Today the FDA approved Xarelto (Rivaroxaban) for irregular heart beat (= atrial fibrillation = a. fib). 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 Blood Clots in the Veins (DVT and PE)
Xarelto is also FDA approved (at a dose of 10 mg once daily) for the PREVENTION of DVT and PE after orthopedic surgery (hip and knee replacement; details here). However, it 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. In the DVT and PE trials the same Xarelto dose (20 mg once daily) was used that is now now FDA approved for atrial fibrillation [ref 1], except that for the first 3 weeks in the acute DVT and PE treatment trial a higher dose was used (15 mg twice daily).
Would I now 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, and has been on warfarin for a few weeks or months, 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 Pradaxa® or Xarelto® 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 one of them off label. Based on the good DVT and PE phase 3 study data for 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.
Reference
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
Disclaimer: ClotConnect.org, its contributors, authors, advisors, members and affiliate organizations do not assume any liability for the content of the website, blog and educational materials. Medical information changes rapidly. While information is believed to be correct, no representation is made and no responsibility is assumed for the accuracy of information contained on or available through this website and blog. Information is subject to change without notice.
Clot Connect 