Sodium Fluoride

Precision Nuclear LLC

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Sodium Fluoride F 18 Injection safely and effectively. See full prescribing information for Sodium Fluoride F 18 Injection. SODIUM FLUORIDE F 18 INJECTION For Intravenous Use Initial U.S. Approval: 2011DOSAGE FORMS AND STRENGTHSMultiple-dose vial containing 370–7,400 MBq/mL (10-200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution(3). Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.Side EffectsNo adverse reactions have been reported for Sodium Fluoride F 18 Injection 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 Precision Nuclear LLC at 423-467-0050 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FULL PRESCRIBING INFORMATION: CONTENTS*

• 3 DOSAGE FORMS AND STRENGTHS
• 6 SODIUM FLUORIDE ADVERSE REACTIONS
• 11 SODIUM FLUORIDE DESCRIPTION
  • 11.1 Chemical Characteristics
  • 11.2 Physical Characteristics
• 16 HOW SUPPLIED
  • Storage
  • Handling
• Package Label/Principal Display Panel

FULL PRESCRIBING INFORMATION

3 DOSAGE FORMS AND STRENGTHS

Multiple-dose vial containing 370–7,400 MBq/mL (10-200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.

6 ADVERSE REACTIONS

No adverse reactions have been reported for Sodium Fluoride F 18 Injection 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.

11 DESCRIPTION

11.1 Chemical Characteristics

Sodium Fluoride F 18 Injection is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F18, has the molecular formula Na[¹⁸F] with a molecular weight of 40.99, and has the following chemical structure:

Na⁺ 18F^-

Sodium Fluoride F 18 Injection is provided as a ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution. Each mL of the solution contains between 370–7,400 MBq/mL (10-200 mCi/mL) sodium fluoride F18, 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 or 50 mL multiple- dose glass vials with variable total volume and total radioactivity in each vial.

11.2 Physical Characteristics

Fluoride F18 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 F18 atom decays to stable ¹⁸O-oxygen.

The specific gamma ray constant (point source air kerma coefficient) for fluoride F18 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). A range of values for the attenuation of radiation results from the interposition of various thickness of Pb. The range of attenuation coefficients for this radionuclide 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 4 lists the fraction of radioactivity remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide.

16 HOW SUPPLIED

Sodium Fluoride F 18 Injection is supplied in a multiple-dose Type I glass vial with (elastomeric) stopper and aluminum crimp seal containing between 370–7,400 MBq/mL (10-200 mCi/mL) of no-carrier-added sodium fluoride F18, 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 shielding container of appropriate thickness.

The product is available in a 30 mL or 50 mL vial configuration with a variable fill volume. The NDC numbers are:

52768-125-30 (30 mL vial)

52768-125-50 (50 mL vial)

Storage

Store at 25°C (77°F); 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.

Manufactured by: Precision Nuclear, LLC

830 Suncrest Dr

Gray, TN 37615

Distributed by: Precision Nuclear, LLC

830 Suncrest Dr

Gray, TN 37615

Package Label/Principal Display Panel

Vial Label

Package (lead shield) Label