Methyl aminolevulinate cream 16%
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Cream containing methyl aminolevulinate (as hydrochloride).
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.
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
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.
Allergic contact dermatitis
Application site reaction
Burning sensation (local)
Crusting of skin
Sensation of warmth
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: May 2014
Summary of Product Characteristics: Metvix 160mg/g cream. Galderma (U.K.) Ltd. Revised October 2019.
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