Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
The recommended dose of Idarucizumab is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab (see Figure 1).Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study. This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. In life-threatening or uncontrolled bleeding.For emergency surgery/urgent procedures.Idarucizumab is indicated in patients treated with dabigatran when reversal of the anticoagulant effects of this drug is needed: Common adverse reactions include headache (5%) in healthy volunteers and hypokalemia, delirium, constipation, pyrexia, and pneumonia (5%) in patients.Īdult Indications and Dosage FDA-Labeled Indications and Dosage (Adult) Indications Idarucizumab is a humanized monoclonal antibody fragment (Fab) that is FDA approved for the treatment of patients treated with dabigatran when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
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