Adempas Use In Pregnancy & Lactation

Women of childbearing potential / Contraception: Women of childbearing potential must use effective contraception during treatment with Adempas.
Pregnancy: There are no data from the use of riociguat in pregnant women. Studies in animals have shown reproductive toxicity and placental transfer (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, Adempas is contraindicated during pregnancy (see Contraindications). Monthly pregnancy tests are recommended.
Breast-feeding: No data on the use of riociguat in breast-feeding women are available. Data from animals indicate that riociguat is excreted into milk. Due to the potential for serious adverse reactions in breast-fed infants Adempas should not be used during breast-feeding. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued during treatment with this medicinal product.
Fertility: No specific studies with riociguat in humans have been conducted to evaluate effects on fertility. In a reproduction toxicity study in rats, decreased testes weights were seen, but there were no effects on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions). The relevance of this finding for humans is unknown.