Gleolan

— THERAPEUTIC CATEGORIES —
  • Imaging agents

Gleolan Generic Name & Formulations

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