Sodium Fluoride F18

FDA Drug Information • Also known as: Sodium Fluoride F18

Brand Names: Sodium Fluoride F18
Route: INTRAVENOUS
Dosage Form: INJECTION
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION 11.1 Chemical Characteristics Sodium Fluoride F-18 Injection, USP, is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F-18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F-18, has the molecular formula Na[ 18 F] with a molecular weight of 40.99, and has the following chemical structure: Na +18 F – Sodium Fluoride F-18 Injection, USP, is provided as a ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution. Each mL of the solution contains between 370 MBq to 7,400 MBq (10 mCi to 200 mCi) sodium fluoride F-18, at the EOS reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 and 8. The solution is presented in 30 mL multiple-dose glass vials with variable total volume and total radioactivity in each vial. 11.2 Physical Characteristics Fluoride F-18 decays by positron (β+) emission and has a half-life of 109.7 minutes. Ninety-seven percent of the decay results in emission of a positron with a maximum energy of 633 keV and 3% of the decay results in electron capture with subsequent emission of characteristic X-rays of oxygen. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron ( Table 2 ). Fluorine F-18 atom decays to stable 18 O-oxygen. Table 2. Principal Emission Data for Fluoride F-18 Radiation/Emission % Per Disintegration Mean Energy Positron(β+) 96.73 249.8 keV Gamma(±) Produced by positron annihilation From: Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981 193.46 511.0 keV The specific gamma ray constant for fluoride 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 4.1 mm lead (Pb) or 2.9 mm tungsten (W) alloy. A range of values for the attenuation of...

What Is Sodium Fluoride F18 Used For?

1 INDICATIONS AND USAGE Sodium Fluoride F-18 Injection, USP, is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F-18 Injection, USP, is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity ( 1 ).

Dosage and Administration

2 DOSAGE AND ADMINISTRATION

Sodium Fluoride F-18 Injection, USP, emits radiation and must be handled with appropriate safety measures ( 2.1 ).

Administer 300-450 MBq (8–12 mCi) as an intravenous injection in adults ( 2.4 ).

Administer approximately 2.1 MBq/kg in children with a minimum of 19 MBq (0.5 mCi) and a maximum of 148 MBq (4 mCi) as an intravenous injection ( 2.5 ).

Imaging can begin 1–2 hours after administration; optimally at one hour post administration ( 2.7 ).

Encourage patients to void immediately prior to imaging the lumbar spine and bony pelvis ( 2.7 ). 2.1 Radiation Safety - Drug Handling

Wear waterproof gloves and effective shielding when handling Sodium Fluoride F-18 Injection, USP. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons.

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.

Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F-18 Injection, USP.

The dose of Sodium Fluoride F-18 Injection, USP, should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed.

The final dose for the patient should be calculated using proper decay factors from the time of End of Synthesis (EOS), and measured by a suitable radioactivity calibration system before administration [ see Description ( 11.2 ) ]. 2.2 Radiation Safety - Patient Preparation

To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsequent to the administration of Sodium Fluoride F-18 Injection, USP.

Encourage the patient to void one-half hour after administration of Sodium Fluoride F-18 Injection, USP, and as frequently thereafter as possible for the next 12 hours. 2.3 Drug Preparation and Administration

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

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

Do not administer Sodium Fluoride F-18 Injection, USP, containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.

Aseptically withdraw Sodium Fluoride F-18 Injection, USP, from its container. 2.4 Recommended Dose for Adults Administer 300–450 MBq (8–12 mCi) as an intravenous injection. 2.5 Recommended Dose for Pediatric Patients...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS No adverse reactions have been reported for Sodium Fluoride F-18 Injection, USP, based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Sodium Fluoride F-18 Injection, USP, based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Cardinal Health at 1-800-618-2768 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drug Interactions

7 DRUG INTERACTIONS The possibility of interactions of Sodium Fluoride F-18 Injection, USP, with other drugs taken by patients undergoing PET imaging has not been studied.

Contraindications

4 CONTRAINDICATIONS None None ( 4 ).

Pregnancy and Breastfeeding

8.1 Pregnancy Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F-18 Injection, USP, has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. Animal reproductive and developmental toxicity studies have not been conducted with Sodium Fluoride F-18 Injection, USP. Prior to the administration of Sodium Fluoride F-18 Injection, USP, to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F-18 Injection, USP, should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers It is not known whether Sodium Fluoride F-18 Injection, USP, is excreted into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of Sodium Fluoride F-18 Injection, USP, or not to administer Sodium Fluoride F-18 Injection, USP, taking into account the importance of the drug to the mother. The body of scientific information related to radioactivity decay, drug tissue distribution and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours (10 half-lives). To minimize the risks to a nursing infant, interrupt nursing for at least 24 hours.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Sodium Fluoride F-18 Injection, USP, is supplied in a multiple-dose Type I glass vial with elastomeric stopper and aluminum crimp seal containing between 370 and 7,400 MBq/mL (10–200 mCi/mL) of no carrier-added sodium fluoride F-18, at the EOS reference time, in aqueous 0.9% sodium chloride solution. The total volume and total radioactivity per vial are variable. Each vial is enclosed in a shielded container of appropriate thickness. The product is available in a 30 mL vial configuration with a variable fill volume. The NDC number is: NDC 65857-300-30 Storage Store at 25°C (77°F) in a shielded container; excursions permitted to 15–30°C (59–86°F). Use the solution within 12 hours of the EOS reference time. 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.