Uptravi Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential should practise effective contraception while taking selexipag.
Pregnancy: There are no data from the use of selexipag in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Selexipag and its main metabolite showed 20- to 80-times lower prostacyclin (IP) receptor potency in vitro for animal species used in reproductive toxicity testing compared to humans. Therefore, safety margins for potential IP receptor-mediated effects on reproduction are accordingly lower than for non-IP-related effects (see Toxicology: Preclinical safety data under Actions).
Uptravi is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether selexipag or its metabolites are excreted in human milk. In rats, selexipag or its metabolites are excreted in milk (see Toxicology: Preclinical safety data under Actions). A risk to the suckling child cannot be excluded. Uptravi should not be used during breast-feeding.
Fertility: There are no clinical data available. In rat studies, selexipag at high doses caused transient disturbances in oestrus cycles that did not affect fertility (see Toxicology: Preclinical safety data under Actions). The relevance for humans is not known.