Sodium Fluoride F 18

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Sodium Fluoride F18 Injection 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.
• 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.
• Recommended Dose for
• Adults Administer 300–450 MBq (8–12 mCi) as an intravenous injection.
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 2.7 Imaging Guidelines Imaging of Sodium Fluoride F 18 Injection can begin 1–2 hours after administration; optimally at 1 hour post administration.
• Encourage the patient to void immediately prior to imaging the fluoride F18 radioactivity in the lumbar spine or bony pelvis.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Use in children

• 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.

Quoted from the official label, section “Pediatric Use”.

Side effects

• 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.
• 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 (6).
• To report SUSPECTED ADVERSE REACTIONS, contact The University of Utah DBA Cyclotron Radiochemistry Lab Hunstman Cancer Institute at 1-801-581-8745 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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.
• 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.

Quoted from the official label, section “Dosage Forms & Strengths”.

How to store it

• 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.

Quoted from the official label, section “Storage and Handling”.

What is in it

• 11.1 Chemical Characteristics Sodium Fluoride F 18 Injection, USP 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+ 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 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 a total volume of approximately 8 to 10 mL and total radioactivity containing between 2,960 MBq to 74,000 MBq (80 to 2,000 mCi) 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 18 O-oxygen.
• Table 2:
• Principal Emission Data for Fluoride F18 Radiation/Emission % per Disintegration Mean Energy Positron (β+) 96.73 249.8 keV Gamma (±)* 193.46 511.0 keV * Produced by positron annihilation [3] Kocher, D.C.
• Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981.
• 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.
• Table 4:
• Physical Decay Chart for Fluoride F18 Time Since Calibration Fraction Remaining 0* 1.00 15 minutes 0.909 30 minutes 0.826 60 minutes 0.683 110 minutes 0.500 220 minutes 0.250 440 minutes 0.060 12 hours 0.011 24 hours 0.0001 * Calibration time

Quoted from the official label, section “Description”.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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