Last update May 14, 2021

Dabigatran etexilate

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

An oral thrombin inhibitor. It belongs to the group of so-called non–vitamin K oral anticoagulants (NOACs) or direct anticoagulants.
Used in the prevention of venous thromboembolism in orthopedic surgery and atrial fibrillation.
Oral administration in a daily dose.

It is excreted in breastmilk in clinically insignificant amounts (Ayuk 2020 & 2016).

Its low oral bioavailability (EMA 2018, Blech 2008) hinders transfer to infant plasma via breastmilk, except in premature infants and the immediate neonatal period when there may be increased intestinal permeability.

It is the oral anticoagulant with the lowest excretion in breast milk (Daei 2021).

Alternatives

  • Acenocoumarol ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Dalteparin Sodium ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Enoxaparin Sodium ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Heparin ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Warfarin ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Dabigatran etexilate is also known as


Dabigatran etexilate in other languages or writings:

Tradenames

Main tradenames from several countries containing Dabigatran etexilate in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 3 - 7.2 %
Molecular weight 628 daltons
Protein Binding 35 %
VD 0.9 - 1 l/Kg
pKa 3.2 -
Tmax 0.5 - 2 hours
8 - 14 hours
M/P ratio 0.04 - 0.13 -
Theoretical Dose 0.001 - 0.008 mg/Kg/d
Relative Dose 0.05 - 0.32 %

References

  1. Azenkot T, Schwarz EB. Special Considerations for Women of Reproductive Age on Anticoagulation. J Gen Intern Med. 2022 Aug;37(11):2803-2810. Abstract Full text (link to original source)
  2. Daei M, Khalili H, Heidari Z. Direct oral anticoagulant safety during breastfeeding: a narrative review. Eur J Clin Pharmacol. 2021 May 8. Abstract
  3. Ayuk P, Kampouraki E, Truemann A, Sidgwick F, McDonald L, Bingham J, Murphy P, Kamali F. Investigation of dabigatran secretion into breast milk: Implications for oral thromboprophylaxis in post-partum women. Am J Hematol. 2020 Jan;95(1):E10-E13. Abstract
  4. EMA-Boehringer. Dabigatran. Drug Summary. 2018 Full text (in our servers)
  5. EMA-Boehringer. Dabigatran. Ficha técnica. 2018 Full text (in our servers)
  6. Cohen H, Arachchillage DR, Beyer-Westendorf J, Middeldorp S, Kadir RA. Direct Oral Anticoagulants and Women. Semin Thromb Hemost. 2016 Oct;42(7):789-797. Epub 2016 Oct 5. Review. Abstract
  7. Ayuk P, Walker J. An Open Label, Non-Randomised, Phase II study to Determine if Dabigatran and its Metabolites are Detectable in Breast Milk Following Oral Administration to Non-Breastfeeding Mothers. EMA. Clinical trial results. 2016 Full text (link to original source) Full text (in our servers)
  8. Blech S, Ebner T, Ludwig-Schwellinger E, Stangier J, Roth W. The metabolism and disposition of the oral direct thrombin inhibitor, dabigatran, in humans. Drug Metab Dispos. 2008 Feb;36(2):386-99. Epub 2007 Nov 15. Abstract

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