FLUDEOXYGLUCOSE F18

Distribution: In four healthy male volunteers, receiving an intravenous administration of 30 seconds in duration, the arterial blood level profile for Fludeoxyglucose F 18 decayed triexponentially. The effective half-life ranges of the three phases were 0.2-0.3 minutes, 10-13 minutes with a mean and standard deviation (STD) of 11.6 (±) 1.1 min, and 80-95 minutes with a mean and STD of 88 (±) 4 min. Plasma protein binding of Fludeoxyglucose F 18 has not been studied. Metabolism: Fludeoxyglucose F...

14.1 Oncology The efficacy of Fludeoxyglucose F 18 Injection in positron emission tomography cancer imaging was demonstrated in 16 independent studies. These studies prospectively evaluated the use of Fludeoxyglucose F 18 in patients with suspected or known malignancies, including non-small cell lung cancer, colo-rectal, pancreatic, breast, thyroid, melanoma, Hodgkin's and non-Hodgkin's lymphoma, and various types of metastatic cancers to lung, liver, bone, and axillary nodes. All these studies had at least 50 patients and used pathology as a standard of truth. The Fludeoxyglucose F 18 Injecti...

Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available. Hypersensitivity reactions have occurred; have emergency resuscitation equipment and personnel immediately available (6) . To report SUSPECTED ADVERSE REACTIONS, MIPS Cyclotron & Radiochemistry Facility at 650-725-4182 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Radiation risks: use smallest dose necessary for imaging (5.1) . Blood glucose abnormalities: may cause suboptimal imaging (5.2) . 5.1 Radiation Risks Radiation-emitting products, including Fludeoxyglucose F 18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker[see Dosage and Administration (2.5) ]. 5.2 Blood Glucose Abnormalities In the oncology and neu...

7 DRUG INTERACTIONS The possibility of interactions of Fludeoxyglucose F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.