Fenoglide Fenofibrate Tablet for High Cholesterol

Indications

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 non-pharmacological interventions 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 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 patients with type 2 diabetes. Markedly elevated levels of serum triglycerides (e.g. > 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.

Important Safety Information

Fenoglide administration is contraindicated in patients with: known hypersensitivity to fenofibrate or any of the formulation components; severely impaired renal function including dialysis patients; gallbladder disease; active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormality; and nursing mothers.

Fenofibrate can 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 (gall stones). If cholelithiasis is confirmed, Fenoglide should be discontinued. Patients should take Fenoglide at least 1 hour before or 4-6 hours after a bile acid binding resin.

Fenoglide may increase the effects of coumarin-type anticoagulants. Dosage adjustment based on frequent prothrombin time/International Normalized Ratio determinations is advisable.

The combined use of Fenoglide 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.

Treatment with fenofibrate increases risk of myopathy. Treatment with fenofibrate increases risk of rhabdomyolysis. Muscle pain, tenderness, or weakness warrants prompt medical evaluation. Discontinue Fenoglide if markedly elevated CPK levels occur or myopathy/myositis is suspected or diagnosed.

The effect of Fenoglide on coronary heart disease morbidity and mortality, and noncardiovascular mortality has not been established.

Due to the potential risk for deterioration of renal function, the combined use of fenofibrates with immunosuppressants, cyclosporine, and other potentially nephrotoxic agents should be carefully considered and the lowest effective dose of fenofibrate employed. Fenofibrate should be avoided in patients with severely impaired renal function including dialysis patients.

Other adverse events include: pancreatitis, hypersensitivity reactions, and mild to moderate hematologic changes. Adverse events most frequently observed in clinical trials: abnormal liver tests; respiratory disorder; abdominal pain; back pain; and headache.

Click here for Full Prescribing Information.

Your healthcare professional can give you more information about Fenoglide or call 1-800-849-9707 ext. 1454. Ask your healthcare professional if Fenoglide may be right for you.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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