8.1 Pregnancy Pregnancy Category C. There are no adequate and well controlled studies with Choline C 11 Injection in pregnant women and the fetal radiation dose from a 11 C-choline PET imaging study is unknown. It is not known whether Choline C 11 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with 11 C-choline. All radiopharmaceuticals, including Choline C 11 Injection, have a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose. Assess pregnancy status before administering Choline C 11 Injection to a female of child bearing potential. Choline C 11 Injection should be given to a pregnant woman only if clearly needed.
Androgen-deprivation therapy may interfere with 11C-choline PET imaging performance. Impact depends on hormonal responsiveness; imaging may be unproductive in hormone-responsive cancer patients but potentially useful in hormone-resistant cases.
Colchicine may interfere with choline-based PET imaging, potentially causing failed or insufficient uptake and unproductive or misleading imaging results.