Indications and Important Safety Information About TriCor

TriCor Type IIa/IIb Indications

• TriCor is indicated as adjunctive therapy to diet in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb) to: increase high-density lipoprotein cholesterol (HDL-C), reduce triglycerides (TG), reduce low-density lipoprotein cholesterol (LDL-C), reduce total cholesterol (Total-C), reduce apolipoprotein B (Apo B).
• Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.

TriCor Type IV/V Indications

• TriCor is indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia). Improving glycemic control in diabetic patients with fasting chylomicronemia usually obviates the need for drug therapy.
• The effect of TriCor on pancreatitis risk reduction in patients with markedly elevated serum TG has not been adequately studied.
• Drug therapy is not indicated for patients with type I hyperlipoproteinemia.
• The use of TriCor should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods such as diet, exercise, and reduction of alcohol intake. If the decision is made to use TriCor, the patient should be instructed that this does not reduce the importance of adhering to diet. Diseases or drugs which contribute to hyperlipidemia should be evaluated and appropriate interventions begun.

Important Safety Information

• TriCor is contraindicated in patients with: hypersensitivity to fenofibrate; hepatic or severe renal dysfunction including primary biliary cirrhosis; unexplained persistent liver function abnormality; and preexisting gallbladder disease.
• Fenofibrate has been associated with increases in serum transaminases. Regular liver function monitoring should be performed, and therapy discontinued if enzyme levels persist >3 times the normal limit.
• Fenofibrate may lead to cholelithiasis. If cholelithiasis is confirmed, TriCor should be discontinued.
• TriCor may increase the effects of coumarin-type anticoagulants. Dosage adjustment based on frequent prothrombin time/INR determinations is advisable.
• The combined use of TriCor and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk. This combination has been associated with rhabdomyolysis, markedly elevated creatine kinase levels and myoglobinuria, leading to acute renal failure.
• TriCor may occasionally be associated with myositis, myopathy, or rhabdomyolysis. Muscle pain, tenderness, or weakness should have prompt medical evaluation. Discontinue TriCor if markedly elevated CPK levels occur or myopathy/myositis is suspected or diagnosed.
• The effect of TriCor on coronary heart disease morbidity and mortality and noncardiovascular mortality has not been established.
• Other precautions include increases in serum creatinine that tend to be reversible, pancreatitis, hypersensitivity reactions, venothromboembolic events, and hematologic changes.
• Adverse events most frequently observed in clinical trials: abnormal liver function tests; respiratory disorder; abdominal pain; back pain; and headache.

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Reference:

TriCor [package insert]. North Chicago, IL: Abbott Laboratories.

Prescribing Information

Full U.S. Prescribing Information:

 Download TRICOR® 48 mg and 145 mg (fenofibrate tablets) Prescribing Information

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