Based on findings from animal reproduction studies and its mechanism of action, Cobimetinib can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Cobimetinib during pregnancy. In animal reproduction studies, oral administration of Cobimetinib in pregnant rats during organogenesis was teratogenic and embryotoxic at exposures (AUC) that were 0.9 to 1.4-times those observed in humans at the recommended human dose of 60 mg. Advise pregnant women of the potential risk to a fetus.
