Fludeoxyglucose F18
(Fludeoxyglucose F-18)Fludeoxyglucose F18 Prescribing Information
Fludeoxyglucose F 18 Injection USP 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 109.8 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 .
| Radiation/Emission | %Per Disintegration | Mean Energy |
|---|---|---|
| From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981) | ||
| Positron (β+) | 96.73 | 249.8 keV |
| Gamma (±)Produced by positron annihilation | 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 × 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb, with a coefficient of attenuation of 0.25, will decrease the external radiation by 75%.
| Shield thickness (Pb) mm | Coefficient of attenuation |
|---|---|
| 0 | 0.00 |
| 4 | 0.50 |
| 8 | 0.25 |
| 13 | 0.10 |
| 26 | 0.01 |
| 39 | 0.001 |
| 52 | 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 |
|---|---|
| 0calibration time | 1.000 |
| 15 | 0.909 |
| 30 | 0.826 |
| 60 | 0.683 |
| 110 | 0.500 |
| 220 | 0.250 |
Multiple-dose glass vial containing 0.74 to 11.1 GBq (20 mCi/mL to 300 mCi/mL) of Fludeoxyglucose F 18 Injection and 4.5 mg/mL of sodium chloride in citrate buffer (approximately 14 to 30 mL volume) for intravenous administration.
- Lactation: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 9 hours after Fludeoxyglucose F 18 Injection ().
8.2 LactationRisk SummaryA published case report and case series show the presence of Fludeoxyglucose F 18 Injection in human milk following administration. There are no data on the effects of Fludeoxyglucose F 18 Injection on the breastfed infant or the effects on milk production. Exposure of Fludeoxyglucose F 18 Injection to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (
see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fludeoxyglucose F 18 Injection, any potential adverse effects on the breastfed child from Fludeoxyglucose F 18 Injection or from the underlying maternal condition.Clinical ConsiderationsTo decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breastmilk and avoid close (breast) contact with the infant for at least 9 hours after the administration of Fludeoxyglucose F 18 Injection.
- 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 USP 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 (2.5)]. - 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.