Healthcare Professional Resources
Available Gleolan resources:
Q: What is the indicated use of Gleolan?
Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.
Q: How does Gleolan work?
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 which can be seen in the microscope with appropriate emission filters (620 to 710 nm) distinguishing it from non-fluorescing tissue which appears blue.
Q: What is the mechanism of action?
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.
Q: Can Gleolan be used in all brain tumor cases?
Gleolan is indicated in patients with high grade glioma (suspected World Health Organization Grades III or IV).
Q: What drugs potentially interact with Gleolan?
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.
Q: What are the unique precautions appropriate for the use of Gleolan?
During procedural preparation, secure a dim-light room for post dosing care and reduce exposure from sunlight and room light for 48 hours after dosing.
Q: Do I need to adjust the dose of Gleolan in patients with renal or hepatic dysfunction?
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.
Q: How do I get trained?
As noted in the Full Prescribing information, Gleolan should only be used by neurosurgeons who have completed a training program on use of fluorescence in surgery. Click here to access the online training module.
Q: What equipment /microscope do I need to use Gleolan?
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.
Q: How can I order Gleolan for my hospital center?
Gleolan is available on order for delivery to centers from which at least one neurosurgeon has successfully completed the Gleolan training program (provided by NX Development Corp.) and is on the current Approved User List. The Approved User List is maintained, monitored and updated by NX Development Corp. 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.
Gleolan is available through our sole distributor, LifeScience Logistics. Please click here for more information on ordering or contact LSL directly at 1-833-471-3404.
Fluorescence Observed in Malignant Glioma
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.
Center Orientation: We are going to launch without that for now