Indicated for:

Treatment of Severe Hypertriglyceridemia:

• Adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Trilipix therapy on reducing this risk has not been adequately studied.

Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia:

• Adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.

Fenofibrate at a dose equivalent to 135 mg of Trilipix did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.

Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.

The use of Trilipix should be avoided in patients with severely impaired renal function.

Patients should be placed on an appropriate lipid-lowering diet before receiving Trilipix and should continue this diet during treatment. 

Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.

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 
• Nursing mothers

Serious drug-induced liver injury (DILI), including liver transplantation and death, have been reported postmarketing with Trilipix. DILI has been reported within the first few weeks of treatment or after several months of therapy and in some cases has reversed with discontinuation of Trilipix treatment. 

In clinical trials, Trilipix at a dose of 135 mg daily has been associated with increases in serum AST or ALT. The incidence of increases in transaminases observed with fenofibrate therapy may be dose related.

Fibrates increase the risk of myositis or myopathy and have been associated with rhabdomyolysis. The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal failure, or hypothyroidism.

The risk for rhabdomyolysis is increased when fibrates are co-administered with a statin.

Reversible elevations in serum creatinine have been reported in patients receiving Trilipix as well as patients receiving fenofibrate.

Mild to moderate hemoglobin, hematocrit, and white blood cell decreases have been observed in patients following initiation of Trilipix and fenofibrate therapy.

Hepatocellular, chronic active, and cholestatic hepatitis observed with fenofibrate therapy have been reported after exposures of weeks to several years. In extremely rare cases, cirrhosis has been reported in association with chronic active hepatitis.

Trilipix, like fenofibrate, clofibrate, and gemfibrozil, may increase cholesterol excretion into the bile, potentially leading to cholelithiasis.

Pancreatitis has been reported in patients taking drugs of the fibrate class, including Trilipix.

Thrombocytopenia and agranulocytosis have been reported in individuals treated with fenofibrates.

Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported postmarketing, occurring days to weeks after initiation of fenofibrate.

Pulmonary embolus (PE) and deep vein thrombosis (DVT) were observed at higher rates in the fenofibrate than the placebo-treated group.

There have been postmarketing and clinical trial reports of severe decreases in HDL cholesterol levels (as low as 2 mg/dL) occurring in diabetic and non-diabetic patients initiated on fibrate therapy. The decrease in HDL-C is mirrored by a decrease in apolipoprotein A1. This decrease has been reported to occur within 2 weeks to years after initiation of fibrate therapy. The HDL-C levels remain depressed until fibrate therapy has been withdrawn; the response to withdrawal of fibrate therapy is rapid and sustained. The clinical significance of this decrease in HDL-C is unknown. It is recommended that HDL-C levels be checked within the first few months after initiation of fibrate therapy. If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated.

Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine.

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/International Normalized Ratio (PT/INR).

Since bile acid binding resins may bind other drugs given concurrently, patients should take Trilipix at least 1 hour before or 4 to 6 hours after a bile acid resin to avoid impeding its absorption.

Immunosuppressants such as cyclosporine and tacrolimus 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 deterioration of renal function.

The safety of Trilipix in pregnant women has not been established. Animal studies: maternal toxicity.

Trilipix should not be used in nursing mothers.

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• Dosage greater than 135 mg once daily in patients with normal renal function. GoToSource 

• Use in patients under the age of 18. GoToSource 

• Reduce uric acid levels. GoToSource

• Diabetic retinopathy. GoToSource

Rhabdomyolysis (destruction of muscle tissue). GoToSource

Increased liver-enzyme levels. GoToSource

Increased serum creatinine levels (indicating impaired kidney function or kidney disease). GoToSource

Hepatitis, myositis (inflammation of muscles) and rash. GoToSource

Gallstones. GoToSource

Gynecomastia (male breast enlargement). GoToSource

Pancreatitis (inflammation of pancreas). GoToSource

Venous thromboembolism. GoToSource

Lawsuits filed for rh­abdomyolysis, pancreatitis, liver and kidney injury, blood clots and stevens-johnson syndrome.