Idarucizumab: Difference between revisions
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===Serious=== | ===Serious=== | ||
*Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate. | *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 | *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. | ||
or requiring a second emergency surgery/urgent procedure, an additional 5 g dose of PRAXBIND may be considered. | |||
*Hypersensitivity reactions: Discontinue administration and evaluate. | *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. | *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. | ||
Revision as of 12:58, 14 December 2015
Administration
- Type: Humanized monoclonal antibody fragment
- Dosage Forms: 2.5g/50ml vial
- Routes of Administration: IV
- Common Trade Names: PRAXBIND
Adult Dosing
- 5g (2 vials)
- Limited evidence for redosing or dosing above 5g
Pediatric Dosing
- No safety data available
Special Populations
- Pregnancy Rating: N
- Lactation risk: Not studied
Renal Dosing
- Adult: 5g
Hepatic Dosing
- Adult: Not studied
Contraindications
- None
Adverse Reactions
Serious
- 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.
Common
- 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
Pharmacology
- 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