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.

None. None.

• 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, 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.

No adverse reactions have been reported for Sodium Fluoride F 18 Injection, USP 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. No adverse reactions have been reported for Sodium Fluoride F 18 Injection, USP based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems.