<p>Based on its mechanism of action and findings in animals, Ponatinib can cause fetal harm when administered to a pregnant woman. There are no available data on Ponatinib use in pregnant women. In animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at doses lower than human exposures at the recommended human dose. Advise pregnant women of the potential risk to a fetus.<br />
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There is no data on the presence of ponatinib in human milk, the effects on the breastfed infant or on milk production.</p>