Indicated for:

Primary Hypercholesterolemia and Mixed Dyslipidemia:

• 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.

Severe Hypertriglyceridemia:

• As adjunctive therapy to diet for for treatment of adult patients with severe 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 (e.g > 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.

Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.

Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 90 mg once daily.

The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

Antara is contraindicated in patients with:

• Severe renal dysfunction, including patients receiving dialysis
• Active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities
• Pre-existing gallbladder disease 
• Nursing mothers 

Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risk for serious muscle toxicity appears to be increased when fenofibrate is co-administered with a statin (with a significantly higher rate observed with gemfibrozil), particularly in elderly patients and in patients with diabetes, renal failure, or hypothyroidism.

Hepatocellular, chronic active and cholestatic hepatitis associated 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.

Elevations in serum creatinine have been reported in patients on fenofibrate.

Pancreatitis has been reported in patients taking fenofibrate, gemfibrozil, and clofibrate.

Fenofibrate, like clofibrate and gemfibrozil, may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Antara therapy should be discontinued if gallstones are found.

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.

Mild to moderate hemoglobin, hematocrit, and white blood cell decreases have been observed in patients following initiation of fenofibrate therapy. However, these levels stabilize during long-term administration. Thrombocytopenia and agranulocytosis have been reported in individuals treated with fenofibrate. Periodic monitoring of red and white blood cell counts are recommended during the first 12 months of Antara administration.

In the FIELD trial, 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.

Caution should be exercised when anticoagulants are given in conjunction with Antara because of the potentiation of coumarin-type anticoagulants in prolonging the prothrombin time/International Normalized Ratio (PT/INR). To prevent bleeding complications, frequent monitoring of PT/INR and dose adjustment of the anticoagulant are recommended until PT/INR has stabilized.

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

Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decrease in creatinine clearance and because renal excretion is the primary elimination route of fibrate drugs including Antara, there is a risk that an interaction will lead to deterioration of renal function.

Cases of myopathy, including rhabdomyolysis, have been reported with fenofibrates co-administered with colchicine, and caution should be exercised when prescribing fenofibrate with colchicine.

Safety in pregnant women has not been established.

Fenofibrate should not be used in nursing mothers.

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• Dosage greater than 90 mg per day for treatment of severe hypertriglyceridemia. GoToSource

• Use in patients under the age of 18. GoToSource

• Diabetic retinopathy. GoToSource

• Rheumatoid arthritis. GoToSource

• Autoimmune hepatitis. GoToSource

• Asymptomatic primary biliary cirrhosis. GoToSource

• Reduce neurological deficit, edema and cerebral lesion with traumatic brain injury. GoToSource

• Hyperuricemia and gout. GoToSource

Acute pancreatitis. GoToSource

Rhabdomyolysis (breakdown of muscle tissue). GoToSource

Nephrotoxicity (damage to kidneys). GoToSource

Increased risk of myopathy (disorder of the skeletal muscles) when used with statins. GoToSource 

Pulmonary embolus (blockage in one of the pulmonary arteries in lungs) and deep vein thrombosis (blood clot within one or more of deep veins). GoToSource

Acute generalized exanthematous pustulosis (severe skin eruption). GoToSource

Anemia (deficiency of red blood cells) and neutropenia (low level of type of white blood cell). GoToSource

Acute cholestatic hepatitis (obstruction of bile secretion). GoToSource

No major injury lawsuits reported.