FDA Approves Dabigatran Reversal Agent Idarucizumab
The FDA has granted accelerated approval to idarucizumab (Praxbind) for the treatment of patients treated with dabigatran (Pradaxa).
The US Food and Drug Administration (FDA) has granted accelerated approval to idarucizumab (Praxbind) for the treatment of patients treated with dabigatran (Pradaxa) when reversal of the anticoagulant effects of dabigatran is required for emergency surgery or urgent procedures, or in instances of life-threatening or uncontrolled bleeding.
Dabigatran is an oral direct thrombin inhibitor used as an alternative to warfarin often because it does not require blood monitoring for INR; however, the lack of reversal agent has led many clinicians to opt for prescribing warfarin.
Approval of idarucizumab was based on findings from three placebo-controlled trials that included a total of 283 patients who were randomly assigned to receive dabigatran and idarucizumab or dabigatran and placebo.
An ongoing open-label trial is evaluating idarucizumab in 123 patients treated with dabigatran who had life-threatening or uncontrolled bleeding, or who required emergency procedures.
Preliminary results have shown complete reversal of the anticoagulant effect of dabigatran within the first 4 hours after administration of 5 g idarucizumab in 89% of patients.
In regard to safety, the most common adverse events related to idarucizumab were headache, hypokalemia, delirium, constipation, pyrexia, and pneumonia.
Administration of idarucizumab is recommended at a dose of 5 g intravenously as two consecutive 2.5-g infusions or bolus injection by injecting the contents of both 2.5 g vials consecutively via syringe.
1. Idarucizumab. U.S. Food and Drug Administration Approved Drugs website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDAppr/ucm467396.htm. October 16, 2015. Accessed October 21, 2015.