idarucizumab (Praxbind)

see also:

• product information sheet (pdf)

• 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

• 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