GLEOLAN 1500 mg/1
AMINOLEVULINIC ACID HYDROCHLORIDE · POWDER, FOR SOLUTION · Medexus Pharma, Inc.
Gleolan is a prescription oral powder containing aminolevulinic acid hydrochloride used to help identify cancerous tissue during brain surgery. When taken before surgery, it causes cancer cells to fluoresce under special lighting, allowing surgeons to better visualize and remove tumor tissue.
Key Facts
- Brand Name
- GLEOLAN
- Generic Name
- AMINOLEVULINIC ACID HYDROCHLORIDE
- NDC Code (Product)
59137-231- Manufacturer
- Medexus Pharma, Inc.
- Strength
- 1500 mg/1
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA208630
- Marketing Start
- 04/14/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 & 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 con…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to the aminolevulinic acid (ALA) or porphyrins. [see Warnings and Precautions (5.3) ] Acute or chronic types of porphyria, due to potential ineffectiveness of the drug in these patients. Hypersensitivity to aminolevulinic acid (ALA) or porphyrins. ( 4 , 5.3 , 6.2 ) Acute or chronic types of porphyria. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Phototoxic Drugs Patients exposed to a photosensitizing agent may experience a phototoxic skin reaction (severe sunburn). Due to the risk of possible phototoxic reactions, avoid administering phototoxic drugs such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines, and topical preparations containing ALA for 24 hours before and after administration of Gleolan.
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions occurring in >1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting. ( 6.1 ) Adverse reactions occurring in < 1% of patients in the first 6 weeks after surgery were: chills, photosensitivity reaction, solar dermatitis, hypotension, abnormal liver function test, and diarrhea. ( 6.1 ) Neurologic events related to the surgical procedure occurred in 29% of patients and included: aphasia, hemiparesis, hemianopia, headache, seizure, hemiplegia, monoparesis, hypoesthesia, and brain edema. ( 6.1 ) Elevated liver enzymes occurred in clinical studies. There were no cases of liver failure. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact NXDC toll-free at (844) 517-5252 and adverseevents@nxdevcorp.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Gleolan is supported by data from 5 open label clinical stu…
Frequently Asked Questions
What is GLEOLAN used for?
Gleolan is a prescription oral powder containing aminolevulinic acid hydrochloride used to help identify cancerous tissue during brain surgery. When taken before surgery, it causes cancer cells to fluoresce under special lighting, allowing surgeons to better visualize and remove tumor tissue.
Is GLEOLAN a controlled substance?
GLEOLAN is not classified as a controlled substance by the DEA.
What is the generic name for GLEOLAN?
The generic name for GLEOLAN is AMINOLEVULINIC ACID HYDROCHLORIDE. There are 2 other brand versions of AMINOLEVULINIC ACID HYDROCHLORIDE.
What is the NDC code for GLEOLAN 1500 mg/1?
The NDC (National Drug Code) for GLEOLAN 1500 mg/1 is 59137-231, listed by Medexus Pharma, Inc..