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Proven Safety Profile in Nonvalvular AF

The safety of XARELTO® taken once daily with the evening meal was evaluated in ROCKET AF, the pivotal trial of more than 14,000 nonvalvular AF patients with prior stroke or multiple comorbidities. XARELTO® demonstrated major bleed rates comparable to warfarin.

Patient Characteristics in ROCKET AF1,2

ROCKET AF studied Xarelto in patients with prior stroke or multiple comorbidities

In subgroup analyses, the bleeding outcomes of XARELTO® in patients with moderate renal impairment, those with prior stroke or TIA, those with heart failure, patients ≥75 years of age, and those with diabetes were generally consistent with the overall trial.3-8

Overall major bleed rates versus warfarin: XARELTO® 3.6, warfarin 3.5 per 100 patient-years

Overall major bleed rates vs warfarin: XARELTO® 3.6, warfarin 3.5 per 100 patient-years Overall major bleed rates vs warfarin: XARELTO® 3.6, warfarin 3.5 per 100 patient-years
  • Lower rate of most concerning bleeds: fatal and ICH1

  • Higher GI bleeds with XARELTO® versus warfarin

    • No difference in fatal GI bleeds versus warfarin7

XARELTO® in patients with moderate renal impairment

Safety generally consistent with the overall trial

21% (n=2950/14,264) of patients in ROCKET AF had moderate renal impairment (CrCl 30 to 49 mL/min) with a median age of 79 years and a 3.7 mean CHADS2 score3
Side effects occurring with XARELTO® in patients with moderate renal impairment, consistent with overall trial Side effects occurring with XARELTO® in patients with moderate renal impairment, consistent with overall trial
  • Safety results in patients with moderate renal impairment (CrCl 30 to 49 mL/min) receiving XARELTO® 15 mg once daily were consistent with those with better renal function (CrCl ≥50 mL/min) given XARELTO® 20 mg once daily, and generally consistent with the overall trial3

  • In patients with moderate renal impairment3:

    • Lower rate of fatal bleeding, including ICH, with XARELTO® versus warfarin

    • Higher GI bleeds with XARELTO® versus warfarin

    • Increased risk for thrombotic events (ie, stroke and systemic embolism) and bleeding in both XARELTO® and warfarin groups

XARELTO® in patients with prior stroke or TIA

Safety generally consistent with the overall trial

55% (n=7811/14,264) of patients in ROCKET AF had prior stroke, TIA, or non-CNS systemic embolism1
Side effects occurring with XARELTO® in patients with prior stroke or TIA, consistent with overall trial Side effects occurring with XARELTO® in patients with prior stroke or TIA, consistent with overall trial
  • Safety results in patients with prior stroke or TIA were consistent with those without prior stroke or TIA, and generally consistent with the overall trial4

XARELTO® in patients with heart failure

Safety generally consistent with the overall trial

64% (n=9033/14,171) of patients in ROCKET AF had CHF or LVEF <40%††5,7
Side effects occurring with XARELTO® in patients with heart failure, consistent with overall trial Side effects occurring with XARELTO® in patients with heart failure, consistent with overall trial
  • Safety results in patients with heart failure were consistent with those without heart failure, and generally consistent with the overall trial5,7

CHF = congestive heart failure; CNS = central nervous system; CrCl = creatinine clearance; EF = ejection fraction; GI = gastrointestinal; HF = heart failure; ICH = intracranial hemorrhage; LVEF = left ventricular ejection fraction; TIA = transient ischemic attack.

††Although the original ROCKET AF study classified patients with EF <35% as having HF, in this subanalysis EF was changed to <40% to be in line with the definition of systolic HF used in many randomized trials.

XARELTO® in patients ≥75 years of age

Safety generally consistent with the overall trial

44% (n=6229/14,264) of patients in ROCKET AF were ≥75 years of age6
Side effects occurring with XARELTO® in patients with prior stroke or TIA, consistent with overall trial Side effects occurring with XARELTO® in patients with prior stroke or TIA, consistent with overall trial
  • Patients aged ≥75 years had higher bleed rates than those <75 years of age6

  • Safety results with XARELTO® versus warfarin did not differ with patient age, and were generally consistent with the overall trial6

    • In patients aged ≥75 years, XARELTO® had higher rates of major + clinically relevant nonmajor bleeding versus warfarin. This was primarily driven by higher GI bleeds (XARELTO® 2.81 vs warfarin 1.66; P=0.0002), consistent with the overall trial6

XARELTO® in patients with diabetes

Safety generally consistent with the overall trial

40% (n=5695/14,264) of patients in ROCKET AF had diabetes8

 

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. 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.
  2. Online supplement to: 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. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1009638/suppl_file/nejmoa1009638_appendix.pdf. Accessed October 15, 2015.
  3. Fox KAA, Piccini JP, Wojdyla D, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J. 2011;32(19):2387-2394.
  4. Hankey GJ, Patel MR, Stevens SR, et al, for the ROCKET AF Steering Committee and Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012;11(4):315-322.
  5. van Diepen S, Hellkamp AS, Patel MR, et al. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013;6(4):740-747.
  6. Halperin JL, Hankey GJ, Wojdyla DM, et al; on behalf of the ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Circulation. 2014;130(2):138-146.
  7. Data on file. Janssen Pharmaceuticals, Inc.
  8. Bansilal S, Bloomgarden Z, Halperin JL, et al. Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: The ROCKET AF trial.Am Heart J. 2015;170(4):675-682.e8.
  9. The Executive Steering Committee, on behalf of the ROCKET AF Study Investigators. Rivaroxaban—Once daily, oral, direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010;159(3):340-347.e1.