Fludeoxyglucose F-18

1 INDICATIONS AND USAGE Fludeoxyglucose F18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F 18 Injection, USP 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.

6 ADVERSE REACTIONS Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available. Hypersensitivity reactions have occurred; have emergency resuscitation equipment and personnel immediately available (6) . To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc., Jubilant Radiopharma at 1-877-301-0106 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary Data from published case series and case reports describe Fludeoxyglucose F 18 Injection crossing the placenta with uptake by the fetus (see Data). All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. However, published studies that describe Fludeoxyglucose F 18 Injection use in pregnant women have not identified a risk of drug-associated major birth defects, miscarriage, or adverse maternal or fetal outcomes.

5 WARNINGS AND PRECAUTIONS Radiation risks: use smallest dose necessary for imaging (5.1) . Blood glucose abnormalities: may cause suboptimal imaging (5.2) . 5.1 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 [ see Dosage and Administration (2.5) ]. 5.2 Blood Glucose Abnormalities In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. 4 CONTRAINDICATIONS None None (4)