Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, United Kingdom
Treatment of thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp when other therapies are considered less appropriate.
Only for treatment of superficial and/or nodular basal cell carcinoma unsuitable for other available therapies due to possible treatment related morbidity and poor cosmetic outcome; such as lesions on the mid-face or ears, lesions on severely sun damaged skin, large lesions, or recurrent lesions.
Treatment of squamous cell carcinoma in situ (Bowen´s disease) when surgical excision is considered less appropriate.
Metvix is indicated in adults above 18 years of age.
For treatment of actinic keratoses (AK) one session of photodynamic therapy should be administered. Treated lesions should be evaluated after three months and if there has been an incomplete response, a second treatment may be given. For treatment of basal cell carcinoma (BCC) and Bowen’s disease two sessions should be administered with an interval of one week between sessions. Before applying Metvix, the lesion surface should be prepared to remove scales and crusts and roughen the surface of the lesions. Nodular BCC lesions are often covered by an intact epidermal keratin layer which should be removed. Exposed tumour material should be removed gently without any attempt to excise beyond the tumour margins.
The daylight treatment may be used to treat mild to moderate AK lesions. One treatment should be given. Treated lesions should be evaluated after three months and if there has been an incomplete response, a second treatment may be given.
The safety and efficacy of Metvix in children below 18 years have not yet been established.
Apply a layer of Metvix (about 1 mm thick) by using a spatula to the lesion and the surrounding 5-10 mm of normal skin. Cover the treated area with an occlusive dressing for 3 hours.
Remove the dressing, and clean the area with saline and immediately expose the lesion to red light with a continuous spectrum of 570-670 nm and a total light dose of 75 J/cm² at the lesion surface. Red light with a narrower spectrum of approximately 630 nm (and a total light dose of 37 J/cm²) giving the same activation of accumulated porphyrins may be used. The light intensity at the lesion surface should not exceed 200 mW/cm².
Only CE marked lamps should be used, equipped with necessary filters and/or reflecting mirrors to minimize exposure to heat, blue light and UV radiation. It is important to ensure that the correct light dose is administered. The light dose is determined by factors such as the size of the light field, the distance between lamp and skin surface and illumination time. These factors vary with lamp type, and the lamp should be used according to the user manual. The light dose delivered should be monitored if a suitable detector is available.
Patient and operator should adhere to safety instructions provided with the light source. During illumination patient and operator should wear protective goggles which correspond to the lamp light spectrum.
Healthy untreated skin surrounding the lesion does not need to be protected during illumination.
Multiple lesions may be treated during the same treatment session.
Lesion responses should be assessed after three months, and at this response evaluation, lesion sites showing non-complete response may be retreated if desired. It is recommended that the response of BCC and Bowen’s disease lesions be confirmed by histological examination of biopsy material. Subsequently, close long term clinical monitoring of BCC and Bowen´s disease is recommended, with histology if necessary.
Metvix daylight treatment can be used if the temperature conditions are suitable to stay comfortably outdoors for 2 hours. If the weather is rainy, or is likely to become so, Metvix daylight treatment should not be used.
A sunscreen should be applied, please see section 4.4. Once sunscreen has dried, scales and crusts should be removed and the skin surface roughened before applying a thin layer of Metvix to the treatment areas. No occlusion is necessary. Patients should go outside after Metvix application or, at the latest, 30 minutes later in order to avoid excessive protoporphyrin IX accumulation which would lead to greater pain on light exposure. In order to minimize pain and ensure maximum efficacy the patient should then stay outdoors for 2 continuous hours in full daylight and avoid going indoors. On sunny days, should the patient feel uncomfortable in direct sunlight, shelter in the shade may be taken. Following the 2 hour exposure period, Metvix should be washed off.
The severity of local phototoxic reactions such as erythema, pain and burning sensation may increase in case of prolonged application time and/or very high red light intensity.
Unopened: 15 months.
28 days after first opening of the container.
Store in a refrigerator (2°C–8°C).
Aluminium tube with internal protective lacquer and a latex seal. Screw cap of HDPE.
Metvix cream is supplied in a tube containing 1g or 2 g cream. Not all pack sizes may be marketed.
No special requirements for disposal.
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