Hyperlipidemia and Mixed Dyslipidemia

Fenofibrate 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 non-pharmacological interventions alone has been inadequate.

Hypertriglyceridemia

Fenofibrate 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.

General Guidelines

Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus. [see Warnings and Precautions]

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.

Drug therapy is not indicated for patients with 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.²

Hyperlipidemia and Mixed Dyslipidemia

The initial dose of Fenofibrate Tablets is 120 mg per day.

Hypertriglyceridemia

The initial dose is 40 to 120 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 120 mg per day.

Renally Impaired Patients

Treatment with fenofibrate should be initiated at a dose of 40 mg/day in patients with mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibrate should be avoided in patients with severe renal function.

Elderly Patients

Dose selection for the elderly should be made on the basis of renal function. [See Use in Specific Populations.]

General Dosing Information

Fenofibrate Tablets should be taken with meals.

Dosage Forms And Strengths

• 40 mg: White to off white oval tablets. Debossed "FLO".
• 120 mg: White to off white oval tablets. Debossed "FHI".

Storage And Handling

• NDC 59630-490-30: 40 mg White to off white oval tablets. Debossed "FLO"; bottle of 30 tablets
• NDC 59630-490-10: 40 mg White to off white oval tablets. Debossed "FLO"; bottle of 100 tablets
• NDC 59630-495-30: 120 mg White to off white oval tablets. Debossed "FHI"; bottle of 30 tablets
• NDC 59630-495-10: 120 mg White to off white oval tablets. Debossed "FHI".; bottle of 100 tablet

Manufactured by: Catalent Pharma Solutions Winchester, KY 40391. FDA Rev date: 8/10/2007

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