Idarucizumab is the first agent to be licensed to reverse the anticoagulant effect of a NOAC, and it is a specific reversal agent for dabigatran etexilate. Until recently, there were no specific antidotes for the NOACs unlike warfarin.

The most common adverse effect of anticoagulants is bleeding, ranging from mild events to serious and fatal haemorrhage. Licensed oral anticoagulants that are used in the UK include warfarin, and the non‑vitamin K antagonist oral anticoagulants (NOACs) apixaban, dabigatran etexilate, edoxaban and rivaroxaban. Development and investigations are underway for antidotes to reverse all available DOACs, yet thus far the US Food and Drug Administration (FDA) has approved only one agent that specifically reverses dabigatran etexilate mesylate, or Pradaxa (Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conn).Anticoagulant therapy is used for preventing and treating thromboembolism across various clinical indications. In the rare event of an extensive bleed, an effective antidote for the anticoagulant is desired. While the DOAC agents have demonstrated similar or a statistically reduced risk for major bleeding compared with warfarin in clinical trials for treatment of nonvalvular atrial fibrillation and venous thromboembolism, bleeding remains a concern with all anticoagulants. The approval of the first reversal agent in the US for a direct oral anticoagulant (DOAC) propels the evolution of patient care for those who require anticoagulation. The use of anticoagulants that directly affect thrombin, or the clotting factor Xa, has become mainstream practice over the past few years, often replacing warfarin as first-line therapy.

Cost of idarucizumab