Overview
11 DESCRIPTION 11.1 Chemical Characteristics Fludeoxyglucose F-18 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[ 18 F]fluoro-D-glucose has the molecular formula of C 6 H 11 18 FO 5 with a molecular weight of 181.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Fludeoxyglucose F-18 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 [ 18 F] 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.
Indications
- 1 INDICATIONS AND USAGE 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 ( 1 ).
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION 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 [ see Description ( 11.2 ) ]. Fludeoxyglucose F-18 Injection emits radiation. Use procedures to minimize radiation exposure. Screen for blood glucose abnormalities.
Contraindications
- 4 CONTRAINDICATIONS None None ( 4 )
Side Effects
- 6 ADVERSE REACTIONS 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, contact Cardinal Health at 1-800-618-2768 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
- 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.