Fenoglide – The Lowest-Dose Fenofibrate Tablet for High Cholesterol

Fenoglide Dosing Information – The Lowest-Dose Fenofibrate

Fenoglide, available in 40mg and 120mg tablets, offers once-daily dosing with the lowest dose of fenofibrate. Fenoglide has the efficacy and safety that you expect without high levels of fenofibrate.

Once-Daily Dosing

In Patients with Administer
Primary hyperlipidemia or mixed dyslipidemia 120 mg once daily
Hypertriglyceridemia 40 mg to 120 mg once daily
Elderly patients and/or impaired renal function 40 mg once daily
To increase absorption of Fenoglide, take with food.

The maximum daily dose of Fenoglide is 120 mg.

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. 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.