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
- see also http://www.reversalagent.com.au

it DOES NOT reverse other anticoagulant agents as it is specific for dabigatran!

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⁾

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

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

for patients who need to be re-started on dabigatran to prevent thromboembolic disease, it can be started 24hrs after the dose

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