AMPLIFY Study
The mean duration of exposure to ELIQUIS (apixaban) was 154 days and to enoxaparin/
warfarin was 152 days in the AMPLIFY study. Adverse reactions related to bleeding
occurred in 417 (15.6%) ELIQUIS-treated patients compared to 661 (24.6%) enoxaparin/
warfarin-treated patients. The discontinuation rate due to bleeding events was 0.7% in the
ELIQUIS-treated patients compared to 1.7% in enoxaparin/warfarin-treated patients in the
AMPLIFY study.
For patients receiving ELIQUIS (apixaban) at a dose of 2.5 mg twice daily, avoid
coadministration with strong dual inhibitors of CYP3A4 and P-gp [see Dosage and
Administration (2.2) and Clinical Pharmacology (12.3) in full Prescribing Information].
Strong Dual Inducers of CYP3A4 and P-gp
Avoid concomitant use of ELIQUIS with strong dual inducers of CYP3A4 and P-gp
(e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrea ͔)