Rhea Rivaroxaban Use In Pregnancy & Lactation

Women of childbearing potential/Contraception: Rivaroxaban should be used in women of childbearing potential only with effective contraception.
Pregnancy: Safety and efficacy of Rivaroxaban 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 (see Pharmacology: Toxicology: Preclinical safety data under Actions). No primary teratogenic potential was identified. Due to the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, Rivaroxaban is contraindicated in pregnancy (see Contraindications, Pharmacology: Toxicology: Preclinical safety data under Actions).
Lactation: Safety and efficacy of Rivaroxaban have not been established in nursing mothers. In rats rivaroxaban is secreted into breast milk.
Therefore Rivaroxaban may only be administered after breastfeeding is discontinued (see Contraindications, Pharmacology: Toxicology: Preclinical safety data under Actions).