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Women of childbearing potential/Contraception: Xarelto should be used in women of childbearing potential only with effective contraception.
Pregnancy: Safety and efficacy of Xarelto have not been established in pregnant women.
In rats and rabbits rivaroxaban showed pronounced maternal toxicity with placental changes related to its pharmacological mode of action (e.g., hemorrhagic complications) leading to reproductive toxicity. No primary teratogenic potential was identified. Due to the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, Xarelto is contraindicated in pregnancy (see 'Contraindications').
Lactation: Safety and efficacy of Xarelto have not been established in nursing mothers. In rats rivaroxaban is secreted into breast milk.
Therefore Xarelto may only be administered after breastfeeding is discontinued (see 'Contraindications').
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