Floriva Use In Pregnancy & Lactation

Pregnancy: Safety and efficacy of Rivaroxaban have not been established in pregnant women. 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, Rivaroxaban is contraindicated during pregnancy (see Contraindications).
Women of child bearing potential should avoid becoming pregnant during treatment with rivaroxaban.
Breastfeeding: Safety and efficacy of Rivaroxaban have not been established in breastfeeding women. Data from animals indicate that rivaroxaban is secreted into milk. Therefore Rivaroxaban is contraindicated during breastfeeding (see Contraindications). A decision must be made whether to discontinue breastfeeding 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).