Methyl Aminolevulinate

Registered South African indications:

• Actinic keratoses
• Basal cell carcinoma
• Squamous cell carcinoma in situ

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to arachis oil or peanut or soya
• Morpheaform basal cell carcinoma
• Porphyria

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Exposure to sunlight and ultraviolet light
• Thick (hyperkeratotic) actinic keratoses 
• Lesions which are pigmented, highly infiltrating or located on the genitalia
• Bowen´s disease lesions > 40mm
• Bowen´s disease in transplant patients on immunosuppressive therapy or in patients with a history of arsenic exposure
• Contact with eyes, eyelids or mucous membranes

Forms avail. in SA and covered in this monograph: cre

Used for the treatment of

Thin or non-hyperkeratotic and non-pigmented actinic keratoses
- On the face and scalp when other therapies are considered less appropriate
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
Squamous cell carcinoma in situ (Bowen’s disease) 
- When surgical excision is considered less appropriate

Consult specialist for dosages and regimens

Not established for use in children below 18 years

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Caution; not recommended

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly            

• No dose adjustment recommended

Central Nervous System Disorders

• Paraesthesia
• Headache
• Fatigue

Cardiovascular Disorders

• Wound haemorrhage
• Hypertension

Gastrointestinal Disorders

• Nausea

Skin and Subcutaneous Tissue Disorders

• Skin pain
• Skin burning sensation
• Scab
• Erythema
• Skin infection
• Skin ulcer
• Skin oedema
• Skin swelling
• Blister
• Skin hemorrhage
• Pruritus
• Skin exfoliation
• Skin warm
• Urticaria
• Rash
• Skin irritation
• Photosensitivity reaction
• Skin hypopigmentation
• Skin hyperpigmentation
• Heat rash
• Skin discomfort
• Angioedema
• Face oedema 
• Application site eczema
• Allergic contact dermatitis
• Pustular rash
• Application site discharge

Immune, Blood and Lymphatic System Disorders

• Feeling hot

Sensory Disorders

• Eye swelling
• Eye pain
• Eyelid oedema

No information available

None routine

After topical application of methyl aminolevulinate, porphyrins will accumulate intracellularly in the treated skin lesions. The intracellular porphyrins are photoactive, fluorescing compounds and, upon light activation in the presence of oxygen, singlet oxygen is formed which causes damage to cellular compartments, in particular the mitochondria. Light activation of accumulated porphyrins leads to a photochemical reaction and thereby phototoxicity to the light-exposed target cells.

Cream (per g) 160mg

• Metvix (Galderma) originator