In patients, the most frequently reported adverse reactions in ≥5% of patients treated with idarucizumab were hypokalemia, delirium, constipation, pyrexia, and pneumonia.In healthy volunteers, the most frequently reported adverse reactions in ≥5% of subjects treated with idarucizumab was headache.Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient: Patients with hereditary fructose intolerance may be at risk of adverse reactions.Hypersensitivity reactions: Discontinue administration and evaluate.Re-elevation of Coagulation Parameters: In patients with elevated coagulation parameters and reappearance of clinically relevant bleeding or requiring a second emergency surgery/urgent procedure, an additional 5 g dose of PRAXBIND may be considered.Resume anticoagulant therapy as soon as medically appropriate. Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.Limited evidence for redosing or dosing above 5g.Type: Humanized monoclonal antibody fragment, antidote/ anticoagulant reversal.

Idarucizumab fda approval