SODIUM FLUORIDE F 18- sodium fluoride f-18 injection
Sodium Fluoride by
Drug Labeling and Warnings
Sodium Fluoride by is a Prescription medication manufactured, distributed, or labeled by Houston Cyclotron Partners LP dba Cyclotope. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
-
HIGHLIGHTS OF PRESCRIBING INFORMATION
These 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 AND ADMINISTRATION
- Sodium Fluoride F18 Injection emits radiation and must be handled with appropriate safety measures (2.1).
- Administer 300-450 MBq (8 to 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).
DOSAGE FORMS AND STRENGTHS
Multiple-dose vial containing 370–7,400 MBq/mL (10–200 mCi/mL) of no-carrier-added sodium fluoride F18 at the end of synthesis (EOS) reference time 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.
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. (3)
To report SUSPECTED ADVERSE REACTIONS, contact CYCLOTOPE at 1-713-747-5686 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (3)
USE IN SPECIFIC POPULATIONS
- Pregnancy: No human or animal data. Any radiopharmaceutical, including Sodium Fluoride F18 injection, may cause fetal harm. Use only if clearly needed (8.1)
- Nursing: A decision should be made whether to interrupt nursing after Sodium Fluoride F 18 Injection administration or not to administer Sodium Fluoride F 18 Injection taking into consideration the importance of the drug to the mother. (8.3)
- Pediatrics: Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F18 injection (8.4).
Revised: 9/2012
-
Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
2 DOSAGE AND ADMINISTRATION
2.1 Radiation Safety - Drug Handling
2.2 Radiation Safety - Patient Preparation
2.3 Drug Preparation and Administration
2.4 Recommended Dose for Adults
2.5 Recommended Dose for Pediatric Patients
2.6 Radiation Dosimetry
2.7 Imaging Guidelines
3 DOSAGE FORMS AND STRENGTHS
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
15 REFERENCES
11 DESCRIPTION
11.1 Chemical Characteristics
11.2 Physical Characteristics
16 HOW SUPPLIED / STORAGE AND HANDLING
- * Sections or subsections omitted from the full prescribing information are not listed.
-
2 DOSAGE AND ADMINISTRATION
2.1 Radiation Safety - Drug Handling
- Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection. 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.
- The dose of Sodium Fluoride F 18 Injection 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.
- Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection 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 visually for particulate matter and discoloration before administration, whenever solution and container permit.
- Do not administer Sodium Fluoride F 18 Injection 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 from its container.
2.5 Recommended Dose for Pediatric Patients
In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq– 148 MBq (0.5 mCi- 4 mCi) were used.
2.6 Radiation Dosimetry
The age/weight- based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F 18 Injection are shown in Table 1. These estimates were calculated based on human data and using the data published by the Nuclear Regulatory Commission [1] and the International Commission on Radiological Protection for Sodium Fluoride Injection [2]. The bone, bone marrow and urinary bladder are considered target and critical organs.
Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection Organ Estimated Radiation Dose mGy/MBq Adult 70 kg [1] 15 year 56.8 kg [2] 10 year 33.2 kg [2] 5 year 19.8 kg [2] 1 year 9.7 kg [2] Adrenals 0.0062 0.012 0.018 0.028 0.052 Brain 0.0056 N/A N/A N/A N/A Bone surfaces 0.060 0.050 0.079 0.13 0.30 Breasts 0.0028 0.0061 0.0097 0.015 0.030 GI Gallbladder wall 0.0044 N/A N/A N/A N/A Stomach wall 0.0038 0.008 0.013 0.019 0.036 Small intestine 0.0066 0.012 0.018 0.028 0.052 Upper large intestine wall 0.0058 0.010 0.016 0.026 0.046 Lower large intestine wall 0.012 0.016 0.025 0.037 0.063 Heart wall 0.0039 N/A N/A N/A N/A Kidneys 0.019 0.025 0.036 0.053 0.097 Liver 0.0040 0.0084 0.013 0.021 0.039 Lungs 0.0041 0.0084 0.013 0.020 0.039 Muscle 0.0060 N/A N/A N/A N/A Ovaries 0.011 0.016 0.023 0.036 0.063 Pancreas 0.0048 0.0096 0.015 0.023 0.044 Red marrow 0.028 0.053 0.088 0.18 0.38 Skin 0.0040 N/A N/A N/A N/A Spleen 0.0042 0.0088 0.014 0.021 0.041 Testes 0.0078 0.013 0.021 0.033 0.062 Thymus 0.0035 N/A N/A N/A N/A Thyroid 0.0044 0.0084 0.013 0.020 0.036 Urinary bladder wall 0.25 0.27 0.4 0.61 1.1 Uterus 0.019 0.023 0.037 0.057 0.099 Other tissue N/A 0.010 0.015 0.024 0.044 Effective Dose Equivalent mSv/MBq 0.027 0.034 0.052 0.086 0.17 [1] Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.
[2] Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals , Ann ICRP, Volume 18, pages 15 and 74, 1987
-
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
-
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C
Any radiopharmaceutical including Sodium Fluoride F 18 Injection 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. Prior to the administration of Sodium Fluoride F 18 Injection to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F 18 Injection 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 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 or not to administer Sodium Fluoride F 18 Injection, 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.
8.4 Pediatric Use
In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq–148 MBq (0.5 mCi - 4 mCi) were used. Sodium Fluoride F18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F18 injection.
-
15 REFERENCES
- 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.
- Radiation Dose to Patients from Radiopharmaceuticals, ICRP publication 53, Ann ICRP, 18 pages 15 and 74, 1987
- 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.
-
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 (10-200 mCi) 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 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.
Table 2: Principal Emission Data for Fluoride F18 Radiation/Emission % per Disintegration Mean Energy - * Produced by positron annihilation [3] Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981.
Positron (β+) 96.73 249.8 keV Gamma (±) * 193.46 511.0 keV The specific gamma ray constant 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 4.1 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 8.3 mm thickness of Pb with a coefficient of attenuation of 0.25 will decrease the external radiation by 75%.
Table 3:Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 0 0.00 4 0.50 8 0.25 13 0.10 26 0.01 39 0.001 52 0.0001 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 / STORAGE AND HANDLING
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 vial configuration with a variable fill volume. The NDC number is:
47584-002-01 (30 mL)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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SODIUM FLUORIDE F 18
sodium fluoride f-18 injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 47584-002 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE F-18 (UNII: 9L75099X6R) (FLUORIDE ION F-18 - UNII:4M4WE5N2GE) FLUORIDE ION F-18 200 mCi in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 47584-002-01 30 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/08/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203544 12/08/2011 Labeler - Houston Cyclotron Partners LP dba Cyclotope (118258354) Establishment Name Address ID/FEI Business Operations Houston Cyclotron Partners LP dba Cyclotope 118258354 positron emission tomography drug production(47584-002)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.