Indications and Important Safety Information You Should Know About TRILIPIX

Indications

• Every reasonable attempt should be made to control serum lipids with diet and other nonpharmacological measures prior to the use of lipid-altering agents.
  
  

• TRILIPIX^® (fenofibric acid) delayed-release capsules 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. CHD risk equivalents include other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease), diabetes, and multiple risk factors that confer a 10-year risk >20%.
  
  

• TRILIPIX is indicated as an adjunct to diet to reduce TG in patients with severe hypertriglyceridemia.
  
  

• TRILIPIX is indicated as an adjunct to diet to reduce LDL-C, Total-C, TG, and Apo B and increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.
  
  

• Limitations of Use: No incremental benefit of TRILIPIX on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established.
  
  

Important Safety Information

• TRILIPIX is contraindicated in patients with severe renal impairment, including those receiving dialysis; active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities; preexisting gallbladder disease; in nursing mothers; or in patients with hypersensitivity to fenofibric acid, choline fenofibrate or fenofibrate.
  
  

• Fibrate and statin monotherapy increase the risk of myositis or myopathy, and have been associated with rhabdomyolysis. Data from observational studies suggest that the risk for rhabdomyolysis is increased when fibrates are co-administered with a statin (with a significantly higher rate observed for gemfibrozil). The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal failure, or hypothyroidism.
  
  

• Patients should be instructed to report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise and fever. If markedly elevated CPK levels occur or myopathy/myositis is diagnosed, TRILIPIX and statin therapy should be discontinued.
  
  

• Reversible elevations in serum creatinine have been reported in patients receiving TRILIPIX as monotherapy or co-administered with statins, as well as in patients receiving fenofibrate. Renal function should be monitored in patients with or at risk for renal insufficiency.
  
  

• TRILIPIX at a dose of 135 mg once daily administered as monotherapy or co-administered with statins has been associated with increases in serum transaminases. Regular liver function monitoring should be performed for the duration of therapy with TRILIPIX, and therapy discontinued 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 potentiate the effects of oral coumarin anticoagulants. Dosage adjustment of the anticoagulant based on frequent prothrombin time/INR determinations is recommended.
  
  

• Pancreatitis, hypersensitivity reactions, hematological changes, and venothromboembolic events have been reported with the use of fibrates.
  
  

• Co-administration with the maximum dose of a statin has not been evaluated in clinical studies and should be avoided unless the benefits are expected to outweigh the risks.
  
  

• The most commonly reported adverse events (≥4% of patients receiving TRILIPIX or TRILIPIX co-administered with a statin) were dyspepsia, nausea, nasopharyngitis, upper respiratory tract infection, arthralgia, back pain, pain in extremity, dizziness, and headache. The most common adverse reactions reported by ≥3% of patients treated with fenofibrate and greater than placebo were abdominal pain, back pain, headache, abnormal liver function tests, increased CPK, and respiratory disorder.
  
  

Please see full Prescribing Information.