Fludeoxyglucose F 18 Drug Information

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.

Recommended Dose for Adults Within the oncology, cardiology and neurology settings, the recommended dose for adults is MBq as an intravenous injection.

Recommended Dose for Pediatric Patients Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined.

Patient Preparation •

To minimize the radiation absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study. • Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour. • Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests. These estimates were calculated based on human 2 data and using the data published by the International Commission on Radiological Protection 4 for Fludeoxyglucose 18 F.

The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.

Table 1. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F-18 Injection a

Radiation Safety – Drug Handling •

Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Fludeoxyglucose F-18 Injection to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel and other persons. • Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. • Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient. • The dose of Fludeoxyglucose F-18 used in a given patient should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed.

Drug Preparation and Administration • Calculate the necessary volume to administer based on calibration time and dose. • Aseptically withdraw Fludeoxyglucose F-18 Injection from its container. • Inspect Fludeoxyglucose F-18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. • Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. • Use Fludeoxyglucose F-18 Injection within 12 hours from the EOS.

Imaging Guidelines •

Initiate imaging within 40 minutes following Fludeoxyglucose F-18 Injection administration. • Acquire static emission images 30 – 100 minutes from the time of injection.

Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available. To report SUSPECTED ADVERSE REACTIONS, contact Cardinal Health at 1-800-618-2768 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The possibility of interactions of Fludeoxyglucose F-18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Fludeoxyglucose F-18 Injection. It is also not known whether Fludeoxyglucose F-18 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Consider alternative diagnostic tests in a pregnant woman; administer Fludeoxyglucose F-18 Injection only if clearly needed.

Pediatric Use The safety and effectiveness of Fludeoxyglucose F-18 Injection in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined.

In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F-18 Injection have not been established in pediatric patients.