626
Views
11
CrossRef citations to date
0
Altmetric
Drug Profile

Andexanet alfa for the reversal of anticoagulant activity in patients treated with direct and indirect factor Xa inhibitors

, , , , , , , , , , & show all
Pages 237-245 | Received 27 Jan 2017, Accepted 09 Mar 2017, Published online: 22 Mar 2017

References

  • Huttner HB, Schellinger PD, Hartmann M, et al. Hematoma growth and outcome in treated neurocritical care patients with intracerebral hemorrhage related to oral anticoagulant therapy: comparison of acute treatment strategies using vitamin K, fresh frozen plasma, and prothrombin complex concentrates. Stroke. 2006;37(6):1465–1470.
  • Tazarourte K, Riou B, Tremey B, et al. Guideline-concordant administration of prothrombin complex concentrate and vitamin K is associated with decreased mortality in patients with severe bleeding under vitamin K antagonist treatment (EPAHK study). Crit Care. 2014;18(2):R81.
  • Hanley CM, Kowey PR. Are the novel anticoagulants better than warfarin for patients with atrial fibrillation? J Thorac Dis. 2015;7(2):165–171.
  • Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883–891.
  • Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981–992.
  • Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093–2104.
  • Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139–1151.
  • Kwong LM. Comparative safety and efficacy of antithrombotics in the management of venous thromboembolism after knee or hip replacement surgery: focus on rivaroxaban. Clin Pharmacol. 2013;5:143–148.
  • Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765–2775.
  • Investigators E, Bauersachs R, Berkowitz SD, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499–2510.
  • Cohen AT, Harrington RA, Goldhaber SZ, et al. Extended thromboprophylaxis with betrixaban in acutely ill medical patients. N Engl J Med. 2016;375(6):534–544.
  • Gibson CM, Mehran R, Bode C, et al. Prevention of bleeding in patients with atrial fibrillation undergoing PCI. N Engl J Med. 2016;375(25):2423–2434.
  • Goldhaber SZ, Leizorovicz A, Kakkar AK, et al. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011;365(23):2167–2177.
  • Cohen AT, Spiro TE, Buller HR, et al. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013;368(6):513–523.
  • Mega JL, Braunwald E, Wiviott SD, et al. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012;366(1):9–19.
  • Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955–962.
  • Liew A, O’Donnell M, Douketis J. Comparing mortality in patients with atrial fibrillation who are receiving a direct-acting oral anticoagulant or warfarin: a meta-analysis of randomized trials. J Thromb Haemost. 2014;12(9):1419–1424.
  • Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369(9):799–808.
  • Lu G, DeGuzman FR, Hollenbach SJ, et al. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med. 2013;19(4):446–451.
  • Ghadimi K, Dombrowski KE, Levy JH, et al. Andexanet alfa for the reversal of factor Xa inhibitor related anticoagulation. Expert Rev Hematol. 2016;9(2):115–122.
  • Yeh CH, Fredenburgh JC, Weitz JI. The real decoy: an antidote for factor Xa-directed anticoagulants. Circ Res. 2013;113(8):954–957.
  • Hollenbach S, Tan S, Deguzman F. PRT064445 reverses rivaroxaban induced anticoagulation in a rabbit liver laceration “treatment” model. Eur Heart J. 2013;34:24.
  • Lu G, Deguzman FR, Karbarz MJ, et al. Reversal of rivaroxaban mediated anticoagulation in animal models by a recombinant antidote protein (R-Antidote). Eur Heart J. 2011;PRT064445:640–641.
  • Hollenbach SJ, Lu G, Deguzman F, et al. Bolus administration of PRT064445, a recombinant factor Xa inhibitor antidote, reverses blood loss and PD markers in a rat model following enoxaparin-induced anticoagulation. Poster session presented at: European Society of Cardiology; 2012.
  • Pine P, Hollenbach SJ, DeGuzman F, et al. Andexanet alfa but not four-factor prothrombin complex concentrate reverses rivaroxaban-induced anticoagulation as measured by reduction in blood loss in a rabbit liver laceration model. Poster session presented at: ISTH; 2015.
  • Hollenbach S, Lu G, Tan S. PRT064445 but not recombinant FVIIa reverses rivaroxaban induced anticoagulation as measured by reduction in blood loss in a rabbit liver laceration model. Blood. 2012;120:21.
  • Crowther M, Kitt M, McClure M, et al. Randomized, double-blind, placebo-controlled single ascending dose pharmacokinetic and pharmacodynamic study of PRT064445, a universal antidote for factor Xa inhibitors. Arterioscler Thromb Vasc Biol. 2013;37(1): 33.
  • Crowther ML, Conley P, Leeds P, et al. Reversal of factor Xa inhibitors-induced anticoagulation in healthy subjects by andexanet alfa. Crit Care Med. 2014;42:12.
  • Crowther M, Levy G, Lu G, et al. 2 randomized, double-blind, placebo-controlled trial demonstrating reversal of edoxaban-induced anticoagulation in healthy subjects by andexanet alfa (PRT064445), A universal antidote for factor Xa (fXa) inhibitors. Blood. 2014;124:4269.
  • Crowther M, Kitt M, Lorenz T, et al. A phase 2 randomized, double-blind, placebo-controlled trial of PRT064445, a novel, universal antidote for direct and indirect factor Xa inhibitors. Poster session presented at: ISTH; 2013.
  • Crowther M, Levy G, Lu G. Reversal of enoxaparin-induced anticoagulation in healthy subjects by andexanet alfa (PRT064445), an antidote for direct and indirect fXa inhibitors. J Thromb Haemost. 2014;12:7.
  • Crowther M, Vandana M, Michael K, et al. A phase 2 randomized, double-blind, placebo-controlled trial demonstrating reversal of rivaroxaban-induced anticoagulation in healthy subjects by andexanet alfa (PRT064445), an antidote for fXa inhibitors. Blood. 2013;122(21):3636.
  • Crowther M, Conley P, Hollenbach S, et al. Sustained reversal of apixaban anticoagulation with andexanet alfa using a bolus plus infusion regimen in phase 2 placebo controlled trial. Eur Heart J. 2014;137.
  • Siegal DM, Curnutte JT, Connolly SJ, et al. Andexanet alfa for the reversal of factor Xa inhibitor activity. N Engl J Med. 2015;373(25):2413–2424.
  • Connolly SJ, Milling TJ Jr, Eikelboom JW, et al. Andexanet alfa for acute major bleeding associated with factor Xa inhibitors. N Engl J Med. 2016;375(12):1131–1141.
  • Connolly SJ, Gibson CM, Crowther M. Andexanet alfa for factor Xa inhibitor reversal. N Engl J Med. 2016;375(25):2499–2500.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.