SODIUM FLUORIDE F 18- sodium fluoride f-18 injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM FLUORIDE F-18 (UNII: 9L75099X6R) (FLUORIDE ION F-18 - UNII:4M4WE5N2GE)

Available from:

BAMF Health Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. None. 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 radioactive 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 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.

Product summary:

Sodium Fluoride F 18 Injection, USP is supplied in a multiple-dose Type 1 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: 81759-002-30. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM FLUORIDE F 18- SODIUM FLUORIDE F-18 INJECTION
BAMF HEALTH INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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. APPROVAL: 1/2011
INDICATIONS AND USAGE
Sodium Fluoride F 18 Injection is a radioactive diagnostic agent for
positron emission tomography (PET)
indicated for imaging of bone to define areas of altered osteogenic
activity. (1)
DOSAGE AND ADMINISTRATION
• Sodium Fluoride F 18 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)
DOSAGE FORMS AND STRENGTHS
Multiple-dose vial containing 370-7,400 MBq/mL (10-200 mCi/mL) of
no-carrier-added sodium fluoride F 18
at the end of synthesis (EOS) reference time in aqueous 0.9% sodium
chloride solution ( 3). Sodium
Fluoride F 18 Injection, USP is a clear, colorless, sterile,
pyrogen-free, and preservative-free solution for
intravenous administration.
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
• Allergic Reactions: As with any injectable drug product, allergic
reactions and anaphylaxis may occur.
Emergency resuscitation equipment and personnel should be immediately
available. ( 5.1)
• Cancer Risks: Sodium Fluoride F 18 Injection may increase the risk
of cancer. Use the smallest dose
necessary for imaging and ensure safe handling to protect the patient
and health care worker. ( 5.2)
ADVERSE REACTIONS
No adverse reactions have