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

1.1 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.

1.2 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.

1.3 Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

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 Brigham and Women's Hospital, Inc.

at 617-732-7171 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.