Xarelto (Rivaroxaban) was approved in Europe today (Dec 19th, 2011) for patients with acute DVT. This is good news on the path to have a blood thinner for patients with DVT available that is easier to deal with than Warfarin. Xarelto is not approved at this point for DVT and PE in the U.S. Final evaluation of the recently completed EINSTEIN PE trial is pending. Today’s European approval announcement can be found here.
Would I prescribe Xarelto off label for patients with DVT and PE, even though it is not yet FDA approved for that indication? I do not rush into it, but 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 one of the new oral anticoagualnts, Pradaxa or Xarelto, even now. And, if the patient is fully educated, understands that we would be using the drug in a non-FDA approved indication, and still wants to change, I would consider prescribing it for DVT and/or PE. However, my general preference would be to see clinical experience with the drug gained in the approved indication, before I would use it off label.
Last updated: Dec 19th, 2011