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Hyperlipidemia and Mixed Dyslipidemia
FENOGLIDE is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological intervention alone has been inadequate.

Hypertriglyceridemia
FENOGLIDE is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. Improving glycemic control in diabetic patients showing a fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia, thereby obviating the need for pharmacologic intervention.

General Guidelines
FENOGLIDE was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus. Markedly elevated levels of serum triglycerides (eg, >2000 mg/dL) may increase the risk of developing pancreatitis. The effect of FENOGLIDE therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low-density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing these patients from those with elevated VLDL.

The dosage and administration of FENOGLIDE is as follows:

• Primary hyperlipidemia and mixed dyslipidemia: 120 mg/day
• Hypertriglyceridemia: 40 to 120 mg/day; the dose should be adjusted according to patient response
• Renally impaired patients: 40 mg/day; the dose should be increased according to the effect on renal function and lipid levels

To increase absorption of FENOGLIDE, take with food.

FENOGLIDE is contraindicated in patients with severe renal dysfunction, including those receiving dialysis, active liver disease, gallbladder disease, nursing mothers, and in patients with known hypersensitivity to fenofibrate.

Fenofibrate may increase serum transaminases. Regular periodic liver tests should be performed, and therapy discontinued if enzyme levels persist >3 times the normal limit.

Fenofibrate may lead to cholelithiasis (gallstones). If cholelithiasis is suspected, gallbladder studies are indicated. Discontinue FENOGLIDE if gallstones are found.

Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal failure, or hypothyroidism.

Fenofibrate reversibly increases serum creatinine levels.

The most common adverse reactions (>2% and at least 1% greater than placebo) are abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis.

Potential drug-drug interactions can occur with cyclosporine, HMG-CoA reductase inhibitors, and bile-acid resins. Exercise caution in concomitant treatment with coumarin anticoagulants. Reduce the dosage of coumarin to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. Please refer to the Full Prescribing Information for additional information.

Fenofibrate should be avoided in patients with severe renal impairment and dose reduction is required in patients with mild-to-moderate renal impairment. Dose selection for the elderly should be made on the basis of renal function.

Click here for Full Prescribing Information

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