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 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).

Multiple-dose vial containing 370–7.400 MBq/mL (10–200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution.  Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.

• Pregnancy: No human or animal data. Any radiopharmaceutical, including Sodium Fluoride F18 injection, may cause fetal harm. Use only if clearly needed (8.1)
  
  
  
  
  
  
  
  
  
  
  
• Nursing: A decision should be made whether to interrupt nursing after Sodium Fluoride F 18 Injection administration or not to administer Sodium Fluoride F 18 Injection taking into consideration the importance of the drug to the mother. (8.3)
  
  
  
  
  
  
  
  
  
  
  
• Pediatrics: Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F18 injection (8.4).

• 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 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).