PET/CT imaging is a safe, noninvasive nuclear medicine or molecular imaging procedure.
Radiopharmaceuticals are approved by the Food and Drug Administration and prepared with great care. They are tested carefully prior to general use. Nuclear imaging has been used for more than five decades and side effects are rare. While exposure to radiation does involve risk, naturally occurring background radiation and activities such as watching television and flying in an airplane all contribute to a lifetime exposure that is only slightly increased by medical imaging. Your physician has determined that the benefits of early and accurate diagnosis outweigh the risk of exposure to this small quantity of radioactive material.
FLUDEOXYGLUCOSE F 18 INJECTION, USP
For Intravenous Use
INDICATIONS AND USAGE
Fludeoxyglucose F 18 injection (18F FDG) is indicated for positron emission tomography (PET) imaging in the following settings:
Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
IMPORTANT SAFETY INFORMATION
Radiation Risks: Radiation-emitting products, including fludeoxyglucose F 18 injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.
Blood Glucose Abnormalities: In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to fludeoxyglucose F18 injection administration.
Adverse Reactions: Hypersensitivity reactions with pruritus, edema and rash have been reported; have emergency resuscitation equipment and personnel immediately available.
SODIUM FLUORIDE F 18 INJECTION
For Intravenous Use
INDICATIONS AND USAGE
Sodium Fluoride F 18 Injection is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity.
IMPORTANT SAFETY INFORMATION
Allergic Reactions: As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available.
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.
ADVERSE REACTIONS
No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting system.