OVERVIEW:

Immediate and Complete Reversal*

The following is a brief overview about PRAXBIND, a specific reversal agent for Pradaxa® (dabigatran etexilate).

Indication

PRAXBIND is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with PRADAXA when reversal of the anticoagulant effects of dabigatran is needed:

  • For emergency surgery/urgent procedures
  • In life-threatening or uncontrolled bleeding

This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study.

There are serious risks and adverse reactions to consider when treating patients with PRAXBIND, including warnings and precautions for thromboembolic risk, re-elevation of coagulation parameters, hypersensitivity reactions and risks of serious adverse reactions in patients with hereditary fructose intolerance due to sorbitol excipient. Please see more complete details of these risks in the Important Safety Information below and the adverse reactions page.

Interim Analysis from RE-VERSE AD™

  • Reversal effects were evident immediately after administration
  • The median maximum reversal percentage in the first 4 hours was 100
  • 9 in 10 patients achieve complete reversal
  • In a limited number of patients, elevated coagulation parameters were observed between 12‑24 hours after administration

Immunogenicity

Low potential for immune reactions


  • 4% of volunteers showed low concentrations of treatment-emergent antibodies that may persist

Mechanism of Action

PRAXBIND specifically binds to dabigatran and its acylglucuronide metabolites and reverses their anticoagulant effect immediately after administration.

Recommended Dose

One recommended dose for all PRADAXA patients.

For intravenous use only. The recommended dose of PRAXBIND is 5 g, provided as two separate vials, each containing 2.5 g/50 mL of PRAXBIND. Two vials constitute one complete dose administered intravenously, as two consecutive infusions, or bolus injections by injecting both vials consecutively one after another via syringe.

Learn more about dosing and administration. View now >

Restarting Antithrombotic Therapy

Patients being treated with PRADAXA therapy have underlying disease states that predispose them to thromboembolic events. Reversing PRADAXA therapy exposes patients to the thrombotic risk of their underlying disease. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.

PRAXBIND is a specific reversal agent for PRADAXA, with no impact on the effect of other anticoagulant or antithrombotic therapies.

PRADAXA treatment can be re‑initiated 24 hours after administration of PRAXBIND.

RE-VERSE AD™= A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran.

*9 out of 10 patients achieve complete reversal.