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Increased mean AUC & Cmax with strong CYP3A4 & P-gp inhibitors (eg, ketoconazole). Increased plasma concentration with diltiazem, naproxen, clarithromycin, amiodarone, verapamil, quinidine. Decreased mean AUC & Cmax with strong CYP3A4 & P-gp inducers (eg, rifampin). Reduced plasma concentration with other strong CYP3A4 & P-gp inducers (eg, phenytoin, carbamazepine, phenobarbital or St. John's Wort). Additive effect on anti-FXa activity with enoxaparin. Increased bleeding risk with NSAIDs, ASA or P2Y12 inhibitors. Agents associated with serious bleeding eg, unfractionated heparins & heparin derivatives (including LMWH), FXa inhibiting oligosaccharides (eg, fondaparinux), direct thrombin II inhibitors (eg, desirudin), thrombolytic agents, GPIIb/IIIa receptor antagonists, dipyridamole, dextran, sulfinpyrazone, vit K antagonists, & other oral anticoagulants.
Strong Dual Inhibitors of CYP3A4 and P-gp: For patients receiving apixaban 5 mg or 10 mg twice daily, the dose of apixaban should be decreased by 50% when coadministered with drugs that are strong dual inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin).
Strong Dual Inducers of CYP3A4 and P-gp: Avoid concomitant use of apixaban with strong dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John's wort) because such drugs will decrease exposure to apixaban.
Anticoagulants and Antiplatelet Agents: Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding.
Undesirable effects: The safety of apixaban has been investigated in 7 Phase III clinical studies including more than 21,000 patients: more than 5,000 patients in venous thromboembolic event prevention (VTEp) studies, more than 11,000 patients in non-valvular atrial fibrillation (NVAF) studies and more than 4,000 patients in the venous thromboembolic event treatment (VTEt) studies, for an average total exposure of 20 days, 1.7 years and 221 days respectively.
