Is apixaban (Eliquis) appropriate for a patient with impaired renal function on dialysis?

From the Guidelines

Eliquis (apixaban) is not recommended for patients on dialysis due to limited clinical data supporting its safety and efficacy in this population, and the potential for increased bleeding risk. For patients with end-stage renal disease requiring dialysis, other anticoagulants like warfarin are typically preferred 1. The concern with Eliquis in dialysis patients stems from potential drug accumulation since the medication is partially cleared by the kidneys, which could increase bleeding risk. Additionally, dialysis itself only removes a small amount of the drug from the bloodstream.

Some key points to consider when evaluating the use of Eliquis in dialysis patients include:

• The FDA label for Eliquis was updated to include a reduced dose of 5 mg twice daily for dialysis patients, but there remains limited clinical data supporting its safety and efficacy in this population 1.
• The European Medical Agency has not endorsed the use of Eliquis in dialysis patients, and the NCCN Panel acknowledges that there are insufficient data to support safe apixaban dosing in these patients, especially those who are on hemodialysis 1.
• Other anticoagulants, such as warfarin, may be preferred for patients with end-stage renal disease requiring dialysis, due to their more established safety and efficacy profiles in this population 1.
• If anticoagulation is needed for a dialysis patient, consultation with both nephrology and cardiology specialists is strongly recommended to determine the most appropriate anticoagulant choice based on the individual's specific clinical situation, bleeding risk, and indication for anticoagulation.

Regular monitoring of the patient's clinical status would be essential if Eliquis were to be used in this setting, due to the potential for increased bleeding risk and the limited clinical data available to support its use in dialysis patients 1.

From the FDA Drug Label

Clinical efficacy and safety studies with apixaban did not enroll patients with end-stage renal disease (ESRD) on dialysis. In patients with ESRD maintained on intermittent hemodialysis, administration of apixaban at the usually recommended dose [see Dosage and Administration (2. 1)] will result in concentrations of apixaban and pharmacodynamic activity similar to those observed in the ARISTOTLE study [see Clinical Pharmacology (12. 3)]. 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 No dose adjustment is recommended for patients with renal impairment, including those with ESRD on dialysis [see Dosage and Administration (2. 1)].

Apixaban use in patients on dialysis: The use of apixaban in patients with end-stage renal disease (ESRD) on dialysis is not well established, as these patients were not included in clinical efficacy and safety studies.

• Dosing: No dose adjustment is recommended for patients with renal impairment, including those with ESRD on dialysis.
• Efficacy and Safety: It is not known whether the concentrations of apixaban achieved in patients with ESRD on dialysis will lead to similar stroke reduction and bleeding risk as seen in clinical trials. 2

From the Research

Apixaban Use in Patients on Dialysis

• Apixaban appears to be a reasonable alternative to warfarin in patients with severe renal impairment, including those on dialysis 3.
• Studies have shown that apixaban may be superior to warfarin in terms of major bleeding rates in patients with end-stage renal disease (ESRD) on hemodialysis 4, 5.
• A national cohort study found that apixaban was associated with a lower risk of major bleeding, intracranial bleeding, and gastrointestinal bleeding compared to warfarin in patients with ESKD on dialysis 5.
• However, there is variability in apixaban prescribing practices for the treatment of venous thromboembolism (VTE) in dialysis patients, suggesting a need for prospective studies and updated dosing guidance 6.

Safety and Efficacy of Apixaban in Peritoneal Dialysis

• Limited studies have evaluated the safety and efficacy of apixaban in patients receiving peritoneal dialysis (PD), but available data suggest that it may be safe and effective 7.
• More studies are needed to better assess the use of apixaban in the PD population, particularly in terms of pharmacokinetics and pharmacodynamics 7.

Key Findings

• Apixaban may be a safer alternative to warfarin in patients with severe renal impairment, including those on dialysis 3, 4, 5.
• Variability in apixaban prescribing practices highlights the need for further research and guidance 6.
• Limited data suggest that apixaban may be safe and effective in patients receiving peritoneal dialysis, but more studies are needed 7.