Sodium Fluoride F 18 (Page 3 of 3)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to assess reproductive toxicity, mutagenesis, and carcinogenesis potential of Sodium Fluoride F 18 Injection, USP have not been performed.

14 CLINICAL STUDIES

14.1 Metastatic Bone Disease

The doses used in reported studies ranged from 2.7 mCi to 20 mCi (99.9 MBq to 740 MBq), with an average median dose of 10 mCi (370 MBq) and an average mean dose of 9.2 mCi (340.4 MBq). In PET imaging of bone metastases with Sodium Fluoride F 18 Injection, USP, focally increased tracer uptake is seen in both osteolytic and osteoblastic bone lesions. Negative PET imaging results with Sodium Fluoride F 18 Injection, USP do not preclude the diagnosis of bone metastases. Also, as benign bone lesions are also detected by Sodium Fluoride F 18 Injection, USP positive PET imaging results cannot replace biopsy to confirm a diagnosis of cancer.

14.2 Other Bone Disorders

The doses used in reported studies ranged from 2.43 mCi to 15 mCi (89.9 MBq to 555 MBq), with an average median dose of 8.0 mCi (296 MBq) and an average mean dose of 7.6 mCi (281.2 MBq).

15 REFERENCES

1. Stabin, M.G., Stubbs, J. B., and Toohey R. E., Radiation Dose Estimates for Radiopharmaceuticals, U.S. Nuclear Regulatory Commission report NUREG/CR-6345, page 10, 1996.
2. Radiation Dose to Patients from Radiopharmaceuticals, ICRP publication 53, Ann ICRP, 18, pages 15 and 74, 1987.
3. Kocher, D. C., “Radioactive Decay Data Tables: A Handbook of decay data for application to radiation dosimetry and radiological assessments” DOE/TIC-11026, page 69, 1981.

16 HOW SUPPLIED/STORAGE AND HANDLING

Sodium Fluoride F 18 Injection, USP is supplied in a multiple-dose Type 1 glass vial with elastomeric stopper and aluminum crimp seal containing between 740 and 22,200 MBq/mL (20-600 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 25 mL vial configuration with a variable fill volume. The NDC number is: 13267-542-42.

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.

17 PATIENT COUNSELING INFORMATION

17.1 Pre-study Hydration

Encourage patients to drink at least 500 mL of water prior to drug administration.

17.2 Post-study Voiding

To help protect themselves and others in their environment, patients should take the following precautions for 12 hours after injection: whenever possible, use a toilet and flush several times after each use; wash hands thoroughly after each voiding or fecal elimination. If blood, urine or feces soil clothing, wash the clothing separately.

Manufactured & Distributed by:
The Feinstein Institutes for Medical Research
Cyclotron/Radiochemistry Facility
350 Community Drive
Manhasset, New York 11030

PRINCIPAL DISPLAY PANEL

Sodium Fluoride F 18 Injection, USP
740 MBq/mL to 22,200 MBq/mL (20 mCi/mL to 600 mCi/mL) at End of Synthesis (EOS)
Diagnostic – For Intravenous Use Only
Sterile, Non-pyrogenic
NDC# 13267-542-42
25 mL Multiple-Dose Vial
CAUTION: RADIOACTIVE MATERIAL RX ONLYManufactured by The Feinstein Institutes for Medical Research, Manhasset, NY 11030

SODIUM FLUORIDE F 18 sodium fluoride f 18 injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13267-542 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE F-18 (FLUORIDE ION F-18) FLUORIDE ION F-18 600 mCi in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 9 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:13267-542-42 20 mL in 1 VIAL, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204328 11/19/2014

Labeler — THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH (110565913)

Revised: 11/2019 THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH