Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 studies, which included 527 patients with glioma who received ALA HCl.
Adverse reactions that occurred in > 1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting.
Adverse reactions occurring in the first 6 weeks after surgery in < 1% of patients were: chills, photosensitivity reaction, solar dermatitis, hypotension, abnormal liver function test, and diarrhea.
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.
Like all medications, Gleolan can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: