Dabigatran (Pradaxa)Published on Anticoagulation Services(https://depts.washington.edu/anticoag/home)

Dabigatran (Pradaxa) Tags: dabigatrandirect thrombin inhibitoralternative anticoagulants

An oral direct thrombin inhibitor approved for :

1) Stroke prevention in atrial fibrillation (150 mg twice daily)

2) Treatment of DVT/PE in patients who have been treated with a parenteral anticoagulantfor 5-10 days (150 mg twice daily)

3) Long term prevention of recurrent DVT/PE in patients who have been previously treatedfor DVT/PE (150 mg twice daily)

4) Prevention of DVT/PE following hip replacement (110 mg after surgery and hemostasis, then 220mg daily)

Relevant Clinical Trials

Stroke Prevention in Atial Fibrillation

Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med2009; 361(12)1139-1151. (RE-LY)

Treatment of DVT/PE

Schulman S, et al. Dabigatran versus warfarin in the treatment of acute venousthromboembolism. N Engl J Med 2009; 361(24):2342-2352. (RE-COVER)

Extended Treatment of DVT/PE

Schulman S, et al. Extended use of dabigatran, warfarin, or placebo in venousthromboembolism. N Engl J Med 2013; 368(8):709-718. (RE-MEDY, RE-SONATE)

Hip Replacement

Eriksson BI, et al. Dabigatran etexilate versus enoxaparin for prevention of venousthromboembolism after total hip replacement: a randomised, double-blind, non-inferioritytrial. Lancet 2007; 370(9591):949-956. (RE-NOVATE)Eriksson BI, et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primarytotal hip arthroplasty (RE-NOVATE II). A randomised, double-blind, non-inferiority trial.Thromb Haemost 2011; 105(4):721-729. (RE-NOVATE II)

Therapeutic Monitoring

Dabigatran is not intended to be monitored using routine coagulation testing. Its fixed dosing is not

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Dabigatran (Pradaxa)Published on Anticoagulation Services(https://depts.washington.edu/anticoag/home)

intended to be adjusted on the basis of any coagulation laboratory parameter. In certain clinicalsituations in which the presence or absence of anticoagulant effect induced by dabigatran needs tobe measured, the UW Medicine Dabigatran Assay can be used.

Administration Considerations

Do not break, chew or crush capsulesKeep capsules in original container – do not store or place in other containersAfter opening original container, capsules expire in 120 days

Suggestions for Reversal and Management of Bleeding

Mild Bleeding

Delay next dose or discontinue therapy

Moderate to Severe Bleeding

Symptomatic treatmentMechanical compressionSurgical interventionFluid replacement and hemodynamic supportBlood product transfusionOral charcoal (if dabigatran administered < 2 hrs prior)Hemodialysis (60% removal)

Life Threatening Bleeding

Measures aboveCharcoal filtrationIdarucizumab (Praxbind)

Source URL (modified on 04/23/2020 - 10:11):https://depts.washington.edu/anticoag/home/content/dabigatran-pradaxa-0

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