Lixiana Use In Pregnancy & Lactation

Woman of childbearing potential: Women of childbearing potential should avoid becoming pregnant during treatment with edoxaban.
Pregnancy: Safety and efficacy of edoxaban 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 edoxaban passes the placenta, Lixiana is contraindicated during pregnancy (see Contraindications).
Breast-feeding: Safety and efficacy of edoxaban have not been established in breast-feeding women. Data from animals indicate that edoxaban is secreted into breast milk. Therefore Lixiana is contraindicated during breast-feeding (see Contraindications). A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy.
Fertility: No specific studies with edoxaban 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).