Recent studies indicate novel oral anticoagulants (NOACs) have favourable safety and efficacy compared with warfarin. NOACs are often patient-preferred due to their simpler dosing schedule, fewer interactions and no requirement for routine monitoring. However, unlike warfarin, a specific antidote has been unavailable to reverse their anticoagulant effect.
Idarucizumab (Praxbind®), a specific reversal agent for dabigatran, has recently received accelerated approval by the U.S. Food and Drug Administration and a positive recommendation from the European Medicines Agency. Phase III clinical trials assessing the safety and efficacy of idarucizumab are ongoing in Australia; the results of which will likely determine whether approval is granted by the Therapeutic Goods Administration (TGA).
Idarucizumab is a humanised monoclonal antibody fragment that binds with great affinity to dabigatran and its acyl glucuronide metabolites, resulting in rapid reversal of the anticoagulant effect of dabigatran. Idarucizumab is indicated for use in emergency surgery or life-threatening bleeding events occurring in patients treated with dabigatran. In 2014, 22 deaths associated with excessive bleeding were reported to the TGA in this patient group.
Use of idarucizumab will expose patients to the thromboembolic risks associated with their underlying condition. For this reason, resumption of anticoagulant therapy is recommended as soon as clinically appropriate. As with other biologicals, there is also a risk of immunogenicity.
- Praxbind® (idarucizumab) injection U.S. approved product information. Ridgefield: Boehringer Ingelheim Pharmaceuticals, Inc. Approved October 2015.
- Xiong Q, Lau Y, Senoo K, Hong K, Lip G. GW26-e2302 Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Patients with Atrial Fibrillation and Heart Failure: A Systemic Review and Meta-analysis of randomized trials. J Am Coll Cardiol. 2015; 66(16); C269–70.