Xarelto® (rivaroxaban) Protect what matters most for your eligible cardiovascular patients

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NVAF Patients

Footnotes

NVAF, non-valvular atrial fibrillation; DOAC, direct oral anticoagulant.
* Rivaroxaban is to be used with caution in patients with CrCl 15 - 29 ml/min and in patients with renal impairment concomitantly recieving other medicinal products which increase rivaroxaban plasma concentrations. Use is not recommended in patients with CrCl < 15 ml/min¹.
** based on prospective real-world evidence where elderly is defined as 80 years or older, SAFIR-AC. Results of ROCKET-AF elderly patient sub-analysis were consistent with overall ROCKET-AF study^5,6.
† The primary efficacy outcome (symptomatic recurrent VTE) occurred in 86 (2.1%) rivaroxaban-treated patients compared with 95 (2.3%) standard therapy-treated patients (hazard ratio, 0.89; 95% confidence interval [CI], 0.66-1.19; Pnon-inferiority, 0.001). Major bleeding occurred in 40 (1.0%) rivaroxaban-treated patients compared with 72 (1.7%) standard therapy-treated patients (hazard ratio, 0.54; 95% CI, 0.37-0.79; p=0.002)⁴.
‡ Primary efficacy outcome (composite of symptomatic VTE and unexplained death for which PE cannot be ruled out): Xarelto 10mg OD vs aspirin 100mg OD, p<0.001; RRR 74% (HR: 0.26; 95% CI: 0.14-0.47); ARR 3.2%. Xarelto 20mg OD vs aspirin 100mg OD, p<0.001; RRR 66% (HR: 0.34; 95% CI: 0.20-0.59); ARR:2.9%. Rates of major bleeding: Xarelto 20mg OD, 0.5%; Xarelto 10mg OD, 0.4%; aspirin 100mg OD, 0.3%⁷.

Use of rivaroxaban is not recommended in those with end stage renal impairment (creatinine clearance <15mL/min). Rivaroxaban can be used in those with a creatinine clearance 15–29 mL/min, provided it is done with caution. Rivaroxaban should also be used with caution in patients with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations.

References

1. Xarelto (rivaroxaban) Summary of Product Characteristics, UK.
2. Prins MH, et al. Thrombosis Journal 2013;11(21):1–10.
3. Weitz JI, et al. N Engl J Med 2017;376:1211-222.
4. Prins MH et al. Thromb J. 2013;11(1):21.
5. Hanon O et al, Heart 2021;107:1376–1382
6. Patel M.R. et al, N Engl J Med. 2011;365:10
7. Weitz J.I., et al, N Engl J Med. 2017; 376:13

PP-XAR-GB-3601 | February 2024