methyl aminolevulinate hydrochloride: clinical use

Prescribing considerations

• Restricted to adults; paediatric safety and efficacy are not established.
• Confirm that lesion type, thickness, pigmentation, infiltration and anatomical site fit the licensed indication.
• Natural or artificial daylight activation applies to actinic keratosis; basal cell carcinoma and Bowen’s disease require the appropriate red-light approach.
• Use requires personnel trained in photodynamic therapy and compatible, appropriately maintained light equipment.
• Avoid direct ocular exposure and application to eyelids or mucous membranes.

Contraindications and cautions

• Hypersensitivity to methyl aminolevulinate or any excipient, including arachis oil; peanut or soya allergy
• Morpheaform basal cell carcinoma
• Porphyria

Monitoring

• Assess lesion response clinically and investigate persistent or suspicious lesions appropriately.
• Check blood pressure before red-light treatment and again if severe illumination pain occurs.
• Stop red-light photodynamic therapy immediately if confusion or disorientation develops.
• Monitor immunosuppressed transplant recipients closely because clinical experience is limited.
• Watch for contact sensitisation, angioedema, infection and unexpectedly severe local phototoxicity.

Clinical pharmacology

Topical methyl aminolevulinate is converted to intracellular photoactive porphyrins. Light activation generates singlet oxygen and local phototoxic damage; systemic dermal absorption through intact human skin is low in vitro.

Formulation and product differences

• The selected product is a cream that is cream to pale yellow and requires refrigerated storage.
• It contains arachis oil and refined almond oil; cetostearyl alcohol and parabens may cause local or delayed allergic reactions.
• Do not use cream showing visible deterioration, such as darkening towards brown.

Cream

Route: Cutaneous

Strengths: 160 mg/g