GLEOLAN

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. 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. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION For oral use only ( 2.1 ) Recommended reconstituted oral dose of Gleolan is 20 mg/kg. ( 2.1 ) Administer Gleolan to patient orally 3 hours (range 2 to 4 hours) before anesthesia. ( 2.1 ) See Full Prescribing Information for reconstitution information. ( 2.2 ) Use appropriate visualization techniques with appropriate surgical microscopes and light source filters. ( 2.4 ) 2.1 Recommended Dose For oral use only The recommended oral dose of reconstituted Gleolan is 20 mg / kg body weight. More than 1 vial may be required. 2.2 Reconstitution of Gleolan Gleolan powder must be reconstituted prior to administration by a healthcare provider according to the following instructions: Determine the total number of vials needed to achieve the intended dose for the patient according to the equation below (rounded up to the nearest whole vial): # of vials = Patient Body Weight (kg) 75 kg / vial Completely remove the white cap and aluminum crimp seal from each vial. Remove and retain the rubber stopper from the vial. Using an appropriate volumetric measuring device (e.g., flask, graduated cylinder, dosing syringe), measure 50 mL of drinking water and add to each vial containing 1,500 mg of Gleolan. Gently swirl the vial to completely dissolve the powder. The resulting reconstituted solution (30 mg of Gleolan per mL) is clear and colorless to slightly yellowish. If required, replace the stopper and store reconstituted solution for up to 24 hours at room temperature prior to administration. 2.3 Gleolan Administration Gleolan is for ORAL USE ONLY. The reconstituted Gleolan solution is administered according to the following steps: Calculate the administration volume, in mL, to achieve the intended dose according to the following equation: Administration Volume (mL) = Patient Body Weight (kg) * 20 mg/kg 30 mg/mL Transfer the entire contents of the prepared vial(s) into an appropriate dosing container (e.g., oral medicine bottle); ensure the entire contents of the vials are transferred. After transfer, discard the empty vial(s). Using a disposable volumetric syringe, remove the administration volume of reconstituted Gleolan solution from the dosing container and transfer to a separate oral dosing container. Discard unneeded volume of Gleolan solution. Administer orally 3 hours (range 2 to 4 hours) prior to induction of anesthesia. 2.4 Imaging Instructions Gleolan should be used with a standard surgical operating microscope adapted with a blue light emitting light source (power density 40-80 mW/cm 2 ) and ancillary excitation and emission filters to visualize fluorescence excitation in the wavelength of 375 to 440 nm and for observation from 620 to 710 nm. Filters transmit porphyrin fluorescence as red-violet, as well as a fraction of backscattered blue excitation light necessary for distinguishing nonfluorescing tissue. Gleolan should only be used by neurosurgeons who have completed a training program on use of fluorescence in surgery. Training is provided by the distributor. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Phototoxic reactions: Do not administer phototoxic drugs (St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period. Reduce exposure to sunlight or room lights for 48 hours after oral administration of Gleolan. ( 5.1 , 7 ) Risk of misinterpretation: Non-fluorescing tissue in the surgical field does not rule out the presence of tumor. ( 5.2 , 14 ) 5.1 Risk of Phototoxic Reaction Due to the risk of phototoxic reactions, do not administer phototoxic drugs (St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period [see Drug Interactions (7) ] . Reduce exposure to sunlight or room lights for 48 hours after administration of Gleolan. 5.2 Risk of Misinterpretation 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 [see Clinical Studies (14) ] . Fluorescence may be seen in areas of inflammation or metastases from other tumor types. 5.3 Hypersensitivity Reactions Hypersensitivity reactions, includ