In this episode I will:
1. Review an article about idarucizumab for dabigatran reversal
2. Answer a drug information question: "Can I use rivaroxaban to treat a pulmonary embolism (PE) in a patient with active cancer?"
3. Share a resource I use that is a collection of evidence based critical care guidelines
Article
Idarucizumab for Dabigatran Reversal
Lead author: Charles V. Pollack
Published in New England Journal of Medicine (NEJM) August 6, 2015
Background
Idarucizumab for dabigatran reversal is in the news again since the FDA approved the drug on October 16, 2015. This article is interim analysis of an ongoing study of idarucizumab (RE-VERSE AD). It was this study that the FDA based its approval of idarucizumab for dabigatran reversal.
Purpose
To determine the effects of idarucizumab, an antibody fragment, that was developed to reverse the anticoagulant effects of dabigatran.
Methods
The study is a prospective cohort study using 5 g of intravenous idarucizumab to reverse the anticoagulant effects of dabigatran in patients who had serious bleeding (group A) or required an urgent procedure (group B). The primary end point is the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab. A secondary end point is the restoration of hemostasis.
Results
This interim analysis included 90 patients who received idarucizumab (51 patients in group A and 39 in group B). Among 68 patients with an elevated dilute thrombin time and 81 with an elevated ecarin clotting time at baseline, the median maximum percentage reversal was 100%. Idarucizumab normalized the test results in 88 to 98% of the patients, an effect that was evident within minutes. Among 35 patients in group A who could be assessed, hemostasis, as determined by local investigators, was restored at a median of 11.4 hours. Among 36 patients in group B who underwent a procedure, normal intraoperative hemostasis was reported in 33, and mildly or moderately abnormal hemostasis was reported in 2 patients and 1 patient, respectively. One thrombotic event occurred within 72 hours after idarucizumab administration in a patient in whom anticoagulants had not been reinitiated.
Conclusion
The authors concluded that idarucizumab completely reversed the anticoagulant effect of dabigatran within minutes.
I checked with my purchasing pharmacist (thanks Mark!) - idarucizumab is now available via drop ship at a cost of $3500.