Pregnancy Category: X; consistently shown to have teratogenic effects when administered to animals
In both rabbits and rats, there were cardiovascular and mandibular arch fusion abnormalities; administration to female rats from late pregnancy through lactation caused reduced pup survival and impairment of the male fertility of the offspring at all dose levels tested
Lactation: Unknown if distributed in human breast milk; due to presence of macitentan and metabolites in milk of lactating rats and potential for serious adverse effects in nursing infants, do not recommend use while nursing