INDICATIONS AND USAGE
Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging. In these patients, 11C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration.
Limitation of Use: 11C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer (1).
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Imaging errors have been reported; blood PSA levels < 2 ng/mL have been associated with poor imaging performance.
Allergic reactions: have emergency resuscitation equipment and personnel readily available.
Radiation risk: Choline C 11 Injection contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect the patient and health care worker.
Exclusive of an uncommon, mild injection site reaction, no other adverse reactions have been reported.
Colchicine and androgen-deprivation therapeutic drugs may interfere with 11C-choline PET/CT imaging performance.
The above does not include all the information needed to use Choline C11 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.
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