Fludeoxyglucose F18
FDA Drug Information • Also known as: Fludeoxyglucose F18
- Brand Names
- Fludeoxyglucose F18
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11.0 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 directions when the positron interacts with an electron (Table 2). (*) 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 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511keV 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%. For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4. (*) Calibration time Table 2 Radiation Emission Data Table 3 Radiation Attenuation Table 4: Physical Decay Chart 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 C 6 H 11 18 FO 5 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 solution. Each mL contains between 0.740 to 11.1 GBq (20.0 - 300 mCi) of 2-deoxy-2-[ 18 F]fluoro-Dglucose 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...
What Is Fludeoxyglucose F18 Used For?
1. INDICATIONS AND USAGE Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures (1). 1.1 Oncology For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. 1.2 Cardiology For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. 1.3 Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. 1.1 Oncology For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. 1.2 Cardiology For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. 1.3 Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
Dosage and Administration
2. DOSAGE AND ADMINISTRATION Fludeoxyglucose F18 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 [ see Description(11.2) ]. Fludeoxyglucose F18 Injection emits radiation. Use procedures to minimize radiation exposure. Screen for blood glucose abnormalities. In the oncology and neurology settings, instruct patients to fast for 4 – 6 hours prior to the drug’s injection. Consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to the drug’s administration (5.2). In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to the drug’s injection facilitates localization of cardiac ischemia (2.3). Aseptically withdraw Fludeoxyglucose F18 Injection from its container and administer by intravenous injection (2). The recommended dose: for adults is 5 – 10 mCi (185 – 370 MBq), in all indicated clinical settings (2.1). for pediatric patients is 2.6 mCi (96.2 mBq) in the neurology setting (2.2). Initiate imaging within 40 minutes following drug injection; acquire static emission images 30 – 100 minutes from time of injection (2). 2.1 Recommended Dose for Adults Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection. 2.2 Recommended Dose for Pediatric Patients Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined [ see Use in Special Populations (8.4) ]. 2.3 Patient Preparation To minimize the radiation absorbed dose to the bladder, encourage adequate hydration.Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study. Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour. Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests [s ee Warnings and Precautions (5.2) ]. Prior to Fludeoxyglucose F 18 PET imaging in the oncology and neurology settings, instruct patient to fast for 4 – 6 hours prior to the drug’s injection. In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to Fludeoxyglucose F 18 Injection facilitates localization of cardiac ischemia. 2.4 Radiation Dosimetry The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F 18 Injection are shown in Table 1. These estimates were calculated based on...
Side Effects (Adverse Reactions)
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. Hypersensitivity reactions have occurred; have emergency resuscitation equipment and personnel immediately available (6) . To report SUSPECTED ADVERSE REACTIONS, contact The UT MDACC, Cyclotron Radiochemistry Facility at 713-563-5455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
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.
Contraindications
4. CONTRAINDICATIONS None None (4)
How Supplied
16. HOW SUPPLIED/STORAGE AND HANDLING Fludeoxyglucose F 18 Injection is supplied in a multi-dose, 30 mL glass vial containing: between 0.740 - 11.1 GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 27 mL. The contents of each vial are sterile, pyrogen-free and preservative free. NDC 60215-411-30 16.1 Storage Store the Fludeoxyglucose F 18 Injection vial upright in a shielded container at 10 - 25°C (50 - 77°F), excursions permitted to 15 - 30°C (59 - 86°F) [ See USP Controlled Room Temperature ]. 16.2 Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate. 16.1 Storage Store the Fludeoxyglucose F 18 Injection vial upright in a shielded container at 10 - 25°C (50 - 77°F), excursions permitted to 15 - 30°C (59 - 86°F) [ See USP Controlled Room Temperature ]. 16.2 Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.