None known

General

[18F]FDG uptake may be changed by fasting or by blood sugar changes associated with diabetic mellitus. Blood glucose levels should be stabilized in non-diabetic patients by fasting before [18F]FDG injection. Diabetic patients may need stabilization of blood glucose on the day preceding, and on the day of the [18F]FDG scan.

Patients should be monitored for arrhythmias and other manifestations of ischemia. [18F]FDG, ClDG and their metabolites theoretically could inhibit glucose metabolism. Their ability to potentiate the arrhythmogenic effects of ischemia has not been studied.

The contents of each vial are sterile and non-pyrogenic. To maintain sterility, aseptic technique must be used during all operations involved in the manipulation and administration of [18F]FDG.

[18F]FDG should be used within 12 hours of the end of synthesis (EOS).  

As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other persons.

Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with [18F]FDG have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with [18F]FDG. It is not known whether [18F]FDG can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, [18F]FDG should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when [18F]FDG is administered to a nursing woman.

Pediatric Use

See Clinical Trials Section.

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