Idarucizumab (Praxbind)

Contents

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.

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

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

Prior to use, assess the 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.

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].

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 (Pradaxa) can be reinitiated 24 hours after administration of idarucizumab, as long as the bleeding has resolved and the patient is hemodynamically stable

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