Fludeoxyglucose F-18 (Page 2 of 4)

2.5 Radiation Safety – Drug Handling

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Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Fludeoxyglucose F-18 Injection to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel and other persons.

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Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

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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 [see Description (11.2) ].

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The dose of Fludeoxyglucose F-18 used in a given patient should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed.

2.6 Drug Preparation and Administration

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Calculate the necessary volume to administer based on calibration time and dose.

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Aseptically withdraw Fludeoxyglucose F-18 Injection from its container.

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Inspect Fludeoxyglucose F-18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit.

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Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.

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Use Fludeoxyglucose F-18 Injection within 12 hours from the EOS.

2.7 Imaging Guidelines

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Initiate imaging within 40 minutes following Fludeoxyglucose F-18 Injection administration.

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Acquire static emission images 30 – 100 minutes from the time of injection.

3 DOSAGE FORMS AND STRENGTHS

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.

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

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.

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 possibility of interactions of Fludeoxyglucose F-18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

8 USE IN SPECIFIC POPULATIONS

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.

11 DESCRIPTION

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 C₆ H₁₁ ¹⁸ FO₅ 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.

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 annihilationFrom: 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. Radiation Attenuation of 511 keV Photons by Lead (Pb) and Tungsten (W) Alloy Shielding

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.

Table 4. Physical Decay Chart for Fluorine F-18

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