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idarucizumab

idarucizumab (Praxbind)

introduction

  • idarucizumab is a humanised monoclonal antibody fragment (Fab) molecule derived from murine IgG1 isotype antibody molecule, marketed in Australia as Praxbind™ as a specific reversal agent for dabigatran
  • registered in Australia under TGA in 2016 and current cost in 2016 is around $AU3000 per dose
  • it DOES NOT reverse other anticoagulant agents as it is specific for dabigatran!

pharmacology

  • idarucizumab is a monoclonal antibody fragment
  • it binds dabigatran with an affinity that is 350 times as high as that observed with thrombin and thus binds free and thrombin-bound dabigatran and neutralizes its activity to produce an immediate and complete reversal of the anticoagulant effects of dabigatran without procoagulant effects in at least 90% of patients 1)

indications

  • patients taking dabigatran who need urgent reversal due to:
    • emergency surgical procedure, or,
    • life threatening, or uncontrolled bleeding

dose

  • available as 2.5 g/50 mL solution in a single-use vial
  • usual dose is 5g (ie. 2 vials) intravenous either as two consecutive infusions or two boluses
  • if using pre-existing line, ensure it is flushed with normal saline prior to administration
  • must be stored refrigerated
  • PPE must be worn when handling (gloves, mask, gown)
  • most hospitals require use to be approved by the hospital haematologist
  • SAS Product – need SAS form completed and forwarded to pharmacy

re-starting dabigatran

  • for patients who need to be re-started on dabigatran to prevent thromboembolic disease, it can be started 24hrs after the dose
idarucizumab.txt · Last modified: 2017/03/28 04:44 by 127.0.0.1

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