- Type: Humanized monoclonal antibody fragment, antidote/anticoagulant reversal
- Dosage Forms: 2.5g/50ml vial
- Routes of Administration: IV
- Common Trade Names: PRAXBIND
- 5g (2 vials)
- Limited evidence for redosing or dosing above 5g
- No safety data available
- Adult: 5g
- Adult: Not studied
- Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate.
- 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.
- Hypersensitivity reactions: Discontinue administration and evaluate.
- 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.
- In healthy volunteers, the most frequently reported adverse reactions in ≥5% of subjects treated with idarucizumab was headache
- In patients, the most frequently reported adverse reactions in ≥5% of patients treated with idarucizumab were hypokalemia, delirium, constipation, pyrexia, and pneumonia
- Half-life: 10.3h
- Metabolism: Protein catabolism
- Excretion: Renal
Mechanism of Action
- Fab that binds to dabigatran and its acylglucuronide metabolites with higher affinity than the binding affinity of dabigatran to thrombin, neutralizing their anticoagulant effects
FDA approved idarucizumab after preliminary results of the Reversal Effects of Idarucizumab on Active Dabigatran (RE-VERSE AD) study.
- FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm.