SODIUM FLUORIDE F 18 Solution for injection Ref.[27555] Active ingredients: Sodium fluoride ¹⁸F

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 F18 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)].

No adverse reactions have been reported for Sodium Fluoride F18 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.

The possibility of interactions of Sodium Fluoride F18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

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 and developmental toxicity studies have not been conducted with Sodium Fluoride F18 Injection. Prior to the administration of Sodium Fluoride F18 Injection to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F18 Injection should be given to a pregnant woman only if clearly needed.

It is not known whether Sodium Fluoride F18 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 F18 Injection or not to administer Sodium Fluoride F18 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.