throat, or difficulty breathing.
• Temporary memory loss (including confusion or disorientation).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Metvix

Keep this medication out of the sight and reach of children.

Store in a refrigerator (between 2°C and 8°C).

Once the tube is opened, the cream should be used within 3 months.

Do not use this medication after the expiration date stated on the carton and tube after EXP. The expiration date is the last day of the month indicated.

Do not use this medication if you notice visible signs of deterioration (e.g., darkening of the pale yellow color to brown).

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Metvix

• The active ingredient is methyl aminolevulinate 160 mg/g (as hydrochloride).
• The other ingredients are glyceryl monostearate, cetyl alcohol, polyoxyl 40 stearate, methylparaben (E-218), propylparaben (E-216), disodium edetate, glycerol, light liquid paraffin, cholesterol, isopropyl myristate, peanut oil, refined almond oil, oleic alcohol, and purified water.

Appearance and packaging of the product

The cream is pale yellow to cream-colored. The cream is packaged in tubes containing 2 g of cream.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Laboratoire GALDERMA

ZI Montdésir

74540 ALBY SUR CHERAN

France

or

Galderma Laboratorium GmbH

Toulouser Allee 23a

40211 Düsseldorf

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Metvix: Austria, Belgium, Czech Republic, Germany, Denmark, Greece, Spain, Finland, Ireland, Iceland, Italy, Luxembourg, Netherlands, Norway, Portugal, Sweden, Slovakia, United Kingdom

Date of the last revision of this leaflet: June 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es