What is the recommended dosage and usage of Eliquis (apixaban) for patients with non-valvular atrial fibrillation and impaired renal function?

Dosage and Usage of Eliquis (Apixaban) for Patients with Non-valvular Atrial Fibrillation and Impaired Renal Function

For patients with non-valvular atrial fibrillation and impaired renal function, the standard dose of apixaban is 5 mg twice daily, with a reduced dose of 2.5 mg twice daily for patients meeting specific criteria related to age, weight, and renal function. 1

Standard Dosing Regimen

• The recommended dose of apixaban for most patients with non-valvular atrial fibrillation is 5 mg taken orally twice daily 1
• Apixaban has been shown to be more effective than warfarin in preventing stroke and systemic embolism with less risk of major bleeding events 2
• For patients with non-valvular atrial fibrillation with creatinine clearance >30 mL/min, no dose adjustment is needed 3

Dose Reduction Criteria

The dose should be reduced to 2.5 mg twice daily in patients with non-valvular atrial fibrillation who have at least two of the following characteristics:

• Age ≥80 years 1
• Body weight ≤60 kg 1
• Serum creatinine ≥1.5 mg/dL 1

This dose reduction is supported by clinical evidence from the ARISTOTLE trial, which showed that apixaban 2.5 mg twice daily was effective and safe in this population 2.

Renal Impairment Considerations

• For patients with end-stage renal disease (ESRD) on hemodialysis, the FDA-approved labeling recommends 5 mg twice daily, reduced to 2.5 mg twice daily if the patient is ≥80 years or weighs ≤60 kg 1
• Clinical efficacy and safety studies with apixaban did not enroll patients with ESRD on dialysis or patients with creatinine clearance <15 mL/min 1
• For patients with severe renal impairment (CrCl 15-29 mL/min) who do not meet other dose reduction criteria, the standard 5 mg twice daily dose can be used 3, 1

Clinical Evidence

• In the ARISTOTLE trial, apixaban 5 mg twice daily (with dose reduction to 2.5 mg twice daily in selected patients) was significantly better than warfarin with:

  • Fewer overall strokes (both ischemic and hemorrhagic) 2
  • Fewer systemic emboli 2
  • Less major bleeding 2
  • Lower mortality 2

• A retrospective cohort analysis showed no significant difference in major bleeding events between patients with preserved renal function and those with impaired renal function (CrCl <25 mL/min and/or SCr >2.5 mg/dL) receiving apixaban, regardless of dose 4

Important Considerations and Precautions

• Strict compliance with apixaban is critical as missing even one dose could result in a period without protection from thromboembolism 2
• Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with moderate or high risk of bleeding 1
• For procedures with low bleeding risk, discontinue apixaban at least 24 hours before the procedure 1
• There is no specific reversal agent widely available for apixaban in emergency situations, although andexanet alfa has been developed for this purpose 5
• Patients transitioning from warfarin to apixaban should start apixaban when INR is below 2.0 1

Common Pitfalls in Prescribing

• Underdosing is common, particularly in elderly patients (≥80 years) who meet only one dose reduction criterion 6
• Continuing home doses without reassessment of current criteria for dose adjustment 6
• Inappropriate dose reduction based on perceived bleeding risk rather than FDA-approved criteria 6
• Failure to adjust doses when patients develop renal impairment during treatment 6

By following these evidence-based dosing recommendations, clinicians can optimize stroke prevention while minimizing bleeding risk in patients with non-valvular atrial fibrillation and impaired renal function.