If coagulation parameters (eg, aPTT) re-elevate and clinically relevant bleeding occurs or if a second emergency surgery/urgent procedure is required and patient has elevated coagulation parameters, consider administration of an additional 5 g (limited data to support) in patients with dabigatran-associated intracranial hemorrhage, if refractory bleeding occurs after initial idarucizumab dose, consider re-dosing and/or hemodialysis (NCS/SCCM ). Reversal of dabigatran: IV: 5 g (administered as 2 separate 2.5 g doses no more than 15 minutes apart) (Pollack 2017).
There are no contraindications listed in the manufacturer's labeling.Ĭanadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to idarucizumab or any component of the formulation. Reversal of dabigatran: Reversal of the anticoagulant effects of dabigatran for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. However, renal impairment did not impact the reversal effect of idarucizumab. Total clearance was reduced and mean exposure (AUC) was increased in varying degrees of renal impairment. Usually at least 24 hours Half-Life EliminationĤ7 minutes (initial) 10.3 hours (terminal) Use in Specific Populations Special Populations: Renal Function Impairment Uncontrolled bleeding: Effects observed within minutes and hemostasis is restored at a median of 11.4 hours (Pollack 2015) Duration of Action Urine (~32% within the first 6 hours and <1% in the following 18 hours) Onset of Action Pharmacokinetics/Pharmacodynamics Distributionīiodegradation of small peptides and amino acids Excretion
Idarucizumab, a specific reversal agent for dabigatran, is a humanized monoclonal antibody fragment (Fab) that binds specifically to dabigatran and its acylglucuronide metabolites with an affinity for dabigatran that is ~350 times greater than that of thrombin, and neutralizes the anticoagulant effect within minutes (Das 2015 Schiele 2013).
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