Fludeoxyglucose F18 (Page 2 of 4)

2.7 Imaging Guidelines

• Initiate imaging within 40 minutes following Fludeoxyglucose F18 Injection USP administration.
• Acquire static emission images 30 – 100 minutes from the time of injection.

3. Dosage Forms and Strengths

Multiple-dose glass vial containing 0.74 — 11.1GBq (20 — 300 mCi/mL) of Fludeoxyglucose F18 Injection USP and 4.5 mg/mL sodium chloride in citrate buffer (approximately 25 — 30 mL volume) for intravenous administration.

4. Contraindications

None

5. Warnings and Precautions

5.1 Radiation Risks

Radiation-emitting products, including Fludeoxyglucose F18 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[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 F18 Injection USP administration.

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.

7. Drug Interactions

The interaction of Fludeoxyglucose F18 Injection USP with other drugs taken by patients undergoing PET imaging has not been studied.

8. Use in Specific Populations

8.1 Pregnancy

Risk Summary

Data from published case series and case reports describe Fludeoxyglucose F 18 Injection USP crossing the placenta with uptake by the fetus (see Data). All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. However, published studies that describe Fludeoxyglucose F 18 Injection USP use in pregnant women have not identified a risk of drug-associated major birth defects, miscarriage, or adverse maternal or fetal outcomes. If considering Fludeoxyglucose F 18 Injection USP administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Fludeoxyglucose F 18 Injection USP and the gestational timing of exposure.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

Data

Human Data

Data from published case series and case reports describe Fludeoxyglucose F 18 Injection USP crossing the placental barrier and visualization of radioactivity throughout the body of the fetus. The estimated fetal absorbed radiation dose from the maximum labeled dose (370 MBq) of Fludeoxyglucose F 18 was 10mGy with first trimester exposure to PET alone and 20mGy with first trimester exposure to PET/CT scan combination. Long-term adverse radiation effects to a child exposed to Fludeoyxglucose F 18 Injection in utero are unknown. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50mGy, which represents less than 20mGy fetal doses.

8.2 Lactation

Risk Summary

A published case report and case series show the presence of Fludeoxyglucose F 18 Injection USP in human milk following administration. There are no data on the effects of Fludeoxyglucose F 18 Injection USP on the breastfed infant or the effects on milk production. Exposure of Fludeoxyglucose F 18 Injection USP 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 USP, any potential adverse effects on the breastfed child from Fludeoxyglucose F 18 Injection USPor from the underlying maternal condition.

Clinical Considerations

To 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 USP.

8.4 Pediatric Use

The safety and effectiveness of Fludeoxyglucose F18 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 F18 Injection USP have not been established in pediatric patients.

11. Description

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 direction 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
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 ^-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%.

Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) shielding

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.

Table 4. Physical Decay Chart for Fluorine F 18

Minutes	Fraction Remaining
0*	1.000
15	0.909
30	0.826
60	0.683
110	0.500
220	0.250

*calibration time

11.1 Chemical Characteristics

Fludeoxyglucose F18 Injection USP 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 H11 18FO5 with a molecular weight of 181.26, and has the following chemical structure:

Fludeoxyglucose F18 Injection USP is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 11.1GBq (20.0-300 mCi) of 2-deoxy-2-[ 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.