Opsumit Use In Pregnancy & Lactation

Use in women of childbearing potential/Contraception in males and females: 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 practised (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.
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).
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 data under Actions). A risk to the breastfeeding child cannot be excluded. Opsumit is contraindicated during breastfeeding (see Contraindications).
Male fertility: The development of testicular tubular atrophy in male animals was observed after treatment with macitentan (see Pharmacology: Toxicology: Preclinical safety data under Actions). Decreases in sperm count have been observed in patients taking ERAs. Macitentan, like other ERAs, may have an adverse effect on spermatogenesis in men.