There are no data for the use of idarucizumab in pregnant women. Reproductive and developmental toxicity studies have not been performed, given the nature and the intended clinical use of the medicinal product. Idarucizumab may be used during pregnancy, if the expected clinical benefit outweighs the potential risks.
It is unknown whether idarucizumab is excreted in human milk.
There are no data on the effect of idarucizumab on fertility.
Not relevant.
In a phase III trial the safety of Praxbind has been evaluated in 503 patients, who had uncontrolled bleeding or required emergency surgery or procedures and were under treatment with dabigatran etexilate, as well as in 224 volunteers in phase I trials.
No adverse reactions have been identified.
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