Video demonstration shows how Gleolan works.
Gleolan is an optical imaging agent indicated in patients with glioma (World Health Organization suspected Grades III and IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.
Gleolan is a pro-drug, preferentially taken up by tumor cells and metabolized in the mitochondria to its fluorescent metabolite, Protoporphyrin IX (PpIX). PpIX is a key precursor in the heme biosynthesis pathway.
Upon illumination with blue light, wavelength of 375 to 440 nm, the PpIX in tumor tissue fluoresces with red-violet color that can be seen in the microscope with appropriate emission filters (620 to 710 nm), distinguishing it from non-fluorescing tissue, which appears blue.
ALA occurs endogenously as a metabolite that is formed in the mitochondria from succinyl-CoA and glycine. Exogenous administration of ALA leads to accumulation of the ALA metabolite PpIX in tumor cells. The reason for the accumulation of PpIX in neoplastic brain tissue is not known.
Gleolan is indicated in patients with high-grade glioma (World Health Organization suspected Grades III or IV).
Due to risk of possible photosensitizing reactions, avoid administering phototoxic drugs (St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines) and topical preparations containing ALA for 24 hours prior to Gleolan administration and 24 hours post-administration.
During procedural preparation, secure a dimly lit room for post-dosing care and reduce exposure from sunlight and room light for 48 hours after dosing.
Gleolan is weight-base dosed at 20 mg/kg. The effect of renal or hepatic impairment on the pharmacokinetics of ALA following Gleolan administration is unknown. Advise patients that they may experience elevated liver enzymes (ALT and GGT) within the first week after surgery. This elevation may persist after 6 weeks.
As noted in the Full Prescribing information, Gleolan should only be used by neurosurgeons who have completed a training program on the use of fluorescence in surgery. Click here to access the online training module.
During glioma surgery, Gleolan is used with a standard surgical operating microscope adapted with a blue light-emitting source and filters for excitation of light at wavelength 375 to 440 nm and observation at wavelengths of 620 to 710 nm. Please consult the Full Prescribing Information for more information on imaging instructions.
Gleolan is available on order for delivery to centers from which at least one neurosurgeon has successfully completed the Gleolan training program (provided by Medexus Pharma, Inc.) and is on the current Approved User List. The Approved User List is maintained, monitored, and updated by Medexus Pharma, Inc.. and used at your dispensing pharmacy allowing trained neurosurgeons to order Gleolan. The dispensing pharmacist must confirm that the requesting neurosurgeon is an Approved User prior to Gleolan being dispensed.
Please click here for more information on ordering or contact us directly at 1-833-GLEOLAN (1-833-453-6526).
Nabavi A, Thurm H, Zountsas B, et al. Five-aminolevulinic acid for fluorescence-guided resection of recurrent malignant gliomas: a phase II study. Neurosurgery. 2009;65(6):1070-1077.
Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen H-J. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. The Lancet Oncology. 2006;7(5):392-401.
Stummer W, Ullrich W, Pietsch, T. 5-Aminolevulinic Acid-derived Tumor Fluorescence: The Diagnostic Accuracy of Visible Fluorescence Qualities as Corroborated by Spectrometry and Histology of Postoperative Imaging. Neurosurgery. 2014;74(3):310-320.
Do not use Gleolan in patients with:
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 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.
See information under Warnings and Precautions regarding phototoxic reactions.
Please see Full Prescribing Information
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