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Eliquis® (apixaban)

Risk Minimisation Information for Healthcare Professionals

Therapy management and coagulation test when using apixaban1,2

Routine clinical monitoring is not required with apixaban treatment. However, a calibrated quantitative anti-Factor Xa assay may be useful in exceptional situations where knowledge of apixaban exposure may help to inform clinical decisions, e.g. overdose and emergency surgery.

Prothrombin time (PT), INR and activated partial thromboplastin time (aPTT)

Changes observed in these clotting tests at the expected therapeutic dose are small and subject to a high degree of variability. They are not recommended to assess the pharmacodynamic effects of apixaban.

In the thrombin generation assay, apixaban reduced endogenous thrombin potential, a measure of thrombin generation in human plasma.

Anti-FXa assays

Apixaban also demonstrates anti-FXa activity as evident by reduction in FXa enzyme activity in multiple commercial anti-FXa kits; however, results differ across kits. Data from clinical studies are only available for the Rotachrom® Heparin chromogenic assay. Anti-FXa activity exhibits a close direct linear relationship with apixaban plasma concentration, reaching maximum values at the time of apixaban peak plasma concentrations. The relationship between apixaban plasma concentration and anti-FXa activity is approximately linear over a wide dose range of apixaban.

Table 1 shows the predicted steady-state exposure and anti-FXa activity for each indication. In patients taking apixaban for the prevention of VTE following hip or knee replacement surgery, the results demonstrate a less than 1.6-fold fluctuation in peak-to-trough levels. In NVAF patients taking apixaban for the prevention of stroke and systemic embolism, the results demonstrate a less than 1.7-fold fluctuation in peak-to-trough levels. In patients taking apixaban for the treatment of DVT and PE or prevention of recurrent DVT and PE, the results demonstrate a less than 2.2-fold fluctuation in peak-to-trough levels.

Predicted apixaban steady-state exposure and anti-Factor Xa activity

Table 1 - Click below for more information.

This Prescriber Guide is not a substitute for the apixaban Summary of Product Characteristics (SmPC). Please consult the SmPC for full prescribing information.