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Pregnancy Risk Factor C.
Adverse events have been observed in animal reproduction studies. Based on ex-vivo data, rivaroxaban crosses the placenta. Information related to the use of rivaroxaban during pregnancy and postpartum is limited. Data are insufficient to evaluate the safety of oral factor Xa inhibitors during pregnancy; use during pregnancy should be avoided. Use may increases the risk of pregnancy related hemorrhage.
Safety and efficacy of rivaroxaban have not been established in nursing mothers. In rats rivaroxaban is secrete into breast milk. Therefore rivaroxaban may only be administered after breastfeeding is discontinued.
