Trilipix Drug Interactions

Oral Anticoagulants: Caution should be exercised when Trilipix is given in conjunction with oral coumarin anticoagulants. Trilipix may potentiate the anticoagulant effects of these agents resulting in prolongation of the prothrombin time/INR. Frequent monitoring of prothrombin time/INR and dose adjustment of the oral anticoagulant are recommended until the prothrombin time/INR has stabilized in order to prevent bleeding complications.
Cyclosporine: Because cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of drugs of the fibrate class including Trilipix, there is a risk that an interaction will lead to decline of renal function. The benefits and risks of using Trilipix with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.
Statins: The risk of serious muscle toxicity may be increased if fenofibrate or fenofibric acid is used concomitantly with HMG-CoA reductase inhibitors. Such combination therapy should be used with caution and patients monitored closely for signs of muscle toxicity (see Precautions). Specific studies in healthy volunteers have demonstrated the absence of clinically relevant pharmacokinetic interaction with lipid lowering agents eg, HMG-CoA reductase inhibitors (atorvastatin, fluvastatin, pravastatin, rosuvastatin and simvastatin) and ezetimibe, however, a pharmacodynamic interaction cannot be excluded. No dosing adjustment is then required for Trilipix or the co-administered drugs.
Oral Hypoglycaemic Agents: In healthy volunteers, no clinically relevant pharmacokinetic interactions have been shown between fenofibrate or fenofibric acid and rosiglitazone, metformin or glimepiride. No dosing adjustment is required for Trilipix or the co-administered drugs.
Gastrointestinal Agents: In healthy volunteers, no clinically relevant pharmacokinetic interactions have been shown between fenofibrate or fenofibric acid and omeprazole.
In vitro studies using human liver microsomes indicate that fenofibric acid is not an inhibitor of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. It is a weak inhibitor of CYP2C8, CYP2C19 and CYP2A6, and mild-to-moderate inhibitor of CYP2C9 at therapeutic concentrations.