Idarucizumab

Revision as of 15:54, 22 March 2016 by Ostermayer (talk | contribs) (Text replacement - "Category:Drugs" to "Category:Pharmacology")

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

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

  1. FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm.