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Methyl aminolevulinate cream 16%

Updated 2 Feb 2023 | Photodamaged skin treatments


Cream containing methyl aminolevulinate (as hydrochloride).

Drugs List

  • methyl aminolevulinate 16% cream
  • METVIX 16% cream
  • Therapeutic Indications


    Squamous cell carcinoma in-situ (Bowen's disease)
    Thin/non-hyperkeratotic and non-pigmented actinic keratoses on face & scalp
    Treatment of nodular basal cell carcinoma (other treatment unsuitable)
    Treatment of superficial basal cell carcinoma (other treatment unsuitable)

    Treatment of thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face or scalp when other therapies, due to treatment related morbidity or cosmetic outcome, are considered less appropriate.

    Treatment of superficial and/or nodular basal cell carcinoma unsuitable for other available therapies 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.


    Methyl aminolevulinate should only be administered in the presence of a physician, nurse or other healthcare professional experienced in the use of photodynamic therapy.


    For the treatment of actinic keratoses, one session of photodynamic therapy should be administered. Treated lesions should be evaluated after 3 months and if needed, another therapy session may be administered.

    For the treatment of basal cell carcinoma and squamous cell carcinoma in-situ two sessions should be administered with an interval of 1 week between sessions.

    Photodynamic therapy

    Prior to treatment the surface of the lesions must be prepared by removing scales and crusts and to roughen the surface. Nodular basal cell carcinomas should have any intact epidermal keratin layer removed. Exposed tumour material should be removed gently with no attempt to excise beyond the tumour margins.

    Using a spatula, apply a 1 mm thick layer of cream to the lesion and 5 to 10 mm of surrounding normal skin. Cover with an occlusive dressing for 3 hours.

    Healthy untreated skin surrounding the lesion does not need protection. Multiple lesions may be treated during the same treatment session. Patients should be advised to avoid sunlight or other UV sources for 48 hours after treatment.

    Remove the dressing, clean the treated area with saline and immediately expose the lesion to red light only from a CE marked lamp with the necessary filters and/or reflecting mirrors to minimise exposure to the emitted heat, blue light and UV radiation. Use a continuous spectrum of 570 to 670 nm and a total light dose of 75 J/ centimetre squared at the lesion surface. Alternatively red light with a narrower spectrum giving the same activation of accumulated porphyrins may be used. The light intensity at the lesion surface should not exceed 200 mW/ centimetre squared. The correct light dose should be determined by factors such as illumination time, size of light field and distance between lamp and skin surface. These factors vary with lamp type and the lamp's operating manual should be consulted. The light dose should be monitored if an appropriate detector is available.

    Lesion response should be assessed after 3 months. It is recommended that this assessment be confirmed by histological examination of biopsy material. Non-responsive lesions should be retreated if required. Close clinical monitoring of patients with Bowen's disease and basal cell carcinoma is recommended.


    Children under 18 years
    Hyperkeratotic actinic keratosis
    Morpheaform basal cell carcinoma

    Precautions and Warnings

    Discontinue UV therapy before starting treatment
    Contains arachis (peanut oil), soya or soya derivative
    Contains hydroxybenzoate
    Avoid contact with eyes
    Staff & patients: Protective goggles for the lamp spectrum used to be worn
    Treatment to be administered by or under supervision of specialist
    Discontinue immediately if amnesia occurs
    Some ingredients may cause sensitisation
    Breastfeeding: Do not breastfeed & discard milk for 48 hours after therapy
    Advise patient to avoid sunbathing for 24hrs prior + 48hrs post treatment
    Fire hazard: Keep away from naked flames and potential sources of ignition

    There is no experience of treating pigmented or highly infiltrating lesions or lesions located on the genitalia with methyl aminolevulinate cream. There is also no experience with treating lesions greater than 40 mm. Larger lesions (more than 20 mm in diameter) typically show lower response rates than those of smaller lesions. There is little experience with treating Bowen's disease in patients receiving immunosuppressive medication and none in patients with a history of arsenic exposure. A study conducted in immunocompromised organ transplant patients did not identify safety concerns other than those seen in immunocompetent patients.

    The excipient cetostearyl may cause local skin reactions, for example, allergic contact dermatitis.

    Pregnancy and Lactation


    Methyl aminolevulinate is contraindicated during pregnancy.

    The manufacturer does not recommend using methyl aminolevulinate during pregnancy and in women of child bearing potential not using contraception. Animal studies show reproductive toxicity. At the time of writing there is limited human data available. Risks are unknown.


    Methyl aminolevulinate is contraindicated during breastfeeding.

    The manufacturer advises discontinuing breastfeeding or discontinuing methyl aminolevulinate. The amount of active ingredient excreted into breast milk is unknown and a risk to the infant cannot be excluded.

    Side Effects

    Allergic contact dermatitis
    Amnesia (transient)
    Application site reaction
    Burning sensation (local)
    Crusting of skin
    Eye pain
    Eye swelling
    Eyelid oedema
    Facial oedema
    Localised exfoliation
    Pustular rash
    Sensation of warmth
    Skin infection
    Skin ulcer
    Wound haemorrhage


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: May 2014

    Reference Sources

    Summary of Product Characteristics: Metvix 160mg/g cream. Galderma (U.K.) Ltd. Revised October 2019.

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