Generic Name and Formulations:
Idarucizumab 2.5g/50mL; soln for IV infusion; preservative-free; contains sorbitol.
Boehringer Ingelheim Pharmaceuticals
Indications for PRAXBIND:
Reversal of the anticoagulant effects of dabigatran in emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding.
For IV use only. Administer 5g (2 vials) as 2 consecutive infusions or as bolus injection of both vials consecutively via syringe. Other additional dose: see Warnings/Precautions.
Thromboembolic risk; consider resuming anticoagulant therapy as soon as medically appropriate; can initiate dabigatran 24hrs after Praxbind administration. In patients having a reappearance of bleeding with elevated coagulation parameters or those requiring a second emergency surgery/urgent procedure and have elevated coagulation parameters, consider repeat administration of Praxbind 5g dose. Discontinue immediately if hypersensitivity reactions occur and treat appropriately. Hereditary fructose intolerance. Pregnancy. Nursing mothers.
Humanized monoclonal antibody fragment.
Headache, hypokalemia, delirium, constipation, pyrexia, pneumonia; hypersensitivity.
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