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: Xarelto

  • International Coagulation Meeting (ISTH 2013): Highlights

    Stephan Moll, MD writes…  A major international coagulation conference, the bi-annual meeting of the International Society for Thrombosis and Haemostasis (ISTH; http://www.isth.org), took place in Amsterdam, Holland, from June 29th to July 4th, 2013.  The clinically relevant highlights about thrombosis and anticoagulation are summarized below.

  • Xarelto (Rivaroxaban) – Hospital Guideline

    Stephan Moll, MD writes… Xarelto® is FDA approved for treatment of venous thromboembolism (VTE), prevention of VTE after hip and knee replacement  surgery, and for atrial fibrillation.   A number of practical management questions are encountered by physicians, pharmacists, and other health care professional taking care of patients on Xarelto®, such as (a) dosing in…

  • Xarelto (Rivaroxaban): FDA Approved for DVT and PE Treatment

    Stephan Moll, MD writes… Today is a very exciting day for patients and health care professionals: the oral anticoagulant Xarelto® (rivaroxaban) was FDA approved today (Nov 2nd, 2012) for the use in patients with DVT and PE – for the acute treatment of DVT and PE, as well as for the secondary long-term prevention of…

  • Rivaroxaban (Xarelto) and PE

    Stephan Moll, MD writes… Good news: The large phase 3 clinical trial comparing 3-12 months treatment of Rivaroxaban (Xarelto) with warfarin in patients with newly diagnosed pulmonary embolism was published on 3-26-2012 in the New England Journal of Medicine [reference 1], showing that Rivaroxaban was (a) noninferior to warfarin in its efficacy, (b) caused the…

  • Xarelto and DVT – Approved in Europe

    Xarelto (Rivaroxaban) was approved in Europe today (Dec 19th, 2011) for patients with acute DVT. This is good news

  • Xarelto (Rivaroxaban) Approved For A. Fib

    Today the FDA approved Xarelto (Rivaroxaban) for atrial fibrillation.  The approved dose is 20 mg once daily. The link to the FDA press release is here.  The Xarelto prescribing information can be found here. Xarelto for Venous Thromboembolism Xarelto is NOT approved at this point for treatment of DVT or PE

  • Rivaroxaban (Xarelto): Advisory Board to the FDA Recommends Approval for Atrial Fibrillation

    The external advisory board to the FDA recommended today (Sept 8th, 2011) to approve Rivaroxaban (Xarelto) for the stroke prevention in atrial fibrillation.  More details about the vote can be found here.  Today’s recommendation is contrary to the one given by an internal FDA review committee which had recommended 2 days ago to NOT approve the…

  • Rivaroxaban (Xarelto): FDA Advisory Board Recommends Against Approval for Atrial Fibrillation

    Surprise to many people today:  An FDA staff report released today (Sept 6th, 2011) states that FDA reviewers recommend against the approval of rivaroxaban (Xarelto) for the atrial fibrillation indication.  A detailed discussion with reasons for the recommendation can be found here.  The main reason: It has not been shown that rivaroxaban is as effective as…