Important Safety Information and Indications for TRILIPIX^®

Important Safety Information for TRILIPIX

• TRILIPIX is contraindicated in patients with severe renal impairment; active liver disease, including those with unexplained persistent liver function abnormalities; gallbladder disease; in nursing mothers; and in patients with hypersensitivity to fenofibric acid or fenofibrate.
• Fibrate and statin monotherapy increase the risk of myositis or myopathy and have been associated with rhabdomyolysis. The risks for myopathy and rhabdomyolysis are increased when fibrates are coadministered with a statin, particularly in the elderly and in patients with diabetes, renal failure, or hypothyroidism.
• Tell patients to promptly report unexplained muscle pain, tenderness, or weakness. If markedly elevated CPK levels occur or myopathy/myositis is diagnosed, TRILIPIX and statin therapy should be discontinued.
• TRILIPIX can cause reversible elevations in serum creatinine. Monitor renal function periodically in patients with or at risk for renal insufficiency.
• TRILIPIX can increase serum transaminases. Monitor liver function tests regularly, and discontinue therapy if enzyme levels persist above 3 times the upper limit of normal.
• TRILIPIX may lead to cholelithiasis. If cholelithiasis is confirmed, TRILIPIX should be discontinued.
• TRILIPIX may increase the effects of oral coumarin anticoagulants. Monitoring and dosage adjustment of the anticoagulant are recommended.
• Pancreatitis, hypersensitivity reactions, hematological changes, and venothromboembolic events have been reported with the use of fibrates.
• The effect of TRILIPIX on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.
• Co-administration with the maximum dose of a statin has not been evaluated and should be avoided unless the benefits are expected to outweigh the risks.
• Adverse events reported by ≥4% of patients receiving TRILIPIX alone or co-administered with a statin in controlled clinical trials were dyspepsia, nausea, nasopharyngitis, upper respiratory tract infection, arthralgia, back pain, pain in extremity, dizziness, and headache.

Indications for TRILIPIX^® (fenofibric acid) delayed-release capsules

• Every reasonable attempt should be made to control serum lipids with diet, other disease-state management, and other non-drug methods before and during treatment with TRILIPIX.
• TRILIPIX is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.
• TRILIPIX is indicated as an adjunct to diet to reduce TG in patients with severe hypertriglyceridemia. Improving glycemic control in diabetics with fasting chylomicronemia will usually obviate the need for drug therapy. The effect of TRILIPIX on pancreatitis risk reduction in patients with markedly elevated serum TG has not been adequately studied.
• TRILIPIX is indicated as an adjunct to diet to reduce LDL-C, Total-C, TG, and Apo B and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.
• Important Limitations of Use: No incremental benefit of TRILIPIX on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of TRILIPIX was not shown to reduce coronary heart disease morbidity and mortality in 2 large trials of patients with type 2 diabetes mellitus.

Please see full Prescribing Information for TRILIPIX.