Idarucizumab is a monoclonal antibody fragment specifically targeted to 
dabigatran. It has demonstrated prompt and durable reversal of the anticoagulant 
effects of dabigatran in animal studies and phase 1 studies of young, elderly, 
and renally impaired volunteers. Although elective invasive procedures and most 
bleeding complications in dabigatran-treated patients can be managed by 
temporarily stopping dabigatran therapy and using supportive measures, there are 
rare clinical situations that require urgent reversal of the anticoagulant 
effect of dabigatran. The effectiveness and safety of 5 g of intravenous 
idarucizumab is being investigated in a prospective, open-label, single-cohort 
study in patients with serious bleeding or in those requiring an urgent 
procedure. In an interim analysis of the first 90 participants, idarucizumab 
rapidly and completely reversed the anticoagulant activity of dabigatran in 
88%-98% of participants, and there were no safety concerns, with no deaths or 
serious adverse events being attributable to idarucizumab. Supported by these 
interim results, idarucizumab has been approved in the United States and the 
European Union for use when reversal of the anticoagulant effects of dabigatran 
is needed for emergency surgery/urgent procedures or in patients with 
life-threatening or uncontrolled bleeding. Clinical use of idarucizumab should 
follow the same processes as patient enrollment in this study, which is 
projected to be completed in 2016. The outcomes achieved with this specific 
reversal agent are likely to be of continued interest to treating physicians.