Is Eliquis (apixaban) safe for patients with stage 5 renal failure and severely impaired renal function (GFR of 15)?

Safety of Eliquis (Apixaban) in Stage 5 Renal Failure with GFR 15

Eliquis (apixaban) can be used with caution in patients with stage 5 renal failure with a GFR of 15 mL/min, but dose adjustment to 2.5 mg twice daily is recommended to reduce bleeding risk.

Understanding Stage 5 Chronic Kidney Disease

Stage 5 chronic kidney disease (CKD) is defined as:

• GFR <15 mL/min/1.73 m² (kidney failure) 1
• Considered end-stage renal disease (ESRD)
• Associated with increased morbidity and mortality, particularly from cardiovascular disease 1

Apixaban Dosing in Severe Renal Impairment

FDA-Approved Dosing

The FDA label for apixaban recommends:

• Dose reduction to 2.5 mg twice daily in patients with at least two of the following characteristics 2:
  • Age ≥80 years
  • Body weight ≤60 kg
  • Serum creatinine ≥1.5 mg/dL

For Patients with GFR 15 mL/min

• For patients with severe renal impairment (GFR 15-29 mL/min):
  • For stroke prevention in atrial fibrillation: 2.5 mg twice daily is recommended 1
  • For VTE treatment: Standard dosing may be considered with careful monitoring 2

Safety Profile in Severe Renal Impairment

Recent evidence suggests that apixaban may have a favorable safety profile compared to warfarin in patients with severe renal impairment:

• A 2022 systematic review found that apixaban showed an equivalent and sometimes better safety profile than warfarin regarding bleeding events in patients with Stage 4 and 5 CKD 3

• A 2023 meta-analysis demonstrated significantly lower rates of major bleeding (RR 0.72; 95% CI 0.62-0.84) and minor bleeding events (RR 0.42; 95% CI 0.21-0.86) with apixaban compared to warfarin in patients with severe renal failure 4

• A 2021 study comparing apixaban 5 mg twice daily versus 2.5 mg twice daily in patients with CKD stage 4 and 5 found no significant difference in major bleeding events (9.1% vs 12.3%, P=1.00) 5

Clinical Considerations and Monitoring

When using apixaban in patients with GFR of 15 mL/min:

1. Dose adjustment: Use 2.5 mg twice daily if the patient has at least two risk factors (age ≥80, weight ≤60 kg, or serum creatinine ≥1.5 mg/dL)

2. Regular monitoring:

   • Renal function should be evaluated before initiation and at least annually 1
   • More frequent monitoring (every 3 months) is recommended for patients with eGFR <30 mL/min/1.73 m² 6

3. Bleeding risk assessment:

   • Monitor for signs of bleeding
   • Consider concomitant medications that may increase bleeding risk

Common Pitfalls to Avoid

1. Failure to adjust medication doses based on current renal function can lead to adverse effects

2. Inadequate monitoring of renal function and potential drug interactions

3. Not considering drug interactions with P-glycoprotein inducers or inhibitors, which may affect apixaban levels 1

4. Delayed nephrology referral - patients with GFR <30 mL/min should be referred to nephrology 6

In conclusion, while apixaban can be used in patients with stage 5 renal failure with GFR 15 mL/min, careful dose adjustment, monitoring, and consideration of individual bleeding risk are essential to maximize safety and efficacy.