Pregnancy: No clinical study has been conducted in pregnant or lactating women. Limited clinical data on exposure to BRILINTA during pregnancy are available.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition, or postnatal development.
Because animal reproduction studies are not always predictive of a human response, ticagrelor should be used during pregnancy only if the potential benefit to the mother justifies any potential risks to the foetus.
Lactation: It is not known whether this medicinal product is excreted in human milk. Studies in rats have shown that ticagrelor and active metabolites are excreted in the milk. The use of BRILINTA during breastfeeding is not recommended.