Last update: May 4, 2021

Bosentan

Low Risk for breastfeeding


Moderately safe. Probably compatible.
Mild risk possible. Follow up recommended.
Read the Comment.

It is an antagonist of endothelin receptors.
Indicated in the treatment of pulmonary arterial hypertension, idiopatic or associated with connective tissue disease or heart disease.
Oral administration twice a day.

Since the last update we have not found published data on its excretion in breast milk.

Pharmacokinetic data (moderately high molecular weight, high percentage of protein binding, high volume of distribution and acid pKa) make it unlikely a milk passage in significant amounts.

Low oral bioavailability hinders its passage from the ingested milk to infant's plasma, except in preterm and immediate neonatal period that may show an increased intestinal permeability.

Although no samples have been taken to analyze the concentration in breast milk, a 30 weeks old premature infant who was breastfed for 2-and-a-half months, while his mother was treated with Bosentan and Sildenafil, did not present side-effects (Molelekwa 2005).

It is approved for Pediatric use from 1-year-old or 10 kg to higher, and there are published data on neonatal indication with very good tolerance (Fatima 2018, Pediamecum 2014, Nakwan 2009, Maingourd 2008, Maiya 2006, Rosenzweig 2005, Molelekwa 2005, Barst 2003).

It would be preferred a safer alternative until more data is available about this drug regarding breastfeeding, especially during the neonatal period and in case of prematurity.

Alternatives

We do not have alternatives for Bosentan.

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

Bosentan in other languages or writings:

Tradenames

Main tradenames from several countries containing Bosentan in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 50 %
Molecular weight 552 daltons
Protein Binding 98 %
VD 0,26 l/Kg
Tmax 3 - 5 hours
T1/2 5 hours

References

  1. Fatima N, Arshad S, Quddusi AI, Rehman A, Nadeem A, Iqbal I. Comparison Of The Efficacy Of Sildenafil Alone Versus Sildenafil Plus Bosentan In Newborns With Persistent Pulmonary Hypertension. J Ayub Med Coll Abbottabad. 2018 Jul-Sep;30(3):333-336. Abstract
  2. Pediamécum (AEP). Bosentan. Ficha técnica. 2014 Full text (link to original source) Full text (in our servers)
  3. AEMPS. Bosentan. Ficha técnica. 2013 Full text (in our servers)
  4. Nakwan N, Choksuchat D, Saksawad R, Thammachote P, Nakwan N. Successful treatment of persistent pulmonary hypertension of the newborn with bosentan. Acta Paediatr. 2009 Abstract
  5. Goissen C, Ghyselen L, Tourneux P, Krim G, Storme L, Bou P, Maingourd Y. Persistent pulmonary hypertension of the newborn with transposition of the great arteries: successful treatment with bosentan. Eur J Pediatr. 2008 Abstract
  6. Maiya S, Hislop AA, Flynn Y, Haworth SG. Response to bosentan in children with pulmonary hypertension. Heart. 2006 Abstract
  7. Molelekwa V, Akhter P, McKenna P, Bowen M, Walsh K. Eisenmenger's syndrome in a 27 week pregnancy--management with bosentan and sildenafil. Ir Med J. 2005 Abstract
  8. Rosenzweig EB, Ivy DD, Widlitz A, Doran A, Claussen LR, Yung D, Abman SH, Morganti A, Nguyen N, Barst RJ. Effects of long-term bosentan in children with pulmonary arterial hypertension. J Am Coll Cardiol. 2005 Abstract
  9. Dingemanse J, van Giersbergen PL. Clinical pharmacology of bosentan, a dual endothelin receptor antagonist. Clin Pharmacokinet. 2004 Abstract
  10. Barst RJ, Ivy D, Dingemanse J, Widlitz A, Schmitt K, Doran A, Bingaman D, Nguyen N, Gaitonde M, van Giersbergen PL. Pharmacokinetics, safety, and efficacy of bosentan in pediatric patients with pulmonary arterial hypertension. Clin Pharmacol Ther. 2003 Abstract

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