Sodium Fluoride F 18

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Overview

What is Sodium Fluoride F 18?

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 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 10-50 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 (point source air kerma coefficient) 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 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 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: 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

What does Sodium Fluoride F 18 look like?

What are the available doses of Sodium Fluoride F 18?

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(3). Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.

What should I talk to my health care provider before I take Sodium Fluoride F 18?

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F18 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. 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.

How should I use Sodium Fluoride F 18?

1 INDICATIONS AND USAGE Sodium Fluoride F 18 Injection 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. 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 EOS, and measured by a suitable radioactivity calibration system before administration [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. 2.4 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 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.

†Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals (), Ann ICRP, Volume 18, pages 15 and 74, 1987

What interacts with Sodium Fluoride F 18?

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What are the warnings of Sodium Fluoride F 18?

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What are the precautions of Sodium Fluoride F 18?

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What are the side effects of Sodium Fluoride F 18?

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What should I look out for while using Sodium Fluoride F 18?

4 CONTRAINDICATIONS None.

What might happen if I take too much Sodium Fluoride F 18?

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How should I store and handle Sodium Fluoride F 18?

16 HOW SUPPLIED Sodium Fluoride F 18 Injection is supplied in a multiple-dose glass vial with (elastomeric) stopper and aluminum crimp seal containing between 370-7,400 MBq/mL (10 to 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 10-50 mL vial configuration with a variable fill volume. The NDC number is: 13108-211-10 (10 mL) 13108-211-25 (25 mL) 13108-211-30 (30 mL) 13108-211-50 (50 mL) Storage Store at 25°C (77°F); 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. 16 HOW SUPPLIED Sodium Fluoride F 18 Injection is supplied in a multiple-dose glass vial with (elastomeric) stopper and aluminum crimp seal containing between 370-7,400 MBq/mL (10 to 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 10-50 mL vial configuration with a variable fill volume. The NDC number is: 13108-211-10 (10 mL) 13108-211-25 (25 mL) 13108-211-30 (30 mL) 13108-211-50 (50 mL) Storage Store at 25°C (77°F); 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.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Fluoride F18 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 F18 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 F18 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 F18 that is delivered to bone by the blood is retained in the bone. One hour after administration of fluoride F18 only about 10% of the injected dose remains in the blood. Fluoride F18 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 F18 in bone appears to be primarily a function of blood flow to the bone and the efficiency of the bone in extracting the fluoride F18. Fluoride F18 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.

Non-Clinical Toxicology

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 may increase the risk of cancer. Carcinogenic and mutagenic studies with Sodium Fluoride F18 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)].

6 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. However, the completeness of these sources is not known.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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