Re-elevation of coagulation parameters: in a limited number of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant elevated coagulation parameters have occurred up to 24 hours after idarucizumab administration. Urinary protein testing: idarucizumab causes transient proteinuria as a physiological reaction to renal protein overflow. Hereditary fructose intolerance: the recommended dose of idarucizumab contains 4 g sorbitol as an excipient. Thromboembolic events: reversal of dabigatran exposes patients to the thrombotic risk of their underlying disease.

See the idarucizumab Product Information for complete information. 1Ī summary of idarucizumab precautions is provided below. When there are precautions, risk of idarucizumab use needs to be weighed against the potential benefit of emergency treatment.

There are no contraindications to idarucizumab use, although there are precautions. Other reversal agents are under development, but in contrast to idarucizumab, they are not yet approved for use and require further clinical evaluation. Normal haemostasis was reported in 93% of participants who underwent surgery or procedures. Median maximum reversal of dabigatran’s anticoagulant effects within 4 hours of idarucizumab administration was 100% (95% confidence interval 100% to 100%). More than 95% of the patients were receiving dabigatran for stroke prevention in the context of atrial fibrillation. In accordance with idarucizumab’s approved indication, enrolled participants were prescribed dabigatran, then presented with uncontrolled or life-threatening bleeding (group A, n = 301) or the need for urgent surgery or procedure (group B, n = 202).

The full cohort analysis of this study was published in August 2017. This medicine has been shown to rapidly and completely reverse the anticoagulant effects of dabigatran in the open-label, phase III RE‑VERSal Effects of idarucizumab on Active Dabigatran (RE‑VERSE AD) study. Clinical data to support the use of idarucizumab are still limited.

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