From the Guidelines
Apixaban dose should be reduced to 2.5 mg twice daily if a patient meets at least two of the following three criteria: age 80 years or older, body weight 60 kg or less, or serum creatinine 133 μmol/L or greater. These criteria are based on the most recent guidelines for the management of atrial fibrillation, as outlined in the 2024 ESC guidelines 1. The dose reduction is necessary to minimize the risk of bleeding while maintaining effective anticoagulation.
Key factors to consider when reducing the apixaban dose include:
- Age: 80 years or older
- Body weight: 60 kg or less
- Serum creatinine: 133 μmol/L or greater These factors can increase the risk of bleeding and require a dose adjustment to ensure safe and effective treatment.
It is essential to monitor patients closely for both thrombotic and bleeding events when prescribing the reduced dose, as underdosing may lead to inadequate anticoagulation while overdosing increases bleeding risk. The 2024 ESC guidelines provide the most up-to-date recommendations for apixaban dosing, and clinicians should refer to these guidelines when making treatment decisions 1.
From the FDA Drug Label
The recommended dose of apixaban tablets is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE For patients receiving apixaban tablets doses of 5 mg or 10 mg twice daily, reduce the dose by 50% when apixaban tablet is coadministered with drugs that are combined P-glycoprotein (P-gp) and strong cytochrome P450 3A4 (CYP3A4) inhibitors
The parameters for reducing apixaban dose to 2.5 mg twice daily are:
- After at least 6 months of treatment for DVT or PE
- When coadministered with combined P-gp and strong CYP3A4 inhibitors, for patients receiving apixaban tablets doses of 5 mg or 10 mg twice daily, the dose should be reduced by 50% 2
From the Research
Parameters for Reducing Apixaban Dose
The parameters for reducing apixaban dose to 2.5 mg twice daily (bd) are based on specific criteria, including:
- Age ≥80 years
- Body weight ≤60 kg
- Serum creatinine ≥1.5 mg/dL
Patients who fulfill at least 2 of these 3 criteria are recommended to receive a reduced dose of apixaban, 2.5 mg twice daily 3.
Clinical Outcomes and Dose Reduction Criteria
Studies have examined the validity of alternative definitions based on age and renal function alone for dose reduction criteria. The results suggest that the types or combinations of the three apixaban dose reduction criteria do not have a significant impact on effectiveness and safety in elderly patients with atrial fibrillation receiving on-label dose of apixaban 4.
Off-Label Reduced Dose Apixaban
Off-label reduced dosing of apixaban is common in older adults with nonvalvular atrial fibrillation. However, no significant association was found between empiric off-label reduced dosing and stroke or bleeding outcomes 5.
Evaluation of Dose-Reduced Direct Oral Anticoagulant Therapy
Dose adjustments for apixaban are recommended for moderate renal dysfunction, low body weight, and select drug interactions. However, dose-adjusted DOAC therapy is often prescribed in a dose that is lower than package insert recommendations 6.
Key Findings
- Reduced-dose apixaban is recommended in patients fulfilling 2 of 3 criteria: age ≥80 years, body weight ≤60 kg, and serum creatinine ≥1.5 mg/dL 3.
- The 5 mg twice daily dose of apixaban is safe, efficacious, and appropriate for patients with only 1 dose-reduction criterion 7.
- The types or combinations of the three apixaban dose reduction criteria do not have a significant impact on effectiveness and safety in Japanese elderly AF patients receiving on-label dose of apixaban 4.
- Off-label reduced dosing of apixaban is common in older adults with nonvalvular atrial fibrillation, but no significant association was found between empiric off-label reduced dosing and stroke or bleeding outcomes 5.