Primary Hypercholesterolemia and Mixed Dyslipidemia: ANTARA® is indicated as 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 adult patients with primary hyperlipidemia or mixed dyslipidemia.
Hypertriglyceridemia: ANTARA® is also indicated as adjunctive therapy to diet for treatment of
adult patients with hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce
fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum
triglycerides (eg, >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has
not been adequately studied.
Important limitations of use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2
IMPORTANT SAFETY INFORMATION
ANTARA® is contraindicated in patients with severe renal impairment; active liver disease, including
unexplained persistent liver function abnormalities; preexisting gallbladder disease; nursing mothers; and hypersensitivity to fenofibric acid,
choline fenofibrate or fenofibrate.
The effect of ANTARA® on coronary heart disease morbidity and mortality and non-cardiovascular mortality
has not been established.
Fibrates increase the risk for myopathy and are associated with rhabdomyolysis. The risks for myopathy and rhabdomyolysis are increased when
fibrates are co-administered with a statin, particularly in the elderly and in patients with diabetes, renal failure, or hypothyroidism. The
combined use of fibrates and statins should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the
Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness. Discontinue ANTARA®
if myopathy/myositis is suspected or diagnosed or if CPK levels are markedly elevated.
Fenofibrate at doses equivalent to 90 mg ANTARA® per day can increase serum transaminases. Monitor
liver function regularly and discontinue treatment if enzyme levels persist above 3 times the normal limit.
Fenofibrate can reversibly elevate serum creatinine. Monitor renal function in patients with renal impairment.
Fenofibrate may lead to cholelithiasis. Discontinue ANTARA® if gallstones are found.
ANTARA® can potentiate the activity of oral anticoagulants. Monitoring and dosage adjustment of
anticoagulants as needed are recommended.
Other precautions include pancreatitis, hematologic changes, hypersensitivity reactions, and venothromboembolic events.
The most common adverse reactions (>2% and ≥1% greater than placebo) are abnormal liver function tests, increased AST, increased ALT,
increased CPK, and rhinitis.
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