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 Apixaban (Eliquis) for Non-valvular Atrial Fibrillation with Impaired Renal Function

For patients with non-valvular atrial fibrillation and impaired renal function, apixaban (Eliquis) should be dosed at 5 mg twice daily for most patients, with a reduced dose of 2.5 mg twice daily for patients who meet specific criteria related to age, weight, and renal function. 1

Standard Dosing Recommendations

• The standard recommended dose of apixaban for patients with non-valvular atrial fibrillation is 5 mg taken orally twice daily 1
• Apixaban has been shown to be a relatively safe and efficacious alternative to warfarin in patients with non-valvular AF who have at least one additional risk factor for stroke 2
• In the ARISTOTLE trial, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with AF 2, 3

Dose Reduction Criteria

The dose should be reduced to 2.5 mg twice daily in patients who have at least two of the following characteristics:

• Age greater than or equal to 80 years 1
• Body weight less than or equal to 60 kg 1
• Serum creatinine greater than or equal to 1.5 mg/dL 1

Specific Renal Impairment Considerations

• For patients with end-stage renal disease (ESRD) on dialysis, apixaban can be administered at the usually recommended dose (either 5 mg twice daily or 2.5 mg twice daily based on the criteria above) 1
• Clinical efficacy and safety studies with apixaban did not enroll patients with ESRD on dialysis or patients with creatinine clearance (CrCl) <15 mL/min; therefore, dosing recommendations are based on pharmacokinetic and pharmacodynamic data 1
• In patients with severe renal impairment, apixaban has shown similar safety outcomes compared to patients with preserved renal function, regardless of dose 4

Clinical Evidence Supporting Use in Renal Impairment

• In the ARISTOTLE trial, apixaban showed consistent efficacy in subjects with impaired renal function (estimated glomerular filtration rate <80 mL/min) 2
• Significantly greater reduction in major bleeding was observed among those with more advanced renal dysfunction (estimated glomerular filtration rate ≤50 mL/min) compared to warfarin 2
• A retrospective cohort analysis found no difference in major bleeding events between patients with preserved renal function versus impaired renal function (CrCl <25 mL/min and/or serum creatinine >2.5 mg/dL) taking apixaban 5 mg or 2.5 mg twice daily 4

Monitoring Recommendations

• Baseline assessment of renal function is essential before initiating apixaban therapy 2
• Regular monitoring of renal function is recommended during treatment, especially in elderly patients or those with known renal impairment 5
• If a patient's renal function deteriorates to meet the dose reduction criteria, the dose should be adjusted accordingly 1

Important Considerations and Precautions

• Unlike some other direct oral anticoagulants, apixaban dose adjustments are based on multiple criteria (age, weight, and renal function), which can lead to prescribing errors if not carefully evaluated 6
• There is no specific reversal agent widely available for apixaban, although activated charcoal may be useful if administered within 6 hours of ingestion 1, 3
• Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of bleeding 1
• The safety and efficacy of combining apixaban with an antiplatelet agent have not been established 2

By following these dosing recommendations based on patient-specific factors, apixaban can be safely and effectively used for stroke prevention in patients with non-valvular atrial fibrillation and impaired renal function.