A Clearinghouse for Information about Blood Clots (DVT/)PE) and Clotting Disorders (thrombophilia) provided as a public service by the University of North Carolina Blood Research Center

Tag: reversal

  • NO FDA Approval Yet for Andexanet

    Stephan Moll, MD writes… The FDA did NOT approve Andexanet (brand names: AndexXa™ in the US, IndexXa™ in Europe) in a decision on August 18th, 2016.  Andexanet is the antidote in clinical development to reverse the anticoagulant effect of Eliquis® (rivaroxaban), Savaysa® (edoxaban), Xarelto® (rivaroxaban) and Lovenox® (enoxaparin).  The FDA is said to have requested more information from…

  • Bleeding on Antithrombotics: Reversal Protocol 2016

    Stephan Moll, MD writes…  Our medical center (University of North Carolina Hospitals,  Chapel Hill)  has put together a comprehensive “Emergent Anticoagulation Reversal Guideline” for our local use, updated since its last edition in 2014 with information about Pradaxa® reversal (with Praxbind®).  It is  a practical, clinical how-to document (2016 PDF here ). Colleagues and hospitals are welcome to take the…

  • Reversal Agent for Pradaxa: Important NEJM Publication Today

    Stephan Moll, MD writes… A publication in the New England Journal of Medicine today reports on the use of the Pradaxa® (Dabigatran) antidote Idarucizumab in patients on Pradaxa® who present with major bleeding or require urgent surgery [ref 1]. 

  • Antidote for New Oral Xa-Inhibitors (Eliquis, Xarelto): Phase 2 Study

    Stephan Moll, MD writes…. The pharmaceutical company Portola reported today (May 8th, 2013) without many details on the  findings of their phase 2 human volunteer study of their anti-Xa anticoagulant antidote PRT4445 — ClinicalTrials.gov Identifier: NCT01758432 (study description here). In this study, healthy volunteers who had taken Eliquis (Apixaban) received the antidote.  The study showed a “rapid and sustained and dose-related reversal of the…

  • Pradaxa – Management of Major Bleeding

    Major and life-threatening bleeding is expected to occur in some patients treated with Pradaxa® (=Dabigatran). The question will then urgently arise how to best treat such catastrophic bleeding.  As there have been no data published on this topic in the peer-reviewed medical literature, we don’t know how to best manage a patient with major and…