[en] Rivaroxaban is one of the new oral anticoagulants (NOACs). It has many potential advantages in comparison with Vitamin K Antagonists (VKA). It has a predictable anticoagulant effect and does not theoretically require biological monitoring. It is also characterized by less food and drug interactions. However, due to major risks associated with over- and under-dosage, its optimal use in patients should be carefully followed by health care professionals. The aim of this article is to provide recommendations for pharmacists on the practical use of Xarelto in its different approved indications. This document is adapted from the practical user guide of rivaroxaban which was developed by an independent group of Belgian experts in the field of thrombosis and haemostasis.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Douxfils, J; Département de pharmacie, Université de Namur, Namur
Michel, S; Université de Namur, Département de Pharmacie, 5000 Namur, Belgium
E.M.A. EPAR - Public Assessment Report for Pradaxa. Accessed on 5th December 2011 Available from: http://www.ema.europa.eu/docs/en-GB/document- library/EPAR---Public-assessment-report/human/000829/WC500041062.pdf.
E.M.A. EPAR - Public Assessment Report for Xarelto. Accessed on 24th August 2012; Available from: http://www.ema.europa.eu/docs/en-GB/document- library/EPAR---Public-assessment-report/human/000944/WC500057122.pdf.
E.M.A. EPAR - Public Assessment Report for Eliquis Accessed on 29th November 2012; Available from: http://www.ema.europa.eu/docs/en-GB/document- library/EPAR---Public-assessment-report/human/002148/WC500107726.pdf.
F.D.A. Approval History for Rivaroxaban. Accessed on 23th November 2011 Available from: http://www.accessdata.fda.gov/drugsatfda-docs/label/2011/ 202439s000lbl.pdf.
Aalbers, J., A. Bryer, and E. Klug, FDA committee unanimously recommends approval of dabigatran etexilate for stroke prevention in atrial fibrillation. Cardiovasc J Afr, 2010. 21(6): p. 341.
Bristol-Myers Squibb. Eliquis (apixaban) receives CHMP positive opinion for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation [press release]. September 21.
Eriksson, B.I., et al., Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med, 2008. 358(26): p. 2765-75. (Pubitemid 351930851)
Kakkar, A.K., et al., 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): p. 31-9.
Lassen, M.R., et al., Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med, 2008. 358(26): p. 2776-86. (Pubitemid 351930852)
Patel, M.R., et al., Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med, 2011. 365(10): p. 883-91.
Bauersachs, R., et al., Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med, 2010. 363(26): p. 2499-510.
E.M.A. Summary of Product Characteristic (SmPC). EU-SmPC dated November 2012.
Kubitza, D., et al., Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor. Clin Pharmacol Ther, 2005. 78(4): p. 412-21. (Pubitemid 41393676)
Kubitza, D., et al., Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects. Curr Med Res Opin, 2008. 24(10): p. 2757-65.
Kubitza, D., et al., Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939, an oral, direct Factor Xa inhibitor, after multiple dosing in healthy male subjects. Eur J Clin Pharmacol, 2005. 61(12): p. 873-80. (Pubitemid 41803696)
Moore KT, e.a., The relative bioavailability of single-dose rivaroxaban, a novel oral anticoagulant and a selective direct factor Xa inhibitor, administered orally (as a whole or crushed tablet) and via nasogastric tube (as a crushed tablet suspension). Pharmacother., 2012. 32(10): p. e185-e186 [abstract 28].
Sie, P., et al., Surgery and invasive procedures in patients on long-term treatment with direct oral anticoagulants: thrombin or factor-Xa inhibitors. Recommendations of the Working Group on Perioperative Haemostasis and the French Study Group on Thrombosis and Haemostasis. Arch Cardiovasc Dis, 2011. 104(12): p. 669-76.
Pernod, G., et al., [Questions -answers on the use of rivaroxaban for the treatment of venous thromboembolic disease.]. J Mal Vasc, 2012.
Spyropoulos, A.C. and J.D. Douketis, How I treat anticoagulated patients undergoing an elective procedure or surgery. Blood, 2012. 120(15): p. 2954-62.
Nutescu, E., I. Chuatrisorn, and E. Hellenbart, Drug and dietary interactions of warfarin and novel oral anticoagulants: an update. J Thromb Thrombolysis, 2011. 31(3): p. 326-43.
Kubitza, D., et al., Effect of food, an antacid, and the H2 antagonist ranitidine on the absorption of BAY 59-7939 (rivaroxaban), an oral, direct factor Xa inhibitor, in healthy subjects. J Clin Pharmacol, 2006. 46(5): p. 549-58.
E.M.A. Summary of Opinion. Accessed on 8th November 2012; Available from: http://www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion/human/ 000944/WC500134094.pdf.
Turpie, A.G., et al., Management consensus guidance for the use of rivaroxaban - an oral, direct factor Xa inhibitor. Thromb Haemost, 2012. 108(5): p. 876-86.
Mismetti, P. and S. Laporte, New oral antithrombotics: a need for laboratory monitoring. For. J Thromb Haemost, 2010. 8(4): p. 621-6.
Bounameaux, H. and G. Reber, New oral antithrombotics: a need for laboratory monitoring. Against. J Thromb Haemost, 2010. 8(4): p. 627-30.
Douxfils, J., et al., Assessment of the impact of rivaroxaban on coagulation assays: Laboratory recommendations for the monitoring of rivaroxaban and review of the literature. Thromb Res, 2012. 130(6): p. 956-66.
Ten Cate, H., Monitoring new oral anticoagulants, managing thrombosis, or both? Thromb Haemost, 2012. 107(5).
Kubitza, D., et al., Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor. Br J Clin Pharmacol, 2010. 70(5): p. 703-12.
Halabi A, K.D., Zuehlsdorf M, Becka M, Mueck W, Maatouk H, Effect of hepatic impairment on the pharmacokinetics, pharmacodynamics and tolerability of rivaroxaban. J Thromb Haemost 2007, 2007. 5 Supplement 2: p. P-M-635.