Prescription Drug Information: 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 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 (100 MBq to 740 MBq), with an average median dose of 10 mCi (370 MBq) and an average mean dose of 9.2 mCi (340 MBq). In PET imaging of bone metastases with Sodium Fluoride F 18 Injection, focally increased tracer uptake is seen in both osteolytic and osteoblastic bone lesions. Negative PET imaging results with Sodium Fluoride F 18 Injection do not preclude the diagnosis of bone metastases. Also, as benign bone lesions are also detected by Sodium Fluoride F 18 Injection, 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 (90 MBq to 555 MBq), with an average median dose of 8.0 mCi (300 MBq) and an average mean dose of 7.6 mCi (280 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 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 F18, at the EOS reference time, in aqueous 0.9% sodium chloride solution. The total volume is approximately 8 to 10 mL and total radioactivity per vial contains between 2,960 MBq to 74,000 MBq (80 to 2,000 mCi). Each vial is enclosed in a shielded container of appropriate thickness.

The product is available in a 30 mL vial configuration with an approximate 8 to 10 mL fill volume. The NDC number is:


67939-020-10

Storage

Store at 25°C (77°F) in a shielded container; excursions permitted to 15–30°C (59–86°F). Use the solution within 10 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 by:
The University of Utah DBA Cyclotron Radiochemistry Lab Hunstman Cancer Institute
2000 Circle of Hope, UT 84112

Distributed by:

The University of Utah DBA Cyclotron Radiochemistry Lab Hunstman Cancer Institute 2000 Circle of Hope, UT 84112

Sodium Fluoride F 18 Injection 10 mL (67939-020-10)

  • Vial Label
SodiumFluorideVialLabe
(click image for full-size original)
  • Outer Packaging — Container Label
SodiumFluorideOuterPackagingLabel
(click image for full-size original)
SODIUM FLUORIDE F 18 sodium fluoride f 18 injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67939-020
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-18 200 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67939-020-10 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204497 07/11/2012
Labeler — The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute (018432646)
Registrant — The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute (018432646)
Establishment
Name Address ID/FEI Operations
The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute 018432646 positron emission tomography drug production (67939-020), manufacture (67939-020)

Revised: 09/2020 The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute

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