Fludeoxyglucose f-18

Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

F 18 Fludeoxyglucose is a glucose analog that concentrates in cells that rely upon glucose as an energy source, or in cells whose dependence on glucose increases under pathophysiological conditions. Fludeoxyglucose F 18 is transported through the cell membrane by facilitative glucose transporter proteins and is phosphorylated within the cell to [F 18] FDG-6-phosphate by the enzyme hexokinase. Once phosphorylated it cannot exit until it is dephosphorylated by glucose-6-phosphatase. Therefore, within a given tissue or pathophysiological process, the retention and clearance of Fludeoxyglucose F 18 reflect a balance involving glucose transporter, hexokinase and glucose-6-phosphatase activities. Fludeoxyglucose F 18 is used to assess glucose metabolism.

Fludeoxyglucose F 18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient. Screen for blood glucose abnormalities. In the oncology and neurology settings, instruct patients to fast for 4 – 6 hours prior to the drug’s injection. Consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to the drug’s administration. In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to the drug’s injection facilitates localization of cardiac ischemia. Aseptically withdraw Fludeoxyglucose F 18 Injection from its container and administer by intravenous injection.

None None

Radiation risks: use smallest dose necessary for imaging. Blood glucose abnormalities: may cause suboptimal imaging. 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. Blood Glucose Abnormalities In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose F 18 Injection administration.

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.

The interaction of Fludeoxyglucose F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

Store the Fludeoxyglucose F 18 Injection vial upright in a lead shielded container at 25°C (77°F), excursions permitted to 15º to 30°C (59º to 86°F). Store and dispose of Fludeoxyglucose F 18 Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State.