When do we reduce the dose of Eliquis (apixaban) for atrial fibrillation (AFib)?

From the Guidelines

Eliquis (apixaban) dose should be reduced from the standard 5 mg twice daily to 2.5 mg twice daily for atrial fibrillation patients who meet at least two of the following criteria: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL.

Key Considerations for Dose Reduction

• The dose reduction is based on the patient's characteristics to minimize the risk of bleeding while maintaining the efficacy of the medication in preventing stroke and systemic embolism.
• Patients with severe renal impairment (creatinine clearance 15-29 mL/min) may also require dose reduction.
• The decision to reduce the dose should be made on a case-by-case basis, considering the individual patient's risk factors and medical history.

Rationale for Dose Adjustment

The recommendation for dose reduction is supported by the 2021 ACC expert consensus decision pathway for anticoagulant and antiplatelet therapy in patients with atrial fibrillation or venous thromboembolism undergoing percutaneous coronary intervention or with atherosclerotic cardiovascular disease 1.

Clinical Implications

• The medication should be taken consistently at the same times each day, with or without food.
• Patients should not stop taking Eliquis without consulting their healthcare provider due to increased stroke risk with discontinuation.
• Regular monitoring of renal function and bleeding risk is essential in patients taking Eliquis, especially in those with severe renal impairment or other risk factors for bleeding.

Evidence Base

The evidence for dose reduction in specific patient populations is based on studies such as the ARISTOTLE trial, which demonstrated the efficacy and safety of apixaban in patients with atrial fibrillation 1. However, the most recent and highest quality study, the 2021 ACC expert consensus decision pathway, provides the most up-to-date guidance on dose reduction for Eliquis in patients with atrial fibrillation 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

We reduce the dose of Eliquis (apixaban) for AFib 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. In these cases, the recommended dose is 2.5 mg twice daily 2.

From the Research

Dose Reduction of Eliquis (Apixaban) for Atrial Fibrillation

• The decision to reduce the dose of Eliquis (apixaban) for patients with atrial fibrillation is based on specific criteria, including age, weight, and renal function 3.
• Patients with at least two dose-reduction criteria, such as being 80 years or older, weighing 60 kg or less, and having a creatinine level of 1.5 mg/dL or higher, receive a reduced dose of apixaban of 2.5 mg twice daily 3.
• For patients with only one dose-reduction criterion, the 5 mg twice daily dose of apixaban is considered safe and efficacious 3.
• Renal impairment is a significant factor in determining the risk of stroke, bleeding, and death in patients with atrial fibrillation, and apixaban has been shown to be effective and safe in patients with normal, poor, and worsening renal function 4.
• In patients with severe renal dysfunction, apixaban may be a reasonable alternative to warfarin, with lower rates of bleeding and similar efficacy 5, 6.

Specific Criteria for Dose Reduction

• Age: 80 years or older 3
• Weight: 60 kg or less 3
• Renal function: creatinine level of 1.5 mg/dL or higher 3
• Creatinine clearance (CrCl): 25 to 30 mL/min 6

Studies Supporting Dose Reduction Criteria

• The ARISTOTLE trial demonstrated the efficacy and safety of apixaban in patients with atrial fibrillation, including those with renal impairment 4, 3, 6.
• A sub-analysis of the ARISTOTLE trial found that apixaban caused less bleeding than warfarin in patients with CrCl 25 to 30 mL/min 6.
• A study published in the Journal of Rural Medicine proposed a practical guide to choosing dabigatran or apixaban for patients with atrial fibrillation, recommending apixaban for most patients 7.