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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.  For a Clot Connect discussion of the DVT and PE treatment studies – called the EINSTEIN program – and their publication [ref 1] see here.  The same Xaelto dose (20 mg qd) that is now FDA approved for atrial fibrillation is the dose that was studied in the secondary VTE prevention trial [ref 1].

Would I prescribe Xarelto® off label for patients with DVT and PE, even though it is not yet FDA approved for that indication? I would not rush into it, but would prefer to wait to see what FDA decides on the DVT and PE indication, after review of all the DVT and PE data. However, if a patient poorly tolerates warfarin, has very fluctuating INRs, has a strong preference to switch away from warfarin, I would discuss  a switch to Pradaxa® (Dabigatran) or Xarelto® (Rivaroxaban) even now.  And,  if the patient is fully educated about the drugs, understands that we would be using them in a non-FDA approved indication, and still wants to change, I would consider prescribing one of them for DVT and/or PE. However, my general preference would be to see clinical experience with the drugs gained in the approved indication, before I would use them off label.  Based on the good DVT and PE phase 3 study data with both drugs, I expect that they will also soon be approved for DVT and PE treatment. Thus, they may be available for DVT and PE treatment within a year or so.


1.  EINSTEIN investigators. Oral Rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-2510.

Disclosures: I have consulted for OthoMcNeil and Bayer, the companies developing Xarelto.

Last updated: Nov 4th, 2011

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