Opsumit Use In Pregnancy & Lactation

Pregnancy: There are no data on the use of macitentan in pregnant women. Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is still unknown. Opsumit is contraindicated during pregnancy and in women of childbearing potential who are not using reliable contraception (see Contraindications).
Use in women of childbearing potential: Opsumit treatment should only be initiated in women of childbearing potential when the absence of pregnancy has been verified, appropriate advice on contraception provided, and reliable contraception is practiced (see Contraindications and Precautions). Women should not become pregnant for 1 month after discontinuation of Opsumit. Monthly pregnancy tests during treatment with Opsumit are recommended to allow the early detection of pregnancy.
Breastfeeding: It is not known whether macitentan is excreted into human breast milk. In rats, macitentan and its metabolites are excreted into milk during lactation (see Pharmacology: Toxicology: Preclinical safety date under Actions). A risk to the breastfeeding child cannot be excluded. Opsumit is contraindicated during breastfeeding (see Contraindications).