Boehringer Ingelheim announced the authorization of Idarucizumab in Russia. This is a specific antagonist of oral anticoagulant Dabigatran (Pradax)
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Idarucizumab is intended for patients taking Dabigatran when a quick elimination of the anticoagulant effect is required, including when emergency surgery is necessary and for life-threatening or uncontrolled bleeding.
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The drug was approved on the base of the results of the Phase III study RE-VERSE AD.
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The study showed that the antidote immediately and completely eliminates anticoagulant effect of Dabigatran in the vast majority of patients. The median time to perform surgery or emergency procedure was 1.6 hours.
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In 93.4% of cases, researchers rated perioperative hemostasis as normal. The median time to stop bleeding was 2.5 hours.
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Idarucizumab is a Fab fragment of a human monoclonal antibody that binds to Dabigatran with high affinity, which is approximately 300 times more than the binding ability of Dabigatran to thrombin.
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The binding of Idarucizumab to Dabigatran allows you to quickly and steadily neutralize the anticoagulant effect of the latter, and Idarucizumab does not have its own procoagulant effects.
Link: chemrar.ru
