Idarucizumab use for Reversal of the Anticoagulant Effects of Dabigatran

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Criteria for use

1. Indications:
   • Dabigatran-associated major or life-threatening uncontrolled bleeding restricted to neurosurgery, stroke team, emergency medicine, trauma, and hematology
   • Dabigatran reversal prior to emergent surgery or procedure that cannot be safely delayed
2. Exclusions:
   • Undetectable dabigatran anti-IIa activity level (< 0.04 mcg/mL)
   • Acute thrombosis or embolism
   • Last known dabigatran dose received > 48 hours prior
3. Caution:
   • Patients with hereditary fructose intolerance have increased risk for adverse effects (4 g of sorbitol contained per 5 g of idarucizumab)

Pharmacology

1. Idarucizumab is a monoclonal antibody that binds specifically to dabigatran to neutralize its anticoagulant effect. After binding the complex is eliminated from the system.
2. By the end of the infusion dabigatran free concentrations were undetectable and other surrogate markers of anticoagulant effect of dabigatran (ECT, dTT, aPTT, TT and ACT) were normalized.
3. These effects are sustained for 24 hours after administration.

Dosing

1. The recommended dose is 5 g given intravenously as a single dose (see administration below)
2. There are no data to support the use of an additional dose

Storage

1. Store in original package
2. Store in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF), do not freeze or shake
3. Unopened vials may be kept at room temperature 25 ºC (77 ºF) up to 48 hours (only 6 hours if exposed to light)

Administration

1. Product is supplied as 2 single-use glass vials of 2.5 g/50 mL of idarucizumab
2. Flush line with 0.9% NaCl prior to administration
3. Administer by intravenous rapid bolus
   • Hang vials and administer consecutively, for total dose of 5 g
   • Must use dedicated line (no compatibility data exist)
   • Must be used within 1 hour of spiking the vial

Monitoring

1. Baseline monitoring
   • Dabigatran anti-IIa assay for pre-operative indication
   • aPTT, platelet count, and hemoglobin/hematocrit

Use of idarucizumab with additional supportive therapies

1. Prothrombin complex concentrate (PCC)
   • Not routinely recommended as not known to provide any additional benefit
   • See PCC Guidelines for Use for additional information
2. Recombinant activated Factor VII (NovoSeven) (rfVIIa)
   • Not routinely recommended as not known to provide any additional benefit
   • See Factor VIIa Guidelines for Use for additional information
3. Refer to Emergent Reversal of Antithrombotic Agents for additional guidance

Drug Interactions

1. No compatibility studies have been performed; do not mix with other solvents or products