Is Bosentan compatible with breastfeeding? Do we have alternatives for Bosentan?

Bosentan

September 28, 2015 (Low Risk)

Indicated for the treatment of pulmonary arterial hypertension.

Pharmacokinetic data (moderately high molecular weight and high percentage of protein binding capacity) 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.

It is approved for Pediatric use from 1-year-old or 10 kg to higher, but there are not published data on neonatal indication.

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.

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

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

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Writings

  • Βοζεντάνη (Greek)
  • بوزانتان (Arabic)
  • Бозентан (Cyrillic)
  • 波生坦 (Chinese)
  • ボセンタン (Japanese)
  • C27 H29 N5 O6 S (Molecular formula)

Drug trade names

References

  1. Pediamécum (AEP). Bosentan. Ficha técnica. 2014 Full text (link to original source) Full text (in our servers)
  2. AEMPS. Bosentan. Ficha técnica. 2013 Full text (in our servers)
  3. Nakwan N, Choksuchat D, Saksawad R, Thammachote P, Nakwan N. Successful treatment of persistent pulmonary hypertension of the newborn with bosentan. Acta Paediatr. 2009Abstract
  4. 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. 2008Abstract
  5. Maiya S, Hislop AA, Flynn Y, Haworth SG. Response to bosentan in children with pulmonary hypertension. Heart. 2006Abstract
  6. 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. 2005Abstract
  7. 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. 2005Abstract
  8. Dingemanse J, van Giersbergen PL. Clinical pharmacology of bosentan, a dual endothelin receptor antagonist. Clin Pharmacokinet. 2004Abstract
  9. 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. 2003Abstract