Can I take apixaban while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary The limited available data on apixaban tablets use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. Treatment may increase the risk of bleeding during pregnancy and delivery. In animal reproduction studies, no adverse developmental effects were seen when apixaban was administered to rats (orally), rabbits (intravenously) and mice (orally) during organogenesis at unbound apixaban exposure levels up to 4, 1 and 19 times, respectively, the human exposure based on area under plasma-concentration time curve (AUC) at the Maximum Recommended Human Dose (MRHD) of 5 mg twice daily. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): apixaban (oral), Indoco Remedies Limited. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Information from four mothers indicates that apixaban levels in milk are high, potentially resulting in infant anticoagulation and bleeding, which was confirmed with a pharmacokinetic model. An alternate drug is preferred, especially while nursing a newborn or preterm infant.[1-4]

“Summary of Use during Lactation”, LactMed record “Apixaban” (LM1168), quoted verbatim. Everything LactMed reports about Apixaban while breastfeeding.

8.2 Lactation Risk Summary There are no data on the presence of apixaban or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Apixaban and/or its metabolites were present in the milk of rats (see Data). Because human exposure through milk is unknown, breastfeeding is not recommended during treatment with apixaban tablets. Data Animal data Maximal plasma concentrations were observed after 30 minutes following a single oral administration of a 5 mg dose to lactating rats. Maximal milk concentrations were observed 6 hours after dosing. The milk to plasma AUC (0-24) ratio is 30:1 indicating that apixaban can accumulate in milk. The concentrations of apixaban in animal milk does not necessarily predict the concentration of drug in human milk.

Prescribing label, section “8.2 Lactation”: apixaban (oral), Indoco Remedies Limited. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.