There are no data from the use of ELIQUIS in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
ELIQUIS is not recommended during pregnancy.
It is unknown whether ELIQUIS or its metabolites are excreted in human milk. Available data in animals have shown excretion of ELIQUIS in milk. In rat milk, a high milk-to-maternal-plasma ratio (Cmax about 8, AUC about 30) was found, possibly due to active transport into the milk. A risk to newborns and infants cannot be excluded.
A decision must be made to either discontinue breastfeeding or to discontinue / abstain from ELIQUIS therapy.
Studies in animals dosed with ELIQUIS have shown no effect on fertility.