Patients should resume their anticoagulant therapy as soon as medically appropriate. Reversing the effect of dabigatran exposes patients to the risk of blood clots and stroke from their underlying disease (such as atrial fibrillation). However, the safety and effectiveness of repeat treatment has not been established.

If reappearance of clinically relevant bleeding and elevated coagulation values are observed, administration of an additional 5 gram dose of Praxbind may be considered. In a limited number of patients, between 12 and 24 hours after Praxbind administration, elevated coagulation values were observed. The recommended dose of Praxbind is 5 grams, provided as two separate vials. 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. On October 16, the Food and Drug Administration (FDA) granted a special accelerated approval to Praxbind (idarucizumab).

Praxbind fda approval