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Pregnancy: Apixaban is classified as Pregnancy Category B. There are no adequate and well controlled studies of apixaban in pregnant women. Animal studies have not demonstrated any evidence of fetotoxic effects but increased maternal bleeding was observed when apixaban was administered in pregnant animals at dose ranging from 1-19 times the human exposure at the maximum recommended dose. It is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.
Lactation: It is unknown whether apixaban or its metabolites are excreted in human milk. Rats excrete apixaban in their milk. Decision should be made either to discontinue breastfeeding or to discontinue apixaban therapy, taking into account the importance of the drug to the mother.
