Last update: May 14, 2021

Rivaroxaban

Very Low Risk for breastfeeding


Safe. Compatible.
Minimal risk for breastfeeding and infant.

Direct factor Xa inhibitor, indicated in the prevention of thromboembolism.
Administered orally every 12 to 24 hours.

Its pharmacokinetic data (large volume of distribution and high percentage of protein binding) explain the very small passage to milk observed in four different cases (Zhao 2020, Muysson 2019, Saito 2019, Wiesen 2016).
No problems were observed in an 18-month-old infant whose mother was treated with rivaroxaban from the first postpartum week (Saito 2019).

Several experts authors and expert consensus, consider the use of this medication to be safe or very probably safe during breastfeeding (LactMed, Hale, Daei 2021, Zhao 2020).

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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

Rivaroxaban in other languages or writings:

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
T1/2 5 - 9 hours
M/P ratio 0,27 - 0,4 -
Theoretical Dose 0,0034 - 0,024 mg/Kg/d
Relative Dose 1,3 - 4,8 %

References

  1. Daei M, Khalili H, Heidari Z. Direct oral anticoagulant safety during breastfeeding: a narrative review. Eur J Clin Pharmacol. 2021 May 8. Abstract
  2. 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
  3. 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
  4. 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
  5. EMA. Rivaroxaban (Xarelto). Drug Summary. 2017 Full text (in our servers)
  6. EMA. Rivaroxabán (Xarelto). Ficha técnica. 2017 Full text (in our servers)
  7. 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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