Pregnancy: Safety and efficacy of Xarelto have not been established in pregnant women.
Xarelto 10 mg: In rats and rabbits rivaroxaban showed pronounced maternal toxicity with placental changes related to its pharmacological mode of action (eg, hemorrhagic complications) leading to reproductive toxicity. No primary teratogenic potential was identified.
Women of Childbearing Potential/Contraception: Xarelto should be used in women of childbearing potential only with effective contraception.
Xarelto 15 and 20 mg: Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, Xarelto is contraindicated during pregnancy (see Contraindications).
Women of child-bearing potential should avoid becoming pregnant during treatment with rivaroxaban.
Breast feeding: Safety and efficacy of Xarelto have not been established in breast feeding women. Data from animals indicate that rivaroxaban is secreted into breast milk. Therefore, Xarelto is contraindicated during breast feeding (see Contraindications). A decision must be made whether to discontinue breast feeding or to discontinue/abstain from therapy.
Fertility: No specific studies with rivaroxaban in humans have been conducted to evaluate effects on fertility. In a study on male and female fertility in rats no effects were seen (see Pharmacology: Toxicology: Preclinical safety data under Actions).