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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. A | Sodium Fluoride [Houston Cyclotron Partners LP dba Cyclotope] | BioPortfolio

16:46 EST 26th January 2019 | BioPortfolio

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

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.

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.

[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

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

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.

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.

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.

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–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.

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

Na F

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.

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 O-oxygen.

The specific gamma ray constant for fluoride F18 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 4.1 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 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 F18
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 F18
Time Since Calibration Fraction Remaining
0 Calibration 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

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.

Manufactured and distributed by: Cyclotope Accelerated Medicine 8285 El Rio Suite 160 Houston, TX 77054 USA

LABEL ON THE DRUG VIAL AND LEAD SHIPPING CONTAINER

Manufacturer

Houston Cyclotron Partners LP dba Cyclotope

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