Idarucizumab

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

See Also

• Dabigatran (Pradaxa) reversal