Fludeoxyglucose F-18
Fludeoxyglucose F-18 Prescribing Information
Fludeoxyglucose F-18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:
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 [
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).
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 10-6Gy/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%.
Shield Thickness (Pb) mm | Shield Thickness (W) Alloy mm | Coefficient of Attenuation |
|---|---|---|
0 | 0 | 0.00 |
4 | 2.9 | 0.50 |
8 | 5.8 | 0.25 |
13 | 9.4 | 0.10 |
26 | 18.7 | 0.01 |
39 | 27.6 | 0.001 |
52 | 37.4 | 0.0001 |
For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.
Minutes | Fraction Remaining | ||||||
|---|---|---|---|---|---|---|---|
| * calibration time | |||||||
0* | 1.000 | ||||||
15 | 0.909 | ||||||
30 | 0.826 | ||||||
60 | 0.683 | ||||||
110 | 0.500 | ||||||
220 | 0.250 | ||||||
440 | 0.060 | ||||||
Multiple-dose glass vial containing 0.74 - 18.5 GBq (20 - 500 mCi/mL) of Fludeoxyglucose F-18 Injection and 4.5 mg of sodium chloride in citrate buffer (approximately 2 - 30 mL volume) for intravenous administration.
• Pregnancy Category C: No human or animal data. Consider alternative diagnostics; use only if clearly needed ().8.1 PregnancyPregnancy Category CAnimal 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.
• 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 Nursing MothersIt 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.
• Pediatric Use: Safety and effectiveness in pediatric patients have not been established in the oncology and cardiology settings ().8.4 Pediatric UseThe 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.
None
• Radiation risks: use smallest dose necessary for imaging ().5.1 Radiation RisksRadiation-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].• Blood glucose abnormalities: may cause suboptimal imaging ().5.2 Blood Glucose AbnormalitiesIn 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.