Fenoglide Fenofibrate Tablet for High Cholesterol

Fenoglide is a prescription medication. Talk to your doctor about Fenoglide to find out whether it's right for you, and read through the frequently asked questions below to learn more about this treatment for high cholesterol.

What are Fenoglide tablets?

Fenoglide is a prescription tablet to treat adults with 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.

Why is my doctor prescribing Fenoglide?

Your doctor has prescribed Fenoglide because you have high cholesterol and/or high triglyceride levels. In clinical trials, Fenoglide has been shown to help improve the lipid (fat) profile by lowering triglyceride levels, lowering LDL (bad) cholesterol, lowering total cholesterol, and lowering Apo B (a structural component of cholesterol). In addition, Fenoglide has also been shown to raise HDL (good) cholesterol. Your doctor may have also placed you on a healthy diet prior to prescribing Fenoglide. For best results, it is important that you maintain a healthy diet low in saturated fat and cholesterol while taking Fenoglide.

Is Fenoglide safe to take?

Fenoglide is approved for use by the U.S. Food and Drug Administration (FDA). Clinical studies have shown that five percent of patients stopped taking fenofibrates because of adverse side effects compared to three percent of patients who took placebo (sugar pill). The most common side effects were abnormal liver function tests; respiratory disorder; abdominal pain, back pain, and headache. If, for any reason, you experience any side effects, especially soreness in your muscles, it is important to talk to your doctor.

Is there anyone with high cholesterol who should not take Fenoglide tablets?

Fenoglide may not be right for everyone. Fenoglide should not be taken if you have serious liver disease, kidney disease, or gallbladder disease. If you are allergic or sensitive to fenofibrates, or are a nursing mother, you should not take Fenoglide. Advise your doctor if you have or believe you have any of these conditions.

If I am on other drugs, can I still take Fenoglide?

You should let your doctor know if you are taking any other drugs while taking Fenoglide. Caution should be taken when taking Fenoglide with coumarin anticoagulants (drugs that help prevent blood clotting). Using these two types of medications together can sometimes cause serious side effects. If you are currently taking an HMG-CoA reductase inhibitor (statin), you should talk to your doctor about the benefits and risks of taking Fenoglide. Combined use of Fenoglide with an HMG-CoA reductase inhibitor (statin) should be avoided unless the benefit of further alteration in lipid (fat) levels is likely to outweigh the potential increased risk of this drug combination. Your doctor will determine whether the combination of Fenoglide and a statin is right for you. Click here for full Prescribing Information.

How should Fenoglide be taken?

Fenoglide tablets should be taken with meals. Fenoglide should be taken one time per day, at any time of the day. It is important to take Fenoglide exactly as it is prescribed by your doctor.

How will I know whether Fenoglide is working?

While you are taking Fenoglide, your doctor will take a blood sample and check your lipid (fat) levels during a follow-up visit to make sure that Fenoglide is working for you. As long as you are taking Fenoglide, it is important for you to continue to eat healthily to help control your cholesterol and triglyceride levels.

Am I at risk for high cholesterol and triglyceride levels?

Some of the known factors that lead to high levels of cholesterol and triglycerides and therefore increase your risk of developing heart disease are:1
DIET - Foods that are high in cholesterol, saturated fat, and trans fat increase cholesterol levels. Cutting down on the amount of meat, butter, and cheese that you consume and eating more whole grains, vegetables, and fish can help reduce your risk.

What can I do to reduce my risk?

Education and lifestyle changes, such as a healthy diet and exercise, may help to lower your cholesterol and reduce other risk factors that can often lead to heart disease and stroke.2 Here are some goals that you can set in order to lower your cholesterol and triglyceride levels:3

Sometimes, though, even eating right and exercising regularly may not be enough to lower high cholesterol and triglyceride levels. If that is the case, your doctor may prescribe Fenoglide tablets or other drugs to treat the condition.

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.

References:

  1. National Heart, Lung, and Blood Institute Website. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/Hbc/HBC_Causes.html. Accessed September 29, 2009.
  2. American Heart Association Website. Available at: http://www.americanheart.org/presenter.jhtml?identifier=3046113. Accessed September 29, 2009.
  3. MayoClinic.com Website. Available at: http://www.mayoclinic.com/health/high-blood-cholesterol/DS00178/DSECTION=9. Accessed September 29, 2009.