Winrevair Use In Pregnancy & Lactation

Women of childbearing potential: Pregnancy testing is recommended for women of childbearing potential before starting treatment. Women of childbearing potential should use effective contraception during treatment and for at least 4 months after the last dose if treatment is discontinued (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Pregnancy: There are no data from the use of sotatercept in pregnant women. Studies in animals have shown reproductive toxicity (increases in post-implantation losses, reduction in foetal body weights, and delays in ossification) (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Winrevair is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether sotatercept/metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded.
Breast-feeding should be discontinued during treatment and for 4 months after the last dose of treatment.
Fertility: Based on findings in animals, sotatercept may impair female and male fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).