Idarucizumab: Difference between revisions
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==Administration== | ==Administration== | ||
*Type: Humanized monoclonal antibody fragment | *Type: Humanized monoclonal antibody fragment, [[antidote]]/[[anticoagulant reversal]] | ||
*Dosage Forms: 2.5g/50ml vial | *Dosage Forms: 2.5g/50ml vial | ||
*Routes of Administration: IV | *Routes of Administration: IV | ||
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==Special Populations== | ==Special Populations== | ||
*[[Drug Ratings in Pregnancy|Pregnancy Rating]]: | *[[Drug Ratings in Pregnancy|Pregnancy Rating]]: B, no studies exist | ||
*[[Lactation risk categories|Lactation risk]]: Not studied | *[[Lactation risk categories|Lactation risk]]: Not studied | ||
===Renal Dosing=== | ===Renal Dosing=== | ||
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[[Category:Pharmacology]] | [[Category:Pharmacology]] | ||
[[Category:Heme/Onc]] | |||
Latest revision as of 20:33, 22 September 2019
Administration
- Type: Humanized monoclonal antibody fragment, antidote/anticoagulant reversal
- 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: B, no studies exist
- 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
Comments
FDA approved idarucizumab after preliminary results of the Reversal Effects of Idarucizumab on Active Dabigatran (RE-VERSE AD) study.[1]
See Also
References
- ↑ FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm.