From the FDA Drug Label
In ARISTOTLE, patients were randomized to apixaban 5 mg orally twice daily (or 2. 5 mg twice daily in subjects with at least 2 of the following characteristics: age greater than or equal to 80 years, body weight less than or equal to 60 kg, or serum creatinine greater than or equal to 1.5 mg/dL) or to warfarin (targeted to an INR range of 2.0 to 3. 0)
The International Normalized Ratio (INR) range for patients with atrial fibrillation on warfarin in the ARISTOTLE study was 2.0 to 3.0 1.
- The INR range is specified for warfarin, not apixaban, as apixaban does not require INR monitoring.
- The study aimed to compare the efficacy and safety of apixaban with warfarin in patients with nonvalvular atrial fibrillation.
- Patients treated with warfarin had a mean percentage of time in therapeutic range (INR 2.0 to 3.0) of 62% 1.
From the Research
Eliquis (apixaban) does not require INR monitoring for patients with atrial fibrillation, as it is a direct oral anticoagulant (DOAC) that works by directly inhibiting factor Xa in the coagulation cascade, having a predictable anticoagulant effect at fixed doses, eliminating the need for routine blood monitoring 2.
Key Points
- The standard dosing for atrial fibrillation is typically 5 mg twice daily, though a reduced dose of 2.5 mg twice daily is recommended for patients meeting at least two of these criteria: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL 3.
- Patients should take Eliquis consistently at approximately 12-hour intervals with or without food and should not stop taking it without consulting their healthcare provider, as this could increase stroke risk.
- If transitioning from warfarin to Eliquis, warfarin should be discontinued and Eliquis started when the INR is below 2.0.
- A study published in 2020 found that apixaban caused less major bleeding and major or clinically relevant nonmajor bleeding compared to warfarin in patients with atrial fibrillation and advanced chronic kidney disease, supporting the use of apixaban in this population 4.
Considerations
- The pharmacokinetic profile of apixaban is characterized by a median daily steady-state area under the curve of 5512 ng/(mL·h) for patients with CrCl 25 to 30 mL/min, which is within the range demonstrated for patients with CrCl >30 mL/min 4.
- Randomized, controlled studies evaluating the safety and efficacy of apixaban are urgently needed in patients with advanced chronic kidney disease, including those receiving dialysis 4.