Idarucizumab is a humanised monoclonal antibody fragment that binds to dabigatran with a high affinity and neutralises its anticoagulant effect. Idarucizumab does not reverse the effects of other anticoagulants.
Rapid effect after intravenous administration
Idarucizumab should be given at a dose of 5g. It is administered as two consecutive 2.5g intravenous infusions over 5 to 10 minutes each or as a bolus injection.
A second dose can be considered in the following situations:
- recurrence of clinically relevant bleeding together with prolonged clotting times
- if potential re-bleeding would be life-threatening and prolonged clotting times are observed
- patients require a second urgent procedure and have prolonged clotting times.
Interim analysis of the prospective open-label RE-VERSE AD study showed that the reversal effects of idarucizumab were evident within minutes of administration. Reversal was complete and sustained for at least 24 hours in most patients.
Resumption of anticoagulant therapy
Neutralisation of the anticoagulant effect of dabigatran exposes patients to the thrombotic risk of their condition, and resumption of anticoagulant therapy should be considered as soon as appropriate.
Dabigatran can be restarted 24 hours after administration of idarucizumab. Other antithrombotic therapy can be restarted at any time. Re-initiation of antithrombotic therapy of any kind should only occur if the patient is stable with adequate haemostasis.