SODIUM FLUORIDE F18 injection

Sodium Fluoride by

Drug Labeling and Warnings

Sodium Fluoride by is a Prescription medication manufactured, distributed, or labeled by Cardinal Health 414, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    Sodium Fluoride F-18 Injection, USP, is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Radiation Safety - Drug Handling

    • Wear waterproof gloves and effective shielding when handling Sodium Fluoride F-18 Injection, USP. 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, USP.
    • The dose of Sodium Fluoride F-18 Injection, USP, 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, USP.
    • Encourage the patient to void one-half hour after administration of Sodium Fluoride F-18 Injection, USP, 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, USP, visually for particulate matter and discoloration before administration, whenever solution and container permit.
    • Do not administer Sodium Fluoride F-18 Injection, USP, 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, USP, from its container.

    2.4 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, USP, 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, USP
  • * Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.
  • † Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals, Ann ICRP, Volume 18, pages 15 and 74, 1987.
    		•

    Organ

    Estimated Radiation Dose mGy/MBq

    Adult
       70 kg*   

    15 year
       56.8 kg†   

    10 year
       33.2 kg†   

    5 year
       19.8 kg†   

    1 year
       9.7 kg†   

    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

    2.7 Imaging Guidelines

    • Imaging of Sodium Fluoride F-18 Injection, USP, can begin 1–2 hours after administration; optimally at 1 hour post administration.
    • Encourage the patient to void immediately prior to imaging the fluoride F-18 radioactivity in the lumbar spine or bony pelvis.
  • 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 F-18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride F-18 Injection, USP, is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.

  • 4 CONTRAINDICATIONS

    None

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Allergic Reactions

    As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available.

    5.2 Radiation Risks

    Sodium Fluoride F-18 Injection, USP, may increase the risk of cancer. Carcinogenic and mutagenic studies with Sodium Fluoride F-18 Injection, USP, have not been performed. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration (2.1)].

  • 6 ADVERSE REACTIONS

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

  • 7 DRUG INTERACTIONS

    The possibility of interactions of Sodium Fluoride F-18 Injection, USP, with other drugs taken by patients undergoing PET imaging has not been studied.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Pregnancy Category C

    Any radiopharmaceutical including Sodium Fluoride F-18 Injection, USP, 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, USP. Prior to the administration of Sodium Fluoride F-18 Injection, USP, to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F-18 Injection, USP, 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, USP, 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, USP, or not to administer Sodium Fluoride F-18 Injection, USP, 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 F-18 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 F-18 Injection, USP.

  • 11 DESCRIPTION

    11.1 Chemical Characteristics

    Sodium Fluoride F-18 Injection, USP, is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F-18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F-18, 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, 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 F-18, 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 F-18 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 F-18 atom decays to stable 18O-oxygen.

    Table 2. Principal Emission Data for Fluoride F-18
  • * Produced by positron annihilation
    From: Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981
    		•

       Radiation/Emission   

       % Per Disintegration   

       Mean Energy   

    Positron(β+)

    96.73

    249.8 keV

    Gamma(±)*

    193.46

    511.0 keV

    The specific gamma ray constant for fluoride F-18 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) or 2.9 mm tungsten (W) alloy. A range of values for the attenuation of radiation results from the interposition of various thickness of Pb or Tungsten alloy. 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 or 5.8 mm thickness of W alloy 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) and Tungsten (W) alloy shielding

       Shield Thickness   
    (Pb) mm

       Shield Thickness   
    (W) Alloy mm

       Coefficient of   
    Attenuation

    0

    0

    0.00

    4

    3

    0.50

    8

    6

    0.25

    13

    9

    0.10

    26

    19

    0.01

    39

    28

    0.001

    53

    37

    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 F-18
  • * calibration time
    		•

       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
  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Fluoride F-18 ion normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition in the bones around joints than in the shafts of long bones.

    12.2 Pharmacodynamics

    Increased fluoride F-18 ion deposition in bone can occur in areas of increased osteogenic activity during growth, infection, malignancy (primary or metastatic) following trauma, or inflammation of bone.

    12.3 Pharmacokinetics

    After intravenous administration, fluoride F-18 ion is rapidly cleared from the plasma in a biexponential manner. The first phase has a half-life of 0.4 h, and the second phase has a half-life of 2.6 h. Essentially all the fluoride F-18 that is delivered to bone by the blood is retained in the bone. One hour after administration of fluoride, F-18 only about 10% of the injected dose remains in the blood. Fluoride F-18 diffuses through capillaries into bone extracellular fluid space, where it becomes bound by chemisorption at the surface of bone crystals, preferentially at sites of newly mineralizing bone.

    Deposition of fluoride F-18 in bone appears to be primarily a function of blood flow to the bone and the efficiency of the bone in extracting the fluoride F-18. Fluoride F-18 does not appear to be bound to serum proteins.

    In patients with normal renal function, 20% or more of the fluorine ion is cleared from the body in the urine within the first 2 hours after intravenous administration.

  • 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 (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, 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 (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 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 30 mL vial configuration with a variable fill volume. The NDC number is:

    NDC: 65857-300-30

    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 by:
    Cardinal Health 414, LLC
    7000 Cardinal Place
    Dublin, OH 43017

    Distributed by:
    Cardinal Health 414, LLC
    7000 Cardinal Place
    Dublin, OH 43017

  • PRINCIPAL DISPLAY PANEL - CARTON LABEL

    Principal Display Panel - Carton Label

    Carton Label

    NDC # 65857-300-30

    Sodium Fluoride F-18 Injection, USP
    10 - 200 mCi/mL at End of Synthesis (EOS)
    Diagnostic - For Intravenous Use Only

    Lot #: ______________________________________________
    EOS Date: _____/_____/_____       EOS Time: ______________
    Activity @ EOS: __________________________________ mCi
    Concentration: ___________mCi/mL   Volume: __________mL
    Exp. Date: _____/_____/_____       Exp. Time: ______________  

    Each mL Contains:
    0.37 to 7.4 GBq (10 to 200 mCi) of no-carrier added sodium [18F]fluoride in aqueous 0.9%
    sodium chloride solution at EOS. Use within 12 hours of EOS.

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room
    temperature]. Store upright in shielded container. Aseptically withdraw and handle doses.

    Do not use if cloudy or if it contains particulate matter.
    Calculate correct dosage from date and time of calibration.

    Sterile, Non-pyrogenic     30 mL Multiple-Dose Vial

    18F Half-life = 109.7 min                            Rx ONLY

    CAUTION:
    RADIOACTIVE
    MATERIAL

    Manufactured and Distributed by:
    Cardinal Health 414, LLC
    7000 Cardinal Place, Dublin, OH 43017

  • INGREDIENTS AND APPEARANCE
    SODIUM FLUORIDE  F18
    sodium fluoride f18 injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65857-300
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE F-18 (UNII: 9L75099X6R) (FLUORIDE ION F-18 - UNII:4M4WE5N2GE) FLUORIDE ION F-18200 mCi  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 65857-300-3030 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product07/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20378007/30/2015
    Labeler - Cardinal Health 414, LLC (069410546)
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