Patient Education Blog

Xarelto (Rivaroxaban) – FDA Approved

On July 1st, the FDA approved the oral blood thinner Xarelto (rivaroxaban) for the prevention of deep vein thrombosis (DVT) in patients undergoing  knee or hip replacement surgery.

This is good news, as Xarelto is quite effective and is easy to take. Its advantages over currently used drugs for the prevention of DVT and PE after orthopedic surgeries are:

  • It is an oral drug, whereas the presently often used drugs (Lovenox = Enoxaparin, Fragmin =Dalteparin, and Innohep = Tinzaparin) have to be injected underneath the skin;
  • Its blood thinning effect does not need to be routinely monitored (whereas warfarin, that is also often used, needs to be monitored);
  • Patients can eat what they want, as Xarelto is not influenced by vitamin K in the diet (as opposed to warfarin, which is influenced by vitamin K);
  • Xarelto was found to be more effective in preventing DVTs and PEs than Lovenox = Enoxaparin [ref 1], yet equally safe.

Up until now orthopedic surgeons have recommended to their patients either (a) injections with heparin or low molecular weight heparins (Lovenox = Enoxaparin, Fragmin – Dalteparin, or Innohep = Tinzaparin), (b) warfarin, or (c) the less effective aspirin.  Xarelto is the first one of the new type of oral blood thinners that has now received approval in the U.S. for DVT prevention after orthopedic surgeries.  As the risk of blood clots persists for several weeks after major orthopedic surgery and injections with Lovenox and similar drugs for several weeks can be cumbersome for the patient to take, it is nice to now have an effective oral alternative available.

The FDA announcement can be found here. The company’s Xarelto prescribing information (package insert) can be found here. The approved dose for prevention of DVT is 10 mg once daily.

Other Studies on Xarelto
Xarelto is NOT approved at this point for treatment of DVT, PE or for atrial fibrillation. For a Clot Connect discussion of the DVT and PE treatment studies – called the EINSTEIN trials [ref 2] and publication see here
.

Professional Guidelines

Understandably, neither one of these guidelines take reference to the new oral anticoagulants, as the latest editions of both are from 2008.

  1. American College of Chest Physicians (ACCP):  [Geerts WH et al. Chest 2008;133:381S-453S] – link here New ones are expected to come out at the beginning of 2012.
  2. American Academy of Orthopedic Surgeons (AAOS): Clinical Guideline; Aug 2008 – link here.

Reference

  1. Turpie AG et al. Rivaroxaban for the prevention of venous thromboembolism after hip and knee arthroplasty. Pooled analysis of four studies. Thromb Haemost, 2011;105:444-453.
  2. EINSTEIN investigators. Oral Rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-2510.

 

ADDENDUM

On Nov 4th, 2011 the FDA approved Rivaroxaban for the atrial fibrillation indication – details here.

 

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

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.

Last updated: Nov 4th, 2011

Tags: , , , , ,

2 Responses to “Xarelto (Rivaroxaban) – FDA Approved”

  1. soren says:

    Hooray – good news indeed. I’ve been on warfarin for 7 years. Does this mean I can switch to Xarelto for long-term prevention therapy?

    • Stephan Moll says:

      No. Explanation: There is a difference between primary prevention (prevention of a clot – DVT and PE – in a person who has never had a clot) and secondary prevention (prevention of an additional clot in somebody who has had a previous clot). Typically, for primary prevention a lower dose of a drug is used, whereas for secondary prevention a higher dose is given. In the case of Rivaroxaban: (a) primary DVT prevention dose, as now FDA approved, is 10 mg once daily. The secondary long-term DVT prevention dose, as studied in the so-called EINSTEIN -EXTENSION trial (published: N Engl J Med 2010;363:2499-2510) is 20 mg once daily. That indication and dose is not FDA approved at this point.