From the Guidelines
For patients with non-valvular atrial fibrillation and impaired renal function, the recommended dose of apixaban is 5 mg twice daily, but this should be reduced to 2.5 mg twice daily if the patient meets at least two of the following criteria: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL, as stated in the 2023 ACC/AHA/ACCP/HRS guideline for the diagnosis and management of atrial fibrillation 1. The dosing of apixaban in patients with non-valvular atrial fibrillation and impaired renal function is crucial to balance the risk of stroke and bleeding.
- The standard dose of apixaban is 5 mg twice daily, but dose adjustments are necessary in patients with impaired renal function to minimize the risk of bleeding.
- According to the 2023 ACC/AHA/ACCP/HRS guideline, the recommended dose of apixaban can be reduced to 2.5 mg twice daily in patients with certain characteristics, including age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL 1.
- The guideline also provides recommendations for apixaban dosing based on creatinine clearance, with a dose of 5 or 2.5 mg twice daily recommended for patients with creatinine clearance >15 mL/min, and a dose of 5 or 2.5 mg twice daily also recommended for patients with creatinine clearance <15 mL/min or on dialysis, although clinical data is limited in these populations 1.
- Regular monitoring of renal function is essential, especially in elderly patients or those with fluctuating renal function, to ensure that the dose of apixaban is appropriate and to minimize the risk of bleeding.
- Apixaban has a relatively lower renal clearance compared to other direct oral anticoagulants, making it a preferred option for patients with moderate renal impairment when anticoagulation is required for stroke prevention in atrial fibrillation, as demonstrated in the ARISTOTLE trial 1.
From the FDA Drug Label
The recommended dose of apixaban tablets for most patients is 5 mg taken orally twice daily. The recommended dose of apixaban tablets is 2.5 mg twice daily in patients with at least two of the following characteristics:
- age greater than or equal to 80 years
- body weight less than or equal to 60 kg
- serum creatinine greater than or equal to 1.5 mg/dL
Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation The recommended dose is 2.5 mg twice daily in patients with at least two of the following characteristics [see Dosage and Administration (2.1)]:
- age greater than or equal to 80 years
- body weight less than or equal to 60 kg
- serum creatinine greater than or equal to 1.5 mg/dL
The recommended use and dosing of Apixaban for patients with non-valvular atrial fibrillation and impaired renal function is:
- Dose: 2.5 mg twice daily in patients with at least two of the following characteristics:
- Age ≥ 80 years
- Body weight ≤ 60 kg
- Serum creatinine ≥ 1.5 mg/dL
- Renal Impairment: No dose adjustment is recommended for patients with renal impairment, including those with ESRD on dialysis 2.
- Key Considerations:
- Patients with end-stage renal disease on dialysis were not enrolled in clinical efficacy and safety studies with apixaban.
- Administration of apixaban at the usually recommended dose will result in concentrations of apixaban and pharmacodynamic activity similar to those observed in the ARISTOTLE study.
- It is not known whether these concentrations will lead to similar stroke reduction and bleeding risk in patients with ESRD on dialysis as was seen in ARISTOTLE 2.
From the Research
Recommended Use and Dosing of Apixaban
- Apixaban is recommended for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation 3, 4, 5, 6, 7.
- The normal dosage of apixaban is 5 mg orally twice daily 3, 7.
- However, the dosage may be reduced to 2.5 mg twice daily based on individual factors such as age, renal function, and body weight, as well as the concomitant use of potent dual inhibitors of cytochrome P450 3A4 and P-glycoprotein 3.
Considerations for Patients with Impaired Renal Function
- Apixaban has a safety profile and effectiveness in patients with renal impairment, with only 25% of the drug being eliminated through the kidneys 4.
- The use of apixaban is allowed by the Food and Drug Administration in patients with end-stage renal disease on hemodialysis 4.
- Patients with atrial fibrillation and impaired renal function have a higher risk of stroke or systemic embolism and major bleeding, but apixaban has been shown to be safe and efficacious in these patients 7.
- The 5 mg twice daily dose of apixaban is considered safe and appropriate for patients with only one dose-reduction criterion, including renal dysfunction 7.
Comparison to Warfarin
- Apixaban has been shown to be superior to warfarin in preventing stroke or systemic embolism, with less bleeding and lower mortality in patients with non-valvular atrial fibrillation 3, 4.
- Apixaban appears to be safer than warfarin in the presence of any degree of renal failure, with a lower risk of major bleeding 4.