Gleolan Generic Name & Formulations
Aminolevulinic acid (ALA) HCl 1500mg; lyophilized pwd for oral soln after reconstitution.
Optical imaging agent.
As an adjunct for the visualization of malignant tissue during surgery in patients with glioma (suspected WHO Grades III or IV on pre-op imaging).
Gleolan Dosage and Administration
See full labeling. Administer 20mg/kg orally 3hrs (range 2–4hrs) prior to anesthesia.
Porphyrin hypersensitivity. Acute or chronic porphyria.
Gleolan Boxed Warnings
Should only be used by trained neurosurgeons. Reduce exposure to sunlight or room lights for 48hrs after administration. Risk of misinterpretation (including false [–] and [+]). Have CPR equipment and personnel available to manage hypersensitivity reactions; monitor. Renal and hepatic impairment. Pregnancy. Nursing mothers: pump and discard breast milk for 24hrs after dose.
Risk of phototoxic reactions with phototoxic drugs (eg, St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones, tetracyclines, ALA-containing topical preps); avoid for 24hrs before and after Gleolan.
Gleolan Adverse Reactions
Pyrexia, hypotension, nausea, vomiting, chills, photosensitivity reaction, solar dermatitis, abnormal LFTs, diarrhea, neurologic events (eg, aphasia, hemiparesis, hemianopia, headache, seizure, hemiplegia, monoparesis, hypoesthesia), brain edema, elevated liver enzymes.
Gleolan Clinical Trials
Gleolan Patient Counseling