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:

The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute

INN (International Name):

SODIUM FLUORIDE F-18

Composition:

FLUORIDE ION F-18 200 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 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 Sodi

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 between 370 and 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 is approximately 8 to 10 mL and total radioactivity per vial contains between 2,960 MBq to 74,000 MBq (80 to 2,000 mCi). Each vial is enclosed in a shielded container of appropriate thickness. The product is available in a 30 mL vial configuration with an approximate 8 to 10 mL fill volume. The NDC number is: 67939-020-10 Storage Store at 25°C (77°F) in a shielded container; excursions permitted to 15–30°C (59–86°F). Use the solution within 10 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
THE UNIVERSITY OF UTAH DBA CYCLOTRON RADIOCHEMISTRY LAB HUNTSMAN
CANCER
INSTITUTE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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. SODIUM FLUORIDE F18 INJECTION, USP
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2011
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). (1)
DOSAGE AND ADMINISTRATION
Sodium Fluoride F18 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
F18 at the end of synthesis (EOS) reference time 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. (3)
CONTRAINDICATIONS
None (4). (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 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 (