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Facts About XARELTO®

Renal function information

RENAL IMPAIRMENT

Renal Function (CrCl)

Label Inclusion

Mild (50-79 mL/min)1,2

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Moderate (30-49 mL/min)1,2

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Severe (15-29 mL/min)2

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End-stage renal disease (ESRD) (<15 mL/min)3

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CrCl = creatinine clearance.

Renal dosing considerations

  • Nonvalvular AF: Periodically assess renal function as clinically indicated (ie, more frequently in situations in which renal function may decline) and adjust therapy accordingly. Consider dose adjustment or discontinuation of XARELTO® in patients who develop acute renal failure while on XARELTO®
  • All other indications: Avoid using XARELTO® in patients with CrCl <30 mL/min

Aspects of treatment with XARELTO® and warfarin

XARELTO®
warfarin
 
Mechanism of action
Selective Factor Xa inhibitor
Vitamin K antagonist4
 
Dosing
Fixed (with dose adjustment for renal function to reduce stroke risk in nonvalvular AF)
Must be individualized for each patient according to patient’s INR response to the drug and repeatedly adjusted to remain within the target INR of 2.0 to 3.04
 
Monitoring
No routine coagulation monitoring1,5-10
Daily INR monitoring required after administration of initial dose until stabilized; INR monitoring every 1-4 weeks thereafter, according to clinical situation.4 Data from a meta-analysis* showed that therapeutic INRs are only achieved about half the time.11 In fact, patients average about 17 PT/INR tests per year, with one-third of test results prompting dose adjustments12
 
Dose adjustments
No dose adjustments for age, weight, or gender
Appropriate initial dosing varies widely for different patients. Initial dose is influenced by age, weight, and gender4
 
Dietary restrictions
No known dietary restrictions
Dietary restrictions required. Foods high in vitamin K may alter the effects of warfarin4
 
Costs and resources needed, related to dose adjustment and INR monitoring
Minimal
Yes (lab tests, visits to various HCPs, time to administer those tests, dose adjustment, and co-pay associated with regular INR monitoring)12
 

There are limited data on the relative effectiveness of XARELTO® and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.

*Meta-analysis assessed 8 studies, including a total of 14 groups involving 22,237 warfarin-treated AF patients, with 41,199 years of follow-up. AF patients in the 14 groups spent 55% (95% CI: 51%-58%) of their time within the therapeutic INR range.11

AF = atrial fibrillation; INR = international normalized ratio; PT = prothrombin time.

Differing needs of patients on warfarin and XARELTO®

 

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. Kubitza D, Becka M, Mueck W, et al. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor. Brit J Clin Pharmacol. 2010;70(5):703-712.
  3. Dias C, Moore KT, Murphy J, et al. Pharmacokinetics, pharmacodynamics, and safety of single-dose rivaroxaban in chronic hemodialysis. Am J Nephrol. 2016;43(4):229-236.
  4. Coumadin® (warfarin) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; 2015.
  5. The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-1297.
  6. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510.
  7. Lassen MR, Ageno W, Borris LC, et al; for the RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.
  8. Kakkar AK, Brenner B, Dahl OE, et al; for the RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39.
  9. Eriksson BI, Borris LC, Friedman RJ, et al; for the RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
  10. Mueck W, Eriksson BI, Bauer KA, et al. Population pharmacokinetics and pharmacodynamics of rivaroxaban – an oral, direct Factor Xa inhibitor – in patients undergoing major orthopaedic surgery. Clin Pharmacokinet. 2008;47(3):203-216.
  11. Baker WL, Cios DA, Sander SD, Coleman CI. Meta-analysis to assess the quality of warfarin control in atrial fibrillation patients in the United States. J Manag Care Pharm. 2009;15(3):244-252.
  12. Menzin J, Boulanger L, Hauch O, et al. Quality of anticoagulation control and costs of monitoring warfarin therapy among patients with atrial fibrillation in clinic settings: a multi-site managed-care study. Ann Pharmacother. 2005;39(3):446-451.