Sodium Fluoride F-18

Sodium Fluoride F-18 Injection, USP, is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. 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 ).

None None ( 4 ).

• 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 the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker ( 5.2 ).

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.

5.2Radiation Risks Sodium Fluoride F-18 Injection,

USP, may increase the risk of cancer. Carcinogenic and mutagenic studies with Sodium Fluoride F-18 Injection, USP, 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 ) ].

The possibility of interactions of Sodium Fluoride F-18 Injection, USP, with other drugs taken by patients undergoing PET imaging has not been studied.

8.1Pregnancy Pregnancy Category C

Any radiopharmaceutical including Sodium Fluoride F-18 Injection, USP, 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, USP. Prior to the administration of Sodium Fluoride F-18 Injection, USP, to women of childbearing potential, assess for presence of pregnancy.