Bosentan

The Basics

What is Bosentan?

Used to treat pulmonary hypertension.

Brand names for Bosentan

Tracleer

How Bosentan is classified

Antihypertensive Agents

Bosentan During Pregnancy

Bosentan pregnancy category

Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Bosentan while pregnant

Based on data from animal reproduction studies, Tracleer may cause fetal harm, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy . There are limited data on Tracleer use in pregnant women. In animal reproduction studies, oral administration of bosentan to pregnant rats at 2times the maximum recommended human dose (MRHD) on a mg/m2 basis caused teratogenic effects in rats, including malformations of the head, mouth, face, and large blood vessels [see Animal Data]. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Bosentan was teratogenic in rats given oral doses two times the MRHD (on a mg/m2 basis). In an embryo-fetal toxicity study in rats, bosentan showed dose-dependent teratogenic effects, including malformations of the head, mouth, face and large blood vessels. Bosentan increased stillbirths and pup mortality at oral doses 2 and 10 times the MRHD (on a mg/m2 basis). Although birth defects were not observed in rabbits given oral doses of up to the equivalent of 10.5 g/day in a 70 kg person, plasma concentrations of bosentan in rabbits were lower than those reached in the rat. The similarity of malformations induced by bosentan and those observed in endothelin-1 knockout mice and in animals treated with other endothelin receptor antagonists indicates that embryo-fetal toxicity is a class effect of these drugs.

Taking Bosentan While Breastfeeding

What are recommendations for lactation if you're taking Bosentan?

There is little published experience with bosentan during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

There is little published experience with bosentan during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Bosentan on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Bosentan

None listed