The most common side effects reported were headache, hypokalemia, confusion, constipation, fever, and pneumonia. This effect lasted for at least 24 hours in the majority of patients. Administration of Praxbind results in an almost immediate reversal of dabigatran activity that was fully apparent in 89% of patients within four hours. Praxbind works by binding to both free and thrombin-bound dabigatran to completely neutralize its anticoagulant activity without procoagulant effects. Praxbind is a humanized monoclonal antibody fragment (Fab) designed as a reversal agent specifically for dabigatran. The primary advantage of dabigatran is that it has a pharmacokinetic profile that produces predictable anticoagulation responses and does not require frequent laboratory monitoring. Dabigatran is the first in a new class of oral anticoagulants that act by directly blocking the activity of thrombin (factor IIa), the central enzyme in the coagulation cascade responsible for clot (thrombus) formation. The FDA approved dabigatran in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE). Praxbind is indicated for patients treated with Pradaxa (dabigatran etexilate) when reversal of the anticoagulant effects are needed for life-threatening or uncontrolled bleeding. National Library of Medicine.On October 16, the Food and Drug Administration (FDA) granted a special accelerated approval to Praxbind (idarucizumab).
^ Pollack CV, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, et al.^ a b c "Praxbind- idarucizumab injection".
^ "Praxbind 2.5 g/50 mL solution for injection/infusion - Summary of Product Characteristics (SmPC)".
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