Dosage & Administration

Dosage

The recommended reconstituted oral dose of Gleolan is 20 mg/kg.

Reconstitution of Gleolan

Gleolan powder must be reconstituted prior to oral administration by a healthcare provider according to the following instructions:

Determine the total number of vials needed to achieve the intended dose for the patient according to the equation below (rounded up to the nearest whole vial). More than one vial may be required
Using an appropriate volumetric measuring device (eg flask, graduated cylinder, dosing syringe), measure 50 mL of drinking water and add to each vial containing 1,500 mg of Gleolan
For oral solution: 1,500 mg ALA HCl lyophilized powder, equivalent to 1,170 mg ALA per vial. The reconstituted ALA HCl solution contains 30 mg per mL and is clear and colorless to slightly yellowish in color

Determine the total number of vials needed to achieve the intended dose for the patient according to the equation below (rounded up to the nearest whole vial):

Important Safety Information

Contraindications

Do not use Gleolan in patients with:

hypersensitivity to aminolevulinic acid (ALA) or porphyrins

acute or chronic types of porphyria

Warnings and Precautions

Due to the risk of phototoxic reactions, do not administer phototoxic drugs and topical preparations containing ALA for 24 hours during the perioperative period. Reduce exposure to sunlight or room lights for 48 hours after administration of Gleolan.

Errors may occur with the use of Gleolan for intraoperative visualization of malignant glioma, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of tumor in patients with glioma. Fluorescence may be seen in areas of inflammation or metastases from other tumor types.

Hypersensitivity reactions, including serious hypersensitivity reactions have occurred; these reactions include anaphylactic shock, swelling, and urticaria. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions.

Adverse Reactions

Adverse reactions occurring in >1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting.

Nervous system disorders occurred in 29% of patients within the first week after surgery and events occurring in >1% of patients included: aphasia (8%), hemiparesis (7.8%), hemianopsia (3.2%), headache (2.7%), seizure (1.9%), hemiplegia (1.9%), monoparesis (1.3%) and hypoesthesia (1.1%). Brain edema occurred in <1% of patients in the first 6 weeks after surgery. In a randomized clinical trial, the numbers of serious neurologic adverse events in the post operative period were higher in patients randomized to ALA fluorescence arm compared to the control arm. An imbalance was notable for the adverse events aphasia, ataxia, convulsion and hemianopsia and is likely related to the higher amount of brain resection performed in the ALA arm. At longer follow up periods, the numbers between the two arms appeared similar.

Worsening of >2 Common Toxicity Criteria grades in alanine aminotransferase and gamma-glutamyl transferase occurred in 15.8% and 11.6% of patients, respectively, within the first week after surgery. Absolute levels ranged from 2 times to greater than 10 times the upper limit of normal for each parameter. At 6 weeks, these measurements remained elevated in 2.9% and 7.5% of patients, respectively. There were no cases of liver failure.

Drug-Drug Interactions

See information under Warnings and Precautions regarding phototoxic reactions.