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.
Women of childbearing potential: Women of childbearing potential must use effective contraception during treatment with Adempas.
Breast-feeding: No data on the use of riociguat in breast-feeding women are available. Data from animals indicate that riociguat is secreted into milk. Due to the potential for serious adverse reactions in nursing 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 medicine.
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.