Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- *Table 1 (Bleeding events) and Figure 1 modified
USE IN SPECIFIC POPULATIONS
- No dose adjustment is recommended for patients with renal impairment alone, including those with end-stage renal disease (ESRD) maintained on hemodialysis, except nonvalvular atrial fibrillation patients who meet the criteria for dosage adjustment.
- Patients with ESRD (CrCl <15 mL/min) receiving or not receiving hemodialysis were not studied in clinical efficacy and safety studies with ELIQUIS; therefore, the dosing recommendations are based on pharmacokinetic and pharmacodynamic (anti-Factor Xa activity) data in subjects with ESRD maintained on dialysis
- No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh class A). Because patients with moderate hepatic impairment (Child-Pugh class B) may have intrinsic coagulation abnormalities and there is limited clinical experience with ELIQUIS in these patients, dosing recommendations cannot be provided. ELIQUIS is not recommended in patients with severe hepatic impairment (Child-Pugh class C)
WARNING: PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS…
PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including Eliquis, increases the risk of thrombotic events. If anticoagulation with Eliquis is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant…
WARNINGS AND PRECAUTIONS
Increased Risk of Thrombotic Events after Premature Discontinuation
- Premature discontinuation of any oral anticoagulant, including Eliquis, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Eliquis to warfarin in clinical trials in atrial fibrillation patients. If Eliquis is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
8 USE IN SPECIFIC POPULATIONS
8.6 End-Stage Renal Disease Patients Maintained with Hemodialysis
- new subsection added
note: also changes to DOSAGE AND ADMINISTRATION, 2.7 Renal Impairment