Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Exclusive of an uncommon, mild injection site reaction, no adverse reactions to 11 C-choline have been reported.
Exclusive of an uncommon, mild injection site reaction, no other adverse reactions have been reported ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Division of Nuclear Medicine, Department of Radiology, Mayo Clinic at 507-284-2511 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
5 WARNINGS AND PRECAUTIONS Imaging errors have been reported;
blood PSA levels < 2 ng/mL have been associated with poor imaging performance ( 5.1 ).
Allergic reactions: have emergency resuscitation equipment and personnel readily available ( 5.2 ).
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 ( 5.3 ).
Like all medications, Choline C 11 can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: