Fludeoxyglucose F 18
(Fludeoxyglucose F-18)Fludeoxyglucose F 18 Prescribing Information
Warnings and Precautions: (
Radiation-emitting products, including Fludeoxyglucose F 18 Injection USP, 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 [
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 USP administration.
7/2010
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 .
To report SUSPECTED ADVERSE REACTIONS, contact The Feinstein Institute for Medical Research at 516-562-1042 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
7/2010
Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F 18 Injection USP 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 |
| Positron(β+) | 96.73 | 249.8 keV |
| Gamma(±)* | 193.46 | 511.0 keV |
*Produced by positron annihilation
From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981)
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). 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 |
| 0* | 1.000 |
| 15 | 0.909 |
| 30 | 0.826 |
| 60 | 0.683 |
| 110 | 0.500 |
| 220 | 0.250 |
*calibration time
Multiple-dose glass vial containing 0.74 – 8.88 GBq (20 - 240 mCi/mL) of Fludeoxyglucose F 18 Injection USP and 4.5 mg of sodium chloride in citrate buffer (approximately 29 mL volume) for intravenous administration. Ethanol (3 mg/mL) is used as an antioxidant in Fludeoxyglucose F 18 Injection USP. The pH of the solution is between 4.5 and 7.5.
- Pregnancy Category C: No human or animal data. Consider alternative diagnostics; use only if clearly needed ().8.1 PregnancyPregnancy Category C
Animal reproduction studies have not been conducted with Fludeoxyglucose F 18 Injection USP. It is also not known whether Fludeoxyglucose F 18 Injection USP 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 USP 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 USP is administered to a woman who is breast-feeding ().8.3 Nursing Mothers
It is not known whether Fludeoxyglucose F 18 Injection USP 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 USP 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 Use
The 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 USP have not been established in pediatric patients.
None