Reversal of anticoagulation

An increased risk of bleeding is a known possible complication of all anticoagulant treatments, including warfarin and non-vitamin K antagonist oral anticoagulants (NOACs).1 Although physicians are equipped with a range of clinical measures to manage bleeding complications, a specific reversal agent to dabigatran provides an important therapeutic addition for patient management in rare critical care situations when urgent reversal of the anticoagulant effect of dabigatran is required.2,3

Praxbind® is the first specific reversal agent for a NOAC to receive EU and U.S. approval.4,5 While it is anticipated that Praxbind® will be rarely used in clinical practice, the availability of a specific reversal agent will allow physicians to immediately stop the anticoagulant effect of dabigatran within minutes, in situations where speed matters.6,7

Dabigatran as effective as warfarin with less serious bleeding

Anticoagulant treatment is essential to protect patients with atrial fibrillation against stroke, and for the treatment and prevention of venous thromboembolism.8-10 NOAC innovation has led to better efficacy, safety and convenience compared with oral anticoagulation with warfarin, and guidelines state that when oral anticoagulant treatment is recommended, NOACs should be considered in preference to warfarin.11 Even in the absence of a specific reversal agent, dabigatran has shown a favourable safety and efficacy profile during its extensive clinical trial programme and real-world evaluations.12-22

Emergency situations

Though rare in clinical practice, there will be some situations when urgent reversal of anticoagulation is medically necessary. For example in patients requiring urgent procedures / emergency surgery or patients with life threatening or uncontrolled bleeding. The availability of an immediate reversal option provides an important therapeutic alternative for physicians in these rare emergency situations.

Advancing anticoagulation care

The availability of Praxbind® will allow physicians to focus on the management of the vital aspects of emergency patient management beyond anticoagulant reversal in dabigatran-treated patients.2 Praxbind® has the potential to remove a barrier to anticoagulant treatment, enabling eligible patients who require protection from clot-based strokes caused by AF to receive effective anticoagulation therapy. 

Find out more

For more information on the use of Praxbind®, including its safety, efficacy, dosing and administration, please visit our product website.

Reference

  1. Levine. MN. et al. Hemorrhagic complications of anticoagulant treatment. Chest. 2001;119(1,Suppl.):108S–21S.
  2. Pollack CV, et al. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost 2015;114:198–205.
  3. van Ryn J, et al. Dabigatran etexilate - a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010;103:1116–27.
  4. Boehringer Ingelheim Data on File.
  5. PRAXBIND® US Prescribing Information, 2015.
  6. Pollack C. V., et al. Idarucizumab for Dabigatran Reversal. NEJM. 2015;373:511-520.
  7. Glund S, et al. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial. Lancet. 2015;386:680–690.
  8. Aguilar. MI, Hart. R. Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks. Cochrane Database of Syst Rev. 2005;(3):CD001927.
  9. Marini. C. et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005;36:1115-9.
  10. Dobesh PP, Fanikos J. New Oral Anticoagulants for the Treatment of Venous Thromboembolism: Understanding Differences and Similarities. Drugs 2014;74:2015–32.
  11. Camm AJ., et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J. 2012;33(21):2719-47.
  12. Connolly. SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
  13. Connolly SJ. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
  14. Connolly SJ. et al. The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study. Circulation. 2013;128:237-43.
  15. Eriksson. BI. et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. Thromb Haemost. 2007;5:2178–85.
  16. Eriksson. BI. et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949–56.
  17. Eriksson. BI. et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, double blind, non-inferiority trial. Thromb Haemost. 2011;105:721-9.
  18. Schulman. S. et al. Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis. Circulation.2014;129:764-772.
  19. Schulman. S. et al. Extended use of dabigatran, warfarin or placebo in venous thromboembolism. N Engl J Med. 2013;368:709–18.
  20. European Medicines Agency Press Release - 25 May 2012: EMA/337406/2012. European Medicines Agency updates patient and prescriber information for Pradaxa. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/05/news_detail_001518.jsp&mid=WC0b01ac058004d5c1. Last accessed December 2015.
  21. FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin, 13 May 2014. Available at: http://www.fda.gov/drugs/drugsafety/ucm396470.htm. Last accessed: December 2015.
  22. Graham. DJ. et al. Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated With Dabigatran or Warfarin for Nonvalvular Atrial Fibrillation. Circulation. 2015;131:157-164.