Fludeoxyglucose F 18 Injection

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.

DOCUMENTATION

The above does not include all the information needed to use Fludeoxyglucose F 18 Injection safely and effectively. For complete Warnings and Precautions and Adverse Reactions, as well as Dosage and Administration and other important information see the Full Prescribing Information.

Click below for full prescribing information.

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