Gliolan

What it is

Gliolan is aminolevulinic acid hydrochloride powder for oral solution containing 30 mg/mL. Gliolan is supplied in a vial as a powder for oral solution. Aminolevulinic acid (ALA) is a natural biochemical precursor of heme that is metabolised to fluorescent porphyrins, particularly protoporphyrin IX (PPIX). Administration of excess exogenous ALA avoids negative feedback control and accumulation of PPIX occurs in target tissue. In the presence of visible light, fluorescence of PPIX in certain target tissues can be used for photodynamic diagnosis.

Approved indications

— Visualisation of malignant tissue during surgery for malignant gliomas that are glioblastoma multiforme on preoperative imaging in adult patients intended for resection of the tumour.

Dosing overview

The recommended dose is 20 mg aminolevulinic acid hydrochloride per kilogram body weight. The solution should be administered orally three hours (range 2–4 hours) before anaesthesia.

Key safety warnings

ALA-induced fluorescence of brain tissue does not provide information about the tissue's underlying neurological function. Therefore, resection of fluorescing tissue should be weighed up carefully against the neurological function of fluorescing tissue. Special care must be taken in patients with a tumour in the immediate vicinity of an important neurological function and pre-existing focal deficits (such as aphasia, vision disturbances and paresis) that do not improve on corticosteroid treatment. Fluorescence-guided resection in these patients has been found to impose a higher risk of critical neurological deficits. False negative and false positive results may occur with the use of 5-ALA for intraoperative visualisation of malignant glioma. Non-fluorescing tissue in the surgical field does not rule out the presence of tumour in patients with glioma. Fluorescence may be seen in areas of abnormal brain tissue (such as reactive astrocytes, atypical cells), necrotic tissue, inflammation, infections (such as fungal or bacterial infections and abscesses), CNS lymphoma or metastases from other tumour types. After administration of Gliolan, exposure of eyes and skin to strong light sources (such as operating illumination, direct sunlight or brightly focused indoor light) should be avoided for 24 hours. In patients with pre-existing cardiovascular disease, Gliolan should be used with caution since literature reports have shown decreased systolic and diastolic blood pressures, pulmonary artery systolic and diastolic pressure as well as pulmonary vascular resistance.

Contraindications

Gliolan is contraindicated in patients with hypersensitivity to ALA or porphyrins or to any of the excipients, acute or chronic types of porphyria, and in pregnancy.

Regulatory history

Gliolan was approved for registration on 31 October 2013, with initial registration on the ARTG occurring on 7 November 2013. The product is registered on the ARTG as aminolevulinic acid HCl powder for oral solution 30 mg/mL in vial formulation under licence category RE.