Last update: May 4, 2021
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.
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.
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Thank you for helping to protect and promote breastfeeding.
e-lactancia is a resource recommended by Asociación Española de Bancos de Leche Humana from Spain
Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM