Last update Dec. 4, 2024

Rivaroxaban

Compatible

Safe product and/or breastfeeding is the best option.

Direct inhibitor of factor Xa, indicated for the prevention of thromboembolism. Oral administration every 12 to 24 hours.

Its pharmacokinetic data (large volume of distribution and high percentage of protein binding) explain the minimal passage into milk that has been repeatedly observed. (Yamashita 2024, Zhao 2020, Muysson 2020, Saito 2019, Wiesen 2016)

No clinical or hematologic problems were observed in infants of rivaroxaban-treated mothers from the first postpartum week. (Yamashita 2024, Saito 2019)

Plasma levels in these infants were below the limit of detection. (Yamashita 2024)

Several experts and expert consensus consider safe or very likely safe the use of this medication during breastfeeding. (Yamashita 2024, LactMed, Hale, Daei 2021, Zhao 2020)

Alternatives

  • Acenocoumarol (Safe product and/or breastfeeding is the best option.)
  • Dabigatran etexilate (Safe product and/or breastfeeding is the best option.)
  • Dalteparin Sodium (Safe product and/or breastfeeding is the best option.)
  • Enoxaparin Sodium (Safe product and/or breastfeeding is the best option.)
  • Heparin (Safe product and/or breastfeeding is the best option.)
  • Warfarin (Safe product and/or breastfeeding is the best option.)

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

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Other names

Rivaroxaban in other languages or writings:

Groups

Rivaroxaban belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Rivaroxaban in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 80 - 100 %
Molecular weight 436 daltons
Protein Binding 92 - 95 %
VD 0.7 l/Kg
pKa 13.6 -
Tmax 2 - 4 hours
T½ 5 - 9 hours
M/P ratio 0.27 - 0.4 -
Theoretical Dose 0.0034 - 0.024 mg/Kg/d
Relative Dose 0.8 - 3.8 %

References

  1. Yamashita Y, Hira D, Morita M, Katsube Y, Takakura M, Tomotaki H, Tomotaki S, Xiong W, Shiomi H, Horie T, Ueshima S, Mizuno T, Terada T, Ono K. Potential treatment option of rivaroxaban for breastfeeding women: A case series. Thromb Res. 2024 May;237:141-144. Abstract
  2. 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)
  3. Daei M, Khalili H, Heidari Z. Direct oral anticoagulant safety during breastfeeding: a narrative review. Eur J Clin Pharmacol. 2021 May 8. Abstract
  4. Muysson M, Marshall K, Datta P, Rewers-Felkins K, Baker T, Hale TW. Rivaroxaban Treatment in Two Breastfeeding Mothers: A Case Series. Breastfeed Med. 2020 Jan;15(1):41-43. Abstract
  5. Zhao Y, Arya R, Couchman L, Patel JP. Are apixaban and rivaroxaban distributed into human breast milk to clinically relevant concentrations? Blood. 2020 Oct 8;136(15):1783-1785. Abstract
  6. Saito J, Kaneko K, Yakuwa N, Kawasaki H, Yamatani A, Murashima A. Rivaroxaban Concentration in Breast Milk During Breastfeeding: A Case Study. Breastfeed Med. 2019 Dec;14(10):748-751. Abstract
  7. EMA. Rivaroxaban (Xarelto). Drug Summary. 2017 Full text (in our servers)
  8. EMA. Rivaroxabán (Xarelto). Ficha técnica. 2017 Full text (in our servers)
  9. Wiesen MH, Blaich C, Müller C, Streichert T, Pfister R, Michels G. The Direct Factor Xa Inhibitor Rivaroxaban Passes Into Human Breast Milk. Chest. 2016 Jul;150(1):e1-4. Abstract Full text (link to original source) Full text (in our servers)

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