We performed a retrospective health records review of all idarucizumab use, excluding use in those <18 years of age, between May 16, 2016, and August 1, 2019, at six Ontario tertiary care hospitals. Our objective was to assess the safety of idarucizumab among patients who received the drug within the first 3 years of its use in Canada. In this formulary review for a health system’s pharmacy and therapeutics committee, idarucizumab clinical trialsĪnd medication package insert were summarized and, after consulting with clinical experts from our institutions, practical recommendations for use were generated to ensure appropriate and safe use of this agent.Idarucizumab, a monoclonal antibody fragment that reverses the anticoagulant effect of dabigatran, was approved for use in Canada in 2016.

In the clinical trial described above, approximately 20% of patients required a second dose, which would further increase the cost of use. To treat 10 or 20 patients per year with a single 5 g dose is estimated to cost $34,825Īnd $69,650, respectively. The wholesale acquisition cost of two 2.5 g vials of idarucizumab is currently $3482.50.

This study is ongoing, but preliminary results showed reversalĮfficacy demonstrated a reasonable safety profile from the time of the infusion to 90 days after. Another randomized clinical trial assessed the safety and efficacy of idarucizumab in patients with either overt bleeding or undergoing emergency surgery where hemostasis was required. Results for the placebo group remained unchanged. In a randomized study with healthy volunteers, compared with placebo, idarucizumab reduced the clotting times for all tests assays (assessed pre-, end of-, and 24 hours after infusion), while the Requiring emergency surgery/urgent procedures or with life-threatening or uncontrolled bleeding.

The drug is indicated for dabigatran reversal in patients Idarucizumab (Praxbind), a humanized monoclonal antibody fragment was granted accelerated approval from the Food and Drug Administration in October 2015 as the first agent to reverse the effects of a novel oral anticoagulant.

Praxbind cost