Idarucizumab (Praxbind)

A humanized monoclonal antibody fragment that binds dabigatran to neutralize its anticoagulant effects as measured by plasma-dilute thrombin time.   

Approved for reversal of the anticoagulant effect of dabigatran in the setting of:

  • life-threatening or uncontrolled bleeding
  • emergency surgery

Relevant Clinical Trials

Pollack CV, et al. Idarucizumab for dabigatran reversal. N Engl J Med. 2015; 373(6): 511-520. (RE-VERSE AD Trial)

 

Therapeutic Monitoring

  • prior to use, assess presence of dabigatran using elevated thrombin time as the marker for anticoagulant effect
  • monitor for signs/symptoms of clinically relevant bleeding and thromboembolic events.
  • idarucizumab will likely correct aPTT and plasma-dilute thrombin time, but the correlation of lab results with improved outcomes is not established.
  • plasma dabigatran concentrations can increase more than 12-24 hours after idarucizumab administration, likely due to re-distribution from the extravascular compartment. 
  • the safety and effectiveness of repeat treatment with idarucizumab have not been established.

Dosing and Administration

  • the recommended dose of idarucizumab (Praxibind) is 5 g intravenously, administered in two 2.5gm doses, no more than 15 minutes apart
  • infusion of each 2.5gm vial should take no longer than 5-10 minutes; the second vial must be administered within 15 minutes of the first vial.
  • idarucizumab must be administered within 1 hour after removal from the vials.
  • a pre-existing intravenous line may be used for administration of idarucizumab. The line must be flushed with sterile 0.9% Sodium Chloride Injection, USP solution prior to infusion.
  • no other infusion should be administered in parallel via the same intravenous access.

Drug Interactions

  • there are no known significant interactions.
  • In vitro data suggest that the inhibition of dabigatran by idarucizumab is not affected by coagulation factor concentrates [3- or 4-factor prothrombin complex concentrates (PCCs), activated PCC, or recombinant Factor VIIa]

Other Considerations

  • the safety and effectiveness of repeat treatment with idarucizumab have not been established.
  • renal impairment does not impact the reversal effect of idarucizumab. No dose adjustment is required in renally impaired patients.
  • dabigatran etexilate (Pradaxa) can be reinitiated 24 hours after administration of idarucizumab, as long as bleeding has resolved and patient is hemodynamically stable