5-aminolevulinic acid hydrochloride topical
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Gel containing 5-aminolevulinic acid (as hydrochloride).
Treatment of actinic keratoses in combination with photodynamic therapy
Treatment of nodular basal cell carcinoma (other treatment unsuitable)
Treatment of superficial basal cell carcinoma (other treatment unsuitable)
Treatment of mild to moderate actinic keratoses and of field cancerization.
Treatment of basal cell carcinoma (BCC), superficial and/or nodular, when surgical treatment is unsuitable.
To be applied before photodynamic therapy.
Before applying, remove scales and crusts. If an epidermal keratin layer is covering nodular basal cell carcinoma lesions it should also be removed as well as any tumour material exposed. Lesion surfaces should be roughened gently. Care should be taken to avoid bleeding. Carefully wipe off lesions with an ethanol or isopropanol soaked cotton pad to degrease the skin.
Application of an occlusive dressing and incubation are required before red-light photodynamic therapy. No dressing is required before daylight photodynamic therapy.
Photodynamic therapy should be employed in accordance with manufacturer's information and local protocol.
Apply gel to cover the lesions or entire fields with cancerization of about 20cm squared and approximately 5mm of the surrounding area with a film of about 1mm thickness.
Actinic keratoses (AK) of the face or scalp: One session of photodynamic therapy (with daylight or red-light lamp).
Actinic keratoses (AK) in the body region trunk, neck or extremities: One session of narrow spectrum red-light photodynamic therapy.
Basal cell carcinoma (BCC): Two sessions of photodynamic therapy (with red-light lamp) one week apart.
Children under 18 years
Hypersensitivity to soya or soya derivative
Precautions and Warnings
Avoid concurrent use of immunosuppressants
Discontinue UV therapy before starting treatment
No experience if area to be treated affected by skin disease or tattoos
Treatment to be initiated and supervised by a specialist
Contains propylene glycol: may cause irritation
Contains sodium benzoate - mildly irritant to eyes, skin & mucous membranes
Contains soya or soya derivative
Avoid concurrent use of photosensitising agents
Avoid contact with ears
Avoid contact with mucous membranes
Avoid contact with nostrils or mouth
Avoid use in or near eyes
Avoid use on bleeding lesions
If accidental contact with eyes or mucous membranes - rinse with cool water
Staff & patients: Protective goggles for the lamp spectrum used to be worn
Discontinue immediately if amnesia occurs
Evaluate the patient 3 months after treatment
Monitor basal cell carcinoma closely long term
Amnesia may occur
Hypersensitivity may occur before or after illumination
Advise patient not to take St John's wort concurrently
Breastfeeding: Do not breastfeed & discard milk for 12 hours after therapy
Advise patient on appropriate sun protection methods
Avoid sun exposure for 48 hours after treatment
Pregnancy and Lactation
Use 5-aminolevulinic with caution during pregnancy.
The manufacturer recommends 5-aminolevulinic acid is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Animal studies do not indicate direct/indirect harmful effects regarding reproductive toxicity. At the time of writing there is limited human data available. Risks are unknown.
Use 5-aminolevulinic with caution during breastfeeding.
The manufacturer notes that it is unknown whether 5-aminolevulinic acid/metabolites are excreted in human milk. A risk to the breast-fed infant cannot be excluded and breast-feeding should be discontinued for 12 hours after treatment with 5-aminolevulinic acid.
Crusting of skin
Discharge (application site)
Erythema at application site
Inflammation (application site)
Oedema at application site
Pain at application site
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: August 2019
Summary of Product Characteristics: Ameluz 78mg/g gel. Biofrontera Pharma GmbH. Revised March 2020.
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