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These highlights do not include all the information needed to use Sodium Fluoride F 18 Injection, USP safely and effectively. See full prescribing information for Sodium Fluoride F 18 Injection, USP. SODIUM FLUORIDE F 18 INJECTION, USPFor Intravenous UseI | Sodium Fluoride F 18 [Biomedial Research Foundation of Northwest Lousiansa] | BioPortfolio

12:41 EST 27th January 2019 | BioPortfolio

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

Administer 300 MBq/mL to –450 MBq/mL (8 mCi/mL to 12 mCi/mL) as an intravenous injection.

In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq to 148 MBq (0.5 mCi to 4 mCi) were used.

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
Estimated Radiation Dose mGy/MBq
Organ Adult
70 kgData from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.
15 year
56.8 kgData from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals, Ann ICRP, Volume 18, pages15 and 74, 1987
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
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

Multiple-dose vial containing 370 MBq/mL to 7,400 MBq/mL (10 mCi/mL to 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 is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.

None.

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

Sodium Fluoride F 18 Injection may increase the risk of cancer. Carcinogenic and mutagenic studies with Sodium Fluoride F 18 Injection 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) ].

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.

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

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 reproduction 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.

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.

In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq to 148 MBq (0.5 mCi to 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.

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[F] with a molecular weight of 40.99, and has the following chemical structure:

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.

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 O-oxygen.

The specific gamma ray constant (point source air kerma coefficient) for fluoride F 18 is 5.7 R/hr/mCi (1.35 x 10 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 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 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 2: Principal Emission Data for Fluoride F 18
Radiation/Emission % per Disintegration Mean Energy
Positron (β+) 96.73 249.8 keV
Gamma (±)Produced by positron annihilation
[3] Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981.
193.46 511.0 keV
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: Physical Decay Chart for Fluoride F 18
Time Since Calibration Fraction Remaining
0Calibration time 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

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.

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.

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.

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

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.

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).

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 MBq/mL and 7,400 MBq/mL (10 mCi/mL to 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 shielding container of appropriate thickness.

The product is available in a 30 mL vial configuration with a variable fill volume. The NDC number is: 24562-002-30 (30mL)

Store at 20° to 25°C (68° to 77°F) in a shielded container; excursions permitted to 15° to 30°C (59°–86°F) [See USP Controlled Room Temperature]. Use the solution within 12 hours of the EOS reference time.

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.

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

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 for: Biomedical Research Foundation of Northwest LouisianaShreveport, LA 71103

Revised: 1/2015

NDC#24562-002-30Multiple-Dose Vial

Sodium Fluoride F 18 Injection, USP 10mCi/mL to 200mCi/mL (@ EOS*)

Activity @ EOS*: Total ________mCiVolume ________mLConcentration ________mCi/mL

Sterile, Non-pyrogenic

Calibration Time ______Calibration Date ______

Diagnostic - For Intravenous UseOnlyExp. Date/Time ______________Lot#______________(Expires 12 hours after EOS*)

Contains: 0.37 GBq to 7.4 GBq (10mCi/mL to 200mCi/mL) of no-carrier added Sodium Fluoride F 18 in aqueous 0.9% Sodium Chloride Solution @ EOS*.

Store at 20° to 25°C (68° to 77°F);excursion permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Store upright in a shielded container.Aseptically withdraw and handle doses.[F] Half-Life = 109.7 minutesCalculate correct dosage from date and time of calibration.

Do not use if cloudy or if it contains particulatematter.*EOS = End of Synthesis

CAUTION: RADIOACTIVE MATERIAL

Manufactured for:Biomedical Research Foundation ofNorthwest LouisianaShreveport, LA 71103

R ONLY

Manufacturer

Biomedial Research Foundation of Northwest Lousiansa

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