Dabigatran and Breastfeeding

Summary of use during lactation

In adults, less than 7% of dabigatran is absorbed orally in its prodrug form of dabigatran etexilate mesylate; dabigatran itself is not absorbed orally. Preliminary data from 2 individuals indicate that dabigatran is poorly excreted into breastmilk and unlikely to affect the breastfed infant. If the mother requires dabigatran, it is not a reason to discontinue breastfeeding. Because data are limited, monitor preterm or newborn infants for signs of bleeding.[1,2]

Drug levels in milk and infant serum

Maternal Levels. In preliminary results from a study on dabigatran in breastmilk, two patients received oral dabigatran etexilate 220 mg (2.5 and 2.7 mg/kg dabigatran). Dabigatran was first detectable in milk 2 to 3 hours after the dose. Peak milk levels occurred at 7 hours after the dose. Milk concentrations at this time were 8.2 mcg/L and 52.6 mcg/L, respectively. Average maximum estimated daily infant dosages on day 5 postpartum were 0.35 and 2.7 mcg/kg, respectively. These values corresponded to weight-adjusted dosages of 0.01 and 0.07% of the maternal dosage. On days 1 and 3 postpartum, estimated dosages were somewhat less.[1] A preliminary physiologically based pharmacokinetic model was validated using these patients’ data predicted a steady-state RID of 0.013% with a daily dose of 220 mg of dabigatran etexilate mesylate.[3] Infant Levels. Measurements of dabigatran in infant plasma after breastfeeding have not been made. However, based on data from 2 infants and assuming complete dabigatran absorption by the infant, investigators estimated that infant plasma levels would be less than 0.1 ng/L on days 1, 3 and 5 postpartum with a daily maternal dosage of 220 mg of dabigatran etexilate mesylate.[1]

Effects in breastfed infants

Samples of newborn and preterm infant blood spiked with of dabigatran in the concentrations found in breastmilk after a 220 mg dose of dabigatran etexilate indicate that no effect on coagulation would occur.[1]

Effects on lactation and breastmilk

Relevant published information was not found as of the revision date.

Alternative drugs to consider

Acenocoumarol, Dalteparin, Enoxaparin, Heparin, Rivaroxaban, Warfarin

References

1. Ayuk P, Kampouraki E, Truemann A, et al. Investigation of dabigatran secretion into breast milk: Implications for oral thromboprophylaxis in post-partum women. Am J Hematol 2020;95:E10–E3.31599003 PubMed
2. Daei M, Khalili H, Heidari Z. Direct oral anticoagulant safety during breastfeeding: A narrative review. Eur J Clin Pharmacol 2021;77:1465–71.33963877 PubMed
3. Ogungbenro K, Aucott L, Kamali F, et al. Translation of a physiologically-based pharmacokinetic model for dabigatran etexilate to the design of a safety and efficacy study in post-partum women. Br J Clin Pharmacol 202541273069 PubMed