Dabigatran - Dosing and Renal Function Effects

The presence of chronic kidney disease is an independent risk factor for increased bleeding events, including hemorrhagic stroke. Please carefully consider the risks and benefits of any oral anticoagulant prior to initiating therapy.

 

Stangier J et al. Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single-centre study.Clin Pharmacokinetics 2010; 49:259-68

CrCl FDA Recommended Dose  Treatment of DVT/PE

FDA Recommended Dose Stroke Prevention in AF

UW Medicine Restrictions AUC Cmax T 1/2
> 80 ml/min 150mg BID after 5-10 days of parenteral anticoagulant therapy 150 mg BID UWMedicine: RESTRICTED IF CrCl < 50 ml/min - - 14 hrs
50 – 80 ml/min 1.5 x increase 1.1 x increase 17 hrs
30 – 50 ml/min 3.2 x increase 1.7 x increase 19 hrs
<  30 ml/min Not recommended CrCl 15-30 ml/min: 75mg BID*
*based on computer modeling; not studied in patients

Consider alternative therapy

RESTRICTED

6.3 x increase 2.1 x increase 28 hrs
CrCl < 15 ml/min: not recommended

Consider alternative therapy

RESTRICTED

10-20 ml/min
on HD
Not recommended Not recommended

Consider alternative therapy

RESTRICTED

    34 hrs
(~65% removed by HD)