Uptravi

Uptravi Use In Pregnancy & Lactation

selexipag

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Full Prescribing Info
Use In Pregnancy & Lactation
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 Pharmacology: Toxicology 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 Pharmacology: Toxicology under Actions). A risk to the suckling child cannot be excluded. Uptravi should not be used during breast-feeding.
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