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:

Mayo Clinic

INN (International Name):

SODIUM FLUORIDE F-18

Composition:

FLUORIDE ION F-18 91.5 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Fluoride F 18 Injection USP 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 USP has the 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. 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. In reported clinical experience in approximately 100 children, weight-based doses (2.1 MBq/kg) ranging from 19 MBq-148 MBq (0.5-4 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.

Product summary:

Sodium Fluoride F 18 Injection USP is supplied in a multiple-dose Type I glass vial with elastomeric stopper and aluminum crimp seal containing 370 and 3,386 MBq/mL (10-91.5 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: 52670-550-30 (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 8 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
MAYO CLINIC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM FLUORIDE F 18
INJECTION USPSAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR SODIUM FLUORIDE F
18 INJECTION USP.
SODIUM FLUORIDE F 18 INJECTION USP
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL:XXXX
INDICATIONS AND USAGE
Sodium Fluoride F 18 Injection USP 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 USP 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 370-3,386 MBq/mL (10-91.5 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 Risk: Sodium Fluoride F 18 Injection USP may increase the risk
of cancer. Use of 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 been reported