Metvix

Patient information leaflet

Metvix 160 mg/g cream

Methyl aminolevulinate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

1. What Metvix is and what it is used for
2. What you need to know before using Metvix
3. How to use Metvix
4. Possible side effects
5. How to store Metvix
6. Contents of the pack and other information

1. What Metvix is and what it is used for

Metvix is indicated for the treatment of pre-cancerous skin lesions of the face and scalp
(known as actinic keratoses), which appear as rough, scaly skin areas resulting from
damage due to sun exposure. If left untreated, these lesions may increase the risk of developing
skin cancer over time.
Metvix is also indicated for the treatment of basal cell carcinoma (BCC), a type of skin cancer
that may cause a red, scaly patch (known as superficial BCC) or a small bump or a series of small bumps on the skin (known as nodular BCC). These
lesions bleed easily and do not heal. Metvix should be used when other treatment options are considered inappropriate.
Metvix may also be used in the treatment of Bowen’s disease (a pre-cancerous condition characterized by slowly enlarging pink-red patches) when surgery is not appropriate.
The treatment involves application of Metvix followed by exposure to light. Damaged skin cells absorb methyl aminolevulinate from the cream and are destroyed upon exposure to light (a process known as photodynamic therapy). The surrounding healthy skin tissue remains unaffected.

2. What you need to know before using Metvix

Do not use Metvix

• if you are allergic to methyl aminolevulinate or to any of the other ingredients of this medicine (listed in section 6). Metvix contains peanut oil (peanut oil): do not use this product if you are allergic to peanuts or soya
• if you have a particular type of skin tumour with whitish-yellow patches called morpheaform basal cell carcinoma
• if you have a rare disease called porphyria.

Warnings and precautions
Talk to your doctor before using Metvix:

• if your skin lesions are of a certain type (pigmented, deep-seated, or located on the genitals)
• if you have "thick" actinic keratoses
• if you have extensive lesions caused by Bowen’s disease
• if you are taking medicines that suppress the immune system, such as steroids or cyclosporine
• if your Bowen’s disease was caused by exposure to arsenic (a harmful chemical)
• if you have a history of high blood pressure

You must avoid direct contact of Metvix with the eyes. Metvix cream must not be applied to the eyelids or mucous membranes.
The active substance may cause skin allergy which could lead to angioedema. If you experience the following symptoms: swelling of the face, tongue or throat; skin rash; or difficulty breathing, stop using METVIX immediately and contact your doctor.
If red light is used and the frequency of applications or light dose is increased, a more severe skin reaction may occur (see section 4 Possible side effects).
Very rarely, photodynamic therapy with red light might increase the risk of temporary memory loss (including confusion or disorientation). If these symptoms occur, contact your doctor immediately.

Sun exposure and UV light therapy
As a general precaution, you should avoid sun exposure to the treated lesion sites and surrounding skin for a couple of days after treatment.
If you are undergoing treatment with ultraviolet light (UV light therapy), stop this treatment before starting treatment with Metvix.

Pregnancy and breastfeeding
Treatment with Metvix is not recommended during pregnancy.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine.

Driving and using machines
No effects on the ability to drive or operate machinery have been reported.

Metvix contains peanut oil (peanut oil), cetostearyl alcohol, and methyl and propyl parahydroxybenzoate
If you are allergic to peanuts or soya (containing peanut oil), do not use this medicine.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Methyl and propyl parahydroxybenzoate (E218, E216) may cause allergic reactions (including delayed reactions).

3. How to use Metvix

The treatment consists of applying Metvix and exposing the area to light. The light source
for the treatment of actinic keratoses may be daylight (natural or artificial) or a
red light lamp. The doctor will decide which treatment option to use, depending on the
lesions. The light source for the treatment of basal cell carcinoma and Bowen’s disease
is always a red light lamp.
Adults (including elderly people)
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 of photodynamic therapy. Therefore, it must be administered under the supervision of a doctor, nurse, or other healthcare professional trained in photodynamic therapy.
Lesion preparation and cream application
Prepare the surface of each skin lesion before treatment by removing scales, crusts, and thickened areas of skin. This preparation helps Metvix and light reach all parts of the skin lesion. Some skin tumours are covered by an intact layer of skin that must be removed according to the doctor’s instructions.
Apply a thin layer of Metvix (approximately 1 mm thick) to the lesions or fields and to a small area of surrounding skin using a spatula. Avoid direct contact of Metvix cream with the eyes. After applying the cream, cover the treated area with a dressing. After 3 hours, remove the dressing and wash off the cream with saline solution.
Irradiation using a red light lamp
Immediately after washing off the cream, expose the treated area to red light. To protect your eyes from bright light, protective glasses will be provided for you to wear during light exposure. Multiple lesions or fields may be treated during the same therapy session.
Treatment of actinic keratoses with natural sunlight
Considerations before treatment
Treatment with Metvix using natural sunlight may be used only if the temperature allows you to comfortably stay outdoors for 2 hours. The effectiveness of treatment has been shown to be similar whether treatment is performed on a sunny or cloudy day. If the weather is rainy or likely to become so, treatment with Metvix using natural sunlight must not be used.
Lesion preparation and cream application
Adequate sun protection should be applied to all areas, including treatment areas that will be exposed to daylight before lesion preparation or field preparation. Only sunscreen specifically recommended by your doctor should be used. Do not use sunscreens containing physical filters such as titanium dioxide or zinc oxide, as these filters may inhibit absorption of visible light and could affect treatment efficacy. Only sun-protective creams containing chemical filters should be used.
Each skin lesion will be prepared before treatment by removing scales and crusts and making the skin surface rough. This preparation helps Metvix and light reach all parts of the skin lesion.
A thin layer of Metvix should be applied to the lesions or fields using a spatula or a gloved hand. Direct contact of Metvix cream with the eyes must be avoided.
Irradiation using natural sunlight
After application of Metvix, or no later than 30 minutes after, you must go outdoors and remain in full sunlight for 2 hours, or, if necessary, in a shaded outdoor area. You are advised not to go indoors during this time. Ensure that the area to be treated is continuously exposed to sunlight and not covered by clothing. It is important to follow these instructions to ensure treatment success and to avoid pain during sunlight exposure. After the 2-hour exposure period, Metvix cream must be removed with water.
Multiple lesions or fields may be treated during the same therapy session.
Treatment of actinic keratoses using an artificial daylight lamp
The use of Metvix with an artificial daylight lamp requires specific knowledge of photodynamic therapy. Therefore, it must be administered under the supervision of a doctor, nurse, or other healthcare professional trained in photodynamic therapy.
Lesion preparation and cream application
Each skin lesion will be prepared before treatment by removing scales and crusts and making the skin surface rough. This preparation helps Metvix and light reach all parts of the skin lesion. A thin layer of Metvix is applied to the lesions or fields using a spatula or a gloved hand. Direct contact of Metvix cream with the eyes must be avoided.
Irradiation using an artificial daylight light source
After application of the cream, or no later than 30 minutes after, the treated area is exposed to the artificial daylight lamp for 2 hours. After the 2-hour exposure period, Metvix cream must be washed off.
Multiple skin lesions or fields may be treated during the same therapy session.
Number of treatments

• Actinic keratoses are treated with one session
• Basal cell carcinoma and Bowen’s disease are treated with two sessions, one week apart.

Follow-up
Three months after treatment, your doctor will assess how each skin lesion has responded and may take a small skin sample (biopsy) for cellular examination. Treatment may be repeated after this period, if necessary.
Use in children and adolescents
Treatment with Metvix is not appropriate for children or adolescents under 18 years of age.
If you interrupt treatment with Metvix
If you interrupt treatment before undergoing light therapy or receiving the full light dose when using red light, or before completing the second hour of sunlight exposure, the effectiveness of treatment may be reduced.
If you have any doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported during the use of Metvix with red light. Clinical studies,
in which Metvix was used with sunlight, showed similar types of side effects, but with a significant
reduction in pain when sunlight was used.
Very common (may affect more than 1 in 10 people): skin pain (with red light), burning sensation of the skin, crust formation, skin redness.
Skin pain and burning sensations at the application site during and after light exposure are the most
common side effects, reported in more than half of treated patients.
These reactions are usually mild to moderate in severity, but rarely require premature interruption of
light therapy. These reactions usually occur during light treatment or immediately afterwards and last
for a few hours, generally improving on the same day of treatment. Redness and swelling may last
from 1 to 2 weeks or occasionally longer. Repeated treatment does not worsen these reactions.
Common (may affect up to 1 in 10 people):

• Effects at the treatment site: numbness, prickling or tingling sensation, bleeding (may occur following lesion preparation), warmth of the skin, infection, open wounds (ulceration), swelling/skin edema, blisters, itching, skin peeling, exudation.
• Effects not involving the treatment site: headache, sensation of warmth.

Uncommon (may affect up to 1 in 100 people):

• Effects at the treatment site: skin irritation, urticaria, skin rash, areas of darker or lighter skin after healing, light sensitivity, discomfort, eye swelling, eye pain, nausea, heat rash, fatigue.

Not known (frequency cannot be estimated from the available data):

• Allergic reactions which may cause angioedema with the following symptoms: swelling of the face, tongue or throat, or breathing difficulties.
• Eyelid swelling, pustules and eczema (dry, peeling skin) at the application site, and signs of contact allergy.
• Increase in blood pressure, which may be induced by pain associated with the use of red light.
• Temporary memory loss (including confusion or disorientation).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metvix

Keep this medicine out of the sight and reach of children.
Store in the refrigerator (2 °C - 8 °C).
After opening, the cream must be used within 28 days.
Do not use this medicine after the expiry date 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 any visible signs of deterioration (e.g., change in colour from pale yellow to brown).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Metvix contains

• The active substance is methyl aminolevulinate 160 mg/g (as hydrochloride).
• The excipients are glycerol monostearate, cetostearyl alcohol, polyoxyl 40 stearate, methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216), disodium edetate, glycerol, white soft paraffin, cholesterol, isopropyl myristate, peanut oil (peanut oil), almond oil, oleic alcohol, purified water.

Description of the appearance of Metvix and pack contents
The colour of Metvix ranges from cream to light yellow. The cream is available in tubes containing 1 g or 2 g of cream. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GALDERMA Italia S.p.A.
Via dell’Annunciata, 21 - Milan
Manufacturer
Penn Pharmaceutical Services Ltd.
Tafarnaubach Industrial Estate
Tredegar, Gwent
NP22 3AA
United Kingdom
Or
Laboratoires GALDERMA
ZI Montdésir
74540 ALBY SUR CHERAN
France

This medicinal product is authorised in the European Economic Area member states with the following names: Austria, Belgium, Czech Republic, Germany, Denmark, Greece, Spain, Finland, Ireland, Iceland, Italy, Luxembourg, Netherlands, Norway, Portugal, Sweden, Slovakia, United Kingdom: Metvix

Detailed and up-to-date information on this medicinal product is available by scanning the QR code reported on the package leaflet and outer packaging with a smartphone. The same information is also available at the following URL:
https://galdermainfo.it/metvix/ .