FENOGLIDE is a fenofibrate prescribed to treat adults with hyperlipidemia (high cholesterol in the blood), mixed dyslipidemia (a combination of high low-density lipoprotein [LDL] cholesterol, high triglycerides, and low high-density lipoprotein [HDL] cholesterol), or hypertriglyceridemia (high triglyceride levels in the blood) in combination with eating a healthy diet low in saturated fat and cholesterol.

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FENOGLIDE is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet to:

• Reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
• Treat adult patients with severe hypertriglyceridemia.

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

• Primary hypercholesterolemia or mixed dyslipidemia: 120 mg per day
• Severe hypertriglyceridemia: 40 to 120 mg per day; adjust dose according to patient response
• Renally impaired patients: Initial dose of 40 mg per day; adjust dose according to effect on renal function and lipid levels
• Geriatric patients: Select dose based on renal function

To increase absorption of FENOGLIDE, take with food. Do not crush, dissolve, or chew tablets.

CONTRAINDICTIONS

FENOGLIDE is contraindicated in patients

• with severe renal dysfunction, including patients receiving dialysis
• with active liver disease
• with gallbladder disease
• who are nursing mothers
• with known hypersensitivity to fenofibrate

WARNINGS AND PRECAUTIONS

• Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risk for serious muscle toxicity is increased when fibrates are co-administered with a statin (with a significantly higher rate observed for gemfibrozil), particularly in elderly patients and in patients with diabetes, renal failure, or hypothyroidism. Risk of serious muscle toxicity also reported when fenofibrate is co-administered with colchicine.
• Fenofibrate can increase serum transaminases. Monitor liver tests, including ALT, periodically during therapy.
• Fenofibrate can reversibly increase serum creatinine levels. Monitor renal functions periodically in patients with renal impairment.
• Fenofibrate increases cholesterol excretion into the bible, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated.
• Exercise caution in concomitant treatment with coumarin anticoagulants. Adjust the dose of coumarin to maintain the prothrombin time (PT)/INR at the desired level to prevent bleeding complications.

ADVERSE REACTIONS

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

DRUG INTERACTIONS

• Coumarin anticoagulants: Fenofibrate may warrant monitoring for increases in INR/prothrombin time.
• Immunosuppressants: May decrease renal elimination of fenofibrate.
• Bile-Acid Binding Resins: May interfere with fenofibrate absorption.
• Colchicine: May increase risk of myopathy and rhabdomyolysis when taken concurrently with fenofibrate.

USE IN SPECIFIC POPULATIONS

• Geriatric Use: Determine dose selection on the basis of renal function.
• Renal impairment: Avoid in patients with severe renal impairment. Dose reduction is required in patients with mild to moderate renal impairment.

This Important Safety Information does not include all the information needed to use FENOGLIDE safely and effectively. See accompanying Full Prescibing Information for FENOGLIDE for additional information.

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Your healthcare professional can give you more information about FENOGLIDE or call 1-888-778-0887. Ask your healthcare professional if FENOGLIDE may be right for you.

To report a Product Adverse Event or Product Complaint: 1-888-778-0887, Monday-Friday, 9:00 am-7:00 pm Eastern Time

Note: 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.

Reference: Data on file, Santarus, Inc.