From the Guidelines
Apixaban should be dosed at 5 mg twice daily for most patients, but a reduced dose of 2.5 mg twice daily is recommended for patients with 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 1. The dosing of apixaban is crucial for its effectiveness and safety in patients with atrial fibrillation.
- The recommended dose of apixaban is 5 mg twice daily for patients with a creatinine clearance (CrCl) >15 mL/min, unless they meet the criteria for dose reduction 1.
- Patients with severe renal impairment (CrCl 15-30 mL/min) should receive 2.5 mg twice daily, but this dose is not based on a pivotal clinical trial, as indicated by the gray area in the guideline table 1.
- The dose reduction criteria are based on the ARISTOTLE trial, which excluded patients with a creatinine >2.5 mg/dL or a calculated CrCl <25 mL/min 1.
- It is essential to consider non-renal factors, such as drug interactions, when determining the appropriate dose of apixaban 1.
- The medication should be taken at approximately 12-hour intervals, with or without food, to maintain its efficacy in preventing thromboembolic events 1.
From the FDA Drug Label
2.1 Recommended Dose Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation 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 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery The recommended dose of apixaban tablets is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery. • In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days. • In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days Treatment of DVT and PE The recommended dose of apixaban tablets is 10 mg taken orally twice daily for the first 7 days of therapy. After 7 days, the recommended dose is 5 mg taken orally twice daily. Reduction in the Risk of Recurrence of DVT and PE 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
The dosing of apixaban varies based on the indication and patient characteristics.
- For most patients with nonvalvular atrial fibrillation, the recommended dose is 5 mg twice daily.
- For patients with at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL, the recommended dose is 2.5 mg twice daily.
- For prophylaxis of deep vein thrombosis following hip or knee replacement surgery, the recommended dose is 2.5 mg twice daily.
- For treatment of DVT and PE, the recommended dose is 10 mg twice daily for the first 7 days, then 5 mg twice daily.
- For reduction in the risk of recurrence of DVT and PE, the recommended dose is 2.5 mg twice daily after at least 6 months of treatment 2.
From the Research
Apixaban Dosing Regimens
- Apixaban is typically administered twice daily, with dosing regimens based on studies for the prevention or treatment of venous thromboembolism or acute coronary syndrome 3.
- The standard dose of apixaban is 5mg twice daily, but a reduced dose of 2.5mg twice daily may be used in certain patients, such as those with severe renal impairment or body weight less than 60kg 4.
- In patients with non-valvular atrial fibrillation, apixaban may be prescribed at a dose of 5mg twice daily, with a reduced dose of 2.5mg twice daily in patients with at least two of the following characteristics: age greater than or equal to 80 years, body weight less than 60kg, or serum creatinine greater than or equal to 1.5mg/dL 5.
Factors Influencing Apixaban Dosing
- Renal function is an important factor in determining apixaban dosing, with reduced doses recommended in patients with severe renal impairment 6.
- Age and body weight are also important factors, with reduced doses recommended in elderly patients or those with low body weight 5.
- The presence of bleeding risk factors, such as history of bleeding or concomitant use of antiplatelet agents, may also influence apixaban dosing 3.
Clinical Evidence for Apixaban Dosing
- Clinical trials have demonstrated the efficacy and safety of apixaban in preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation, with a dosing regimen of 5mg twice daily 7.
- Registry studies have shown that apixaban may be effective in reducing the risk of stroke in patients with severe chronic kidney disease, although the optimal dosing regimen in this population is uncertain 6.
- Extended anticoagulation with apixaban has been shown to reduce the risk of recurrent venous thromboembolism without increasing the rate of major bleeding, with a dosing regimen of 2.5mg twice daily 4.