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Quick facts
- Drug class
- Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
- How it is given
- intravenous
- Type
- human prescription drug
We do not publish dosing. How much of this medicine to take, how often, and for how long depends on your age, weight, kidney and liver function, other conditions and other medicines. That is a decision for the person who prescribes or dispenses it. Follow the directions on your own pack and ask your pharmacist if anything is unclear.
What it is used to treat
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 ). • 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 ( 1 ). • Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures ( 1 ). 1.1 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. 1.2 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. 1.3 Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
About this medicine
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 181.26, and has the following chemical structure: Fludeoxyglucose F-18 Injection is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.74 - 18.5 GBq (20 - 500 mCi/mL) of 2-deoxy-2-[ 18 F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative. Chemical Structure 11.2 Physical Characteristics Fluorine F-18 has a physical half-life of 109.7 minutes and decays to Oxygen O-18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV “annihilation” gamma photons that are produced and emitted simultaneously in opposite directions when the positron interacts with an electron (Table 2). Table 2. Principal Radiation Emission Data for Fluorine F-18 Radiation/Emission % Per Disintegration Mean Energy * Produced by positron annihilation From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981) Positron(β+) 96.73 249.8 keV Gamma(±)* 193.46 511.0 keV The specific gamma ray constant (point source air kerma coefficient) for fluorine F-18 is 5.7 R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb) or 2.9 mm tungsten (W) alloy. The range of attenuation coefficients for this radionuclide as a function of shield thickness is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb or 5.8 mm thickness of W alloy, with a coefficient of attenuation of 0.25, will decrease the external radiation by 75%. Table 3. […]
How it works
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. When allowance is made for the kinetic differences between glucose and Fludeoxyglucose F-18 transport and phosphorylation (expressed as the ''lumped constant'' ratio), Fludeoxyglucose F-18 is used to assess glucose metabolism. In comparison to background activity of the specific organ or tissue type, regions of decreased or absent uptake of Fludeoxyglucose F-18 reflect the decrease or absence of glucose metabolism. Regions of increased uptake of Fludeoxyglucose F-18 reflect greater than normal rates of glucose metabolism.
Warnings and cautions
• 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 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.
Reported side effects
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 with other medicines
The possibility of interactions of Fludeoxyglucose F-18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.
Use in specific groups
• Pregnancy Category C: No human or animal data. Consider alternative diagnostics; use only if clearly needed ( 8.1 ). • Nursing mothers: Use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if Fludeoxyglucose F-18 Injection is administered to a woman who is breast-feeding ( 8.3 ). • Pediatric Use: Safety and effectiveness in pediatric patients have not been established in the oncology and cardiology settings ( 8.4 ). 8.1 Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Fludeoxyglucose F-18 Injection. It is also not known whether Fludeoxyglucose F-18 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Consider alternative diagnostic tests in a pregnant woman; administer Fludeoxyglucose F-18 Injection only if clearly needed. 8.3 Nursing Mothers It is not known whether Fludeoxyglucose F-18 Injection is excreted in human milk. Consider alternative diagnostic tests in women who are breast-feeding. Use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if Fludeoxyglucose F-18 Injection is administered to a woman who is breast-feeding. 8.4 Pediatric Use The safety and effectiveness of Fludeoxyglucose F-18 Injection in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined. In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F-18 Injection have not been established in pediatric patients.
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This page is built from the openFDA record of the U.S. Food and Drug Administration's approved labelling for this product, effective 4 December 2020. Label text has been shortened and reformatted for readability; safety wording has not been altered in meaning. FDA labelling describes products approved in the United States — brand names, strengths, formulations and approved uses may differ in your country. Always read the leaflet that comes with your own pack. PocketsInfo is not affiliated with, and is not endorsed by, the FDA. Retrieved 2026-07-30.