What is the recommended dose of Eliquis (apixaban) in patients with End-Stage Renal Disease (ESRD)?

Recommended Dose of Eliquis (Apixaban) in End-Stage Renal Disease

In patients with End-Stage Renal Disease (ESRD) on dialysis, apixaban 5 mg twice daily is the recommended dose in the United States, although individualized decision-making should consider bleeding risk factors. 1

Dosing Recommendations Based on Guidelines

The dosing of apixaban in ESRD patients varies according to different guidelines:

1. US FDA-Approved Dosing (2025):

   • Apixaban 5 mg twice daily is approved for use in AF patients receiving hemodialysis 2
   • Dose reduction to 2.5 mg twice daily if patient has at least 2 of 3 criteria:
     • Age ≥80 years
     • Body weight ≤60 kg
     • Serum creatinine ≥1.5 mg/dL

2. CHEST Guidelines (2018):

   • In ESRD (CrCl <15 mL/min or dialysis-dependent), apixaban 5 mg twice daily is approved for use in AF patients receiving hemodialysis in the US only 1
   • For non-US patients, NOACs should generally not be used
   • Well-managed vitamin K antagonists (VKAs) with TTR >65-70% are suggested as an alternative

3. European Heart Rhythm Association (2018):

   • Routine use of NOACs including apixaban is not recommended in ESRD patients 1
   • Notes that apixaban 2.5 mg twice daily may provide plasma levels similar to those in patients with normal renal function

Evidence on Safety and Efficacy

Recent evidence suggests potential benefits of apixaban in ESRD patients:

• Meta-analysis data shows apixaban is associated with reduced risk of major bleeding compared to warfarin (pooled odds ratio 0.42; 95% CI, 0.28-0.61) in advanced CKD and ESRD patients 3

• In ESRD patients on dialysis specifically, the pooled odds ratio for major bleeding was 0.27 (95% CI, 0.07-0.95) favoring apixaban over warfarin 3

• A 2023 meta-analysis of ten studies including 6,693 ESRD patients on apixaban and 19,836 on warfarin found a risk ratio of 0.69 (0.57-0.84) for major bleeding favoring apixaban 4

• For VTE treatment in ESRD patients, apixaban was associated with lower risk of major bleeding (HR 0.81,95% CI: 0.70-0.94), intracranial bleeding (HR 0.69,95% CI 0.48-0.98), and gastrointestinal bleeding (HR 0.82,95% CI 0.69-0.96) compared to warfarin 5

Important Clinical Considerations

1. Renal Clearance: Apixaban has the lowest renal dependency for excretion (27%) among NOACs, making it potentially more suitable for ESRD patients 1

2. Monitoring:

   • Closely monitor renal function
   • Schedule frequent clinical follow-up
   • Reassess and address bleeding risk factors 1

3. Cautions:

   • Rare cases of extreme INR elevation have been reported with apixaban in ESRD patients 6
   • Concomitant antiplatelet therapy substantially elevates bleeding risk and should be used very judiciously 1

Conclusion

For ESRD patients requiring anticoagulation, apixaban 5 mg twice daily is FDA-approved in the US, with dose reduction to 2.5 mg twice daily if at least two high-risk criteria are present. Recent evidence suggests apixaban may have a more favorable bleeding profile compared to warfarin in this population, though continued monitoring for bleeding complications is essential.