Drug reference

Idarucizumab

Monoclonal Antibody · Anticoagulant Reversal Agent

Also known as Praxbind

Monoclonal AntibodyAnticoagulant Reversal Agent

CDSCO approvedSchedule H

EXCRETION

—

not curated

INTERACTIONS

—

none in our sources

PREGNANCY

Manufacturer advises use only if potential benefit outweighs risk—no information available.

FDA category + note

Mechanism

Idarucizumab is a humanized monoclonal antibody Fab fragment that specifically binds to dabigatran and its metabolites. This binding neutralizes the anticoagulant effect of dabigatran, thereby rapidly reversing its action.

Indications

Rapid reversal of dabigatran for emergency proceduresRapid reversal of dabigatran in life-threatening or uncontrolled bleeding (specialist supervision in hospital)reversal of dabigatran in patients with serious bleeding (such as intracranial bleeding)reversal of dabigatran in patients requiring urgent surgery or interventionreversal of dabigatran in cases of major bleeding

Dosing

Adult: 5 g administered intravenously as two consecutive infusions, each over 5–10 minutes, or as a bolus injection. An additional 5 g may be given if required.
Pediatric: Pediatric use has not been established.
Max dose: 10 g total (initial 5g, plus an additional 5g if required)

Pharmacokinetics

Onset

Rapid

Half-life

Approximately 1 hour (in patients with normal renal function)

Excretion

Primarily excreted by the kidneys

Side effects

Common

Back painCerebrovascular insufficiencyChest discomfortCoughPostural dizzinessDry mouthDyspnoeaFeeling hotFeverFlushingGastrointestinal discomfortHeadacheHyperhidrosisMuscle spasmsNauseaPalpitationsPeripheral coldnessSkin reactionsAltered taste

Serious