Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors

American Journal of Hematology - Tập 87 Số S1 - 2012
Scott Kaatz1, Peter A. Kouides2, David García3, Alex C. Spyropolous4, Mark Crowther5, Jim Douketis5, Anthony Chan6, Andra H. James7, Stephan Moll8, Thomas L. Ortel9, Elizabeth M. Van Cott10, Jack Ansell11
1Department of Medicine, Henry Ford Hospital, Detroit, Michigan
2Department of Medicine, Mary M. Gooley Hemophilia Center, Rochester State, New York
3Department of Medicine, University of New Mexico, Albuquerque, New Mexico
4Division of Hematology/Oncology, University of Rochester Medical Center, Rochester, New York
5Department of Medicine, McMaster University, Hamilton, Ontario, Canada
6Division of Pediatric Hematology/Oncology, McMaster Children's Hospital, Hamilton, Ontario, Canada
7Department of Obstetrics and Gynecology and Medicine, Duke University, Durham, North Carolina
8Department of Medicine, University of North Carolina, School of Medicine, Chapel Hill, North Carolina
9Department of Medicine and Pathology, Duke University Medical Center, Durham, North Carolina
10Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts
11Department of Medicine, New York University School of Medicine, New York, New York

Tóm tắt

AbstractThe new oral anticoagulants dabigatran, rivaroxaban and apixaban have advantages over warfarin which include no need for laboratory monitoring, less drug–drug interactions and less food‐drug interactions. However, there is no established antidote for patients who are bleeding or require emergent surgery and there is a paucity of evidence to guide the clinical care during these situations. Members of thrombosis and anticoagulation groups participating in the Thrombosis and Hemostasis Summit of North America formulated expert opinion guidance for reversing the anticoagulant effect of the new oral anticoagulants and suggest: routine supportive care, activated charcoal if drug ingestion was within a couple of hours, and hemodialysis if feasible for dabigatran. Also, the pros and cons of the possible use of four factor prothrombin complex concentrate are discussed. Am. J. Hematol. 2012. © 2012 Wiley Periodicals, Inc.

Từ khóa


Tài liệu tham khảo

Boehringer Ingelheim Pharmaceuticals Inc. Pradaxa.2012. Available at:http://bidocs.boehringer‐ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt &folderPath=/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf.

Janssen Pharmaceuticals Inc. Xarelto.2011. Available at:http://www.xareltohcp.com/sites/default/files/pdf/xarelto_0.pdf#zoom=100.

HustenL. Apixaban gains priority FDA for stroke and VTE prevention in AF.2011. Available at:http://www.forbes.com/sites/larryhusten/2011/11/29/apixaban‐gains‐priority‐fda‐review‐for‐stroke‐and‐vte‐prevention‐in‐af/.

10.1056/NEJMoa1110899

Cohen A, 2011, Rivaroxaban compared with Enoxaparin for the prevention of venous thromboembolism in acutely ill medical patients ACC 11

10.1056/NEJMoa1105819

10.1056/NEJMoa1112277

10.1378/chest.11-2294

10.1378/chest.11-2295

10.1345/aph.1Q096

Baxter Healthcare Corp. Feiba: Prescribing information.2009. Available at:http://www.feiba.com/pdf/feiba‐500‐1000‐u‐pi‐0309.pdf.

10.1016/B978-141602401-9.10037-9

10.1160/TH11-05-0358

American Society of Hematology. 2011 Clinical practice guideline on the Evaluation and management of immune thrombocytopenia (ITP) 2011. Available at:http://www.hematology.org/Practice/Guidelines/2934.aspx.

Pharmaceutical Management Agency.2011. Guidelines for management of bleeding with dabigatran—For possible inclusion into local management protocols. New Zealand Government. Avilable at:http://pharmac.govt.nz/2011/06/13/Dabigatran%20bleeding%20management.pdf.

10.1016/j.thromres.2011.03.022

10.1111/j.1365-2125.2010.03753.x

10.2165/11318170-000000000-00000

Bristol‐Myers Squibb Pharmaceuticals. Data on file APIX 001 (Renal impairment).

10.1111/j.1538-7836.2009.03429.x

10.1056/NEJMoa1006221

10.1160/TH11-01-0052

van RynJ SiegerP Kink‐EibandM et al. Adsorption of Dabigatran etexilate in water or Dabigatran in pooled human plasma by activated charcoal in vitro 51st ASH Annual Meeting and Exposition. New Orleans LA;2009.

10.1161/STROKEAHA.111.624650

van RynJ RuehlD PriepkeH et al. reversibility of the anticoagulant effect of high doses of the direct thrombin inhibitor Dabigatran by recombinant factor VIIA or activated prothrombin complex concentrate. 13th Congress of the European Hematology Association. Copenhagen Denmark;2008. p148.

10.1111/j.1538-7836.2011.04498.x

van RynJ Kink‐EibandM ClemensA. The successful reversal of dabigatran‐induced bleeding by coagulation factor concentrates in a rat tail bleeding model do not correlate with ex vivo markers of anticogulation. 53rd ASH Annual Meeting and Exposition. San Diego CA;2011.

10.1161/CIRCULATIONAHA.111.029017

U.S. Food and Drug Administration. Xarelto: Highlights of prescribing information. 2011. Available at:http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s001lbl.pdf.

Tinel H, 2007, Recombinant factor VIIA partially reverses the anticoagulant effect of high‐dose rivaroxaban a novel, oral, direct factor XA inhibitor in rats, J Thromb Haemost, 5

GruberA MarzecUM HolcombJB. Potential of activated prothrombin complex concentrate and activated factor VII to reverse the Anticoagulant effects of rivaroxaban in primates. 50th ASH Annual Meeting and Exposition. San Francisco CA;2008.

10.1056/NEJMc1111095

10.1001/archinternmed.2011.314

Australian Government Therapeutic Goods Administration. Dabigatran (Pradaxa): Risk of bleeding relating to use.2011. Available at:http://www.tga.gov.au/safety/alerts‐medicine‐dabigatran‐111005.htm.

U.S. Food and Drug Administration. Pradaxa (dabigatran etexilate mesylate): Drug safety communication—Safety review of post‐market reports of serious bleeding events. 2011. Availble at:http://www.tga.gov.au/safety/alerts‐medicine‐dabigatran‐111005.htm.

European Medicines Agency. European medicines agency updates on safety of Pradaxa. 2011. Available at:http://www.ema.europa.eu/ema/index.jsp?curl= pages/news_and_events/news/2011/11/news_detail_001390.jsp∣=WC0b01ac05800 4d5c1&jsenabled=true.

Thông tin
Thông tin xuất bản

American Journal of Hematology

Tập 87 Số S1

Thông tin tác giả