Aminolevulinic Acid Hydrochloride (3 brand names, 3 dosage forms, 2 routes)
Available dosage forms: GEL, SOLUTION, FOR SOLUTION.
Routes of administration: TOPICAL, ORAL.
Brand Names
- AMELUZ
- GLEOLAN
- LEVULAN
Related Health Topics
Related Conditions
Indications and Usage
Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery.
Contraindications
Hypersensitivity to the aminolevulinic acid (ALA) or porphyrins. [see Warnings and Precautions (5.3)] Acute or chronic types of porphyria, due to potential ineffectiveness of the drug in these patients.
Drug Interactions
Phototoxic Drugs Patients exposed to a photosensitizing agent may experience a phototoxic skin reaction (severe sunburn). Due to the risk of possible phototoxic reactions, avoid administering phototoxic drugs such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines, and topical preparations containing ALA for 24 hours before and after administration of Gleolan.
Mechanism of Action
ALA occurs endogenously as a metabolite that is formed in the mitochondria from succinyl-CoA and glycine. Exogenous administration of ALA leads to accumulation of the ALA metabolite PpIX in tumor cells. The reason for the accumulation of PpIX in neoplastic brain tissue is not known. During glioma surgery, Gleolan is used with an operating microscope adapted with a blue emitting light source (power density 40-80 mW/cm2) and filters for excitation light of wavelength 375 to 440 nm, and observation at wavelengths of 620 to 710 nm. This allows tumor tissue to be visualized as red fluorescence. Tissue lacking sufficient PpIX concentrations appears blue.
Overdosage
Overdosage has been associated with respiratory insufficiency and erythema. In the event of overdose, supportive measures should be provided as necessary, including protection from strong light sources.