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About XARELTO®

Not intended to be a comparison of safety or efficacy outcomes.

NOAC = non-vitamin K antagonist oral anticoagulant.

*Based on the following: CHADS2 scores 3-6 in ROCKET AF (N=12,402), ARISTOTLE (N=5502), AVERROES (N=1570), ENGAGE-AF (N=~11,200), and RE-LY (N=5882); risk factors of DVT, PE, DVT/PE, cancer, elderly, previous VTE, provoked VTE, unprovoked VTE, and recent trauma or surgery in EINSTEIN pooled analysis (N=8281), AMPLIFY (N=5395), Hokusai-VTE (N=8240), and RE-COVER I and II (N=5107); high risk factors associated with knee and/or hip surgery in RECORD1-3 (N=9011), ADVANCE 1-3 (N=11,659), and RE-NOVATE and RE-NOVATE II (N=5428).

 

Indications

 

IMPORTANT SAFETY INFORMATION

 

Indication and Important saftey Information

 

  • Reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). There are limited data on the relative effectiveness of XARELTO® (rivaroxaban) and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.
  • Treatment of deep vein thrombosis (DVT).
  • Treatment of pulmonary embolism (PE).
  • Reduction in the risk of recurrence of DVT and of PE following initial 6 months treatment for DVT and/or PE.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing knee replacement surgery.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing hip replacement surgery.

References:

  1. Data on file. Janssen Pharmaceuticals, Inc. Based on IMS Health Longitudinal Prescription Database (LRx), through December 2016.
  2. Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-891.
  3. Granger CB, Alexander JH, McMurray JJV, et al; for the ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981-992.
  4. Connolly SJ, Ezekowitz MD, Yusuf S, et al; and the RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.
  5. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510.
  6. The EINSTEIN -PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-1297.
  7. Prins MH, Lensing AWA, Bauersachs R, et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN -DVT and PE randomized studies. Thromb J. 2013;11(1):21.
  8. Prins MH, Lensing AWA, Brighton TA, et al. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomized controlled trials. Lancet Haematol. 2014;1(1):e37-e46.
  9. Connolly SJ, Eikelboom J, Joyner C. et al; for the AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011;364(9):806-817.
  10. Agnelli G, Buller HR, Cohen A, et al; for the AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369(9):799-808.
  11. Schulman S, Kearon C, Kakkar AK, et al; for the RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361(24):2342-2352.
  12. Schulman S, Kakkar AK, Goldhaber SZ, et al; for the RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129(7):764-772.
  13. Online supplement to: Schulman S, Kakkar AK, Goldhaber SZ, et al; for the RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129(7):764-772. http://circ.ahajournals.org/content/suppl/2013/12/10/CIRCULATIONAHA.113.004450.DC1/004450_supplemental_material.pdf. Accessed November 14, 2016.
  14. Anderson FA Jr, Spencer FA. Risk factors for venous thromboembolism. Circulation. 2003;107(23)(suppl 1):I9-I16.
  15. Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013;369(15):1406-1415.
  16. Giugliano RP, Ruff CT, Braunwald E, et al; for the ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093-2104.
  17. Online supplement to: Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013;369(15):1406-1415. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1306638/suppl_file/nejmoa1306638_appendix.pdf. Accessed November 14, 2016.
  18. Eliquis® [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; 2016.
  19. Pradaxa® [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2015.
  20. Savaysa® [prescribing information]. Parsippany, NJ: Daiichi Sankyo, Inc.; 2016.
  21. Data on file. Janssen Pharmaceuticals, Inc. Data as of January 2017.