Gleolan Generic Name & Formulations
Legal Class
Rx
General Description
Aminolevulinic acid (ALA) HCl 1500mg; lyophilized pwd for oral soln after reconstitution.
Pharmacological Class
Optical imaging agent.
How Supplied
Pwd—50mL
Manufacturer
Generic Availability
NO
Gleolan Indications
Indications
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
Adult
See full labeling. Administer 20mg/kg orally 3hrs (range 2–4hrs) prior to anesthesia.
Children
Not established.
Gleolan Contraindications
Contraindications
Porphyrin hypersensitivity. Acute or chronic porphyria.
Gleolan Boxed Warnings
Not Applicable
Gleolan Warnings/Precautions
Warnings/Precautions
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.
Gleolan Pharmacokinetics
See Literature
Gleolan Interactions
Interactions
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
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
See Literature
Gleolan Note
Not Applicable
Gleolan Patient Counseling
See Literature