ANTARA® Patient Information

ANTARA® and Your Diet

Talk with your doctor about a cholesterol-lowering diet prior to being prescribed ANTARA® (fenofibrate capsules) 90 mg. You should continue this diet during treatment with ANTARA®.  ANTARA® can be taken without regard to meals.

ANTARA® and Dosing

Your kidneys are your body’s main way of removing ANTARA® from your system. If you have reduced kidney function, your ANTARA® treatment should start at a dosage of 30 mg/day. If you are elderly, you should also be started at a dosage of 30 mg/day. Speak to your doctor about your health and dosing amounts that are right for you.

Who Should Not Take ANTARA®?

ANTARA®, as with any fenofibrate, should not be used by people who are sensitive to a fenofibrate. As with any fenofibrate, ANTARA® should not be used by people with liver problems, gallbladder problems, or severe kidney disease.

Fenofibrates and Checking Your Liver Function

Fenofibrates may be associated with increasing certain liver enzymes found in the blood. These enzymes are called serum transaminases. Your doctor should monitor your liver function regularly. If your levels continue to be 3 times higher than the normal limit, your cholesterol-lowering treatment with ANTARA® should be stopped. Ask your doctor about your liver function and at what intervals you should have it checked.

Fenofibrates in combination with a Statin Medication

Taking ANTARA®, as with any fenofibrate, while also taking a statin medication (HMG-CoA reductase inhibitor) should be avoided unless you and your doctor decide the benefits outweigh the risks. There have been reports of skeletal muscle disease, muscle contraction problems, and muscle protein being excreted in urine. Speak to your doctor if you are taking a statin. Using a fibrate alone, even without a statin, can occasionally result in muscle inflammation and skeletal muscle disorders. If you experience any type of muscle pain, tenderness, or weakness, contact your doctor immediately.

Fenofibrates and Gallstones

In some instances, fenofibrates may lead to gallstones.

ANTARA® and Pregnancy

There are no adequate or well-controlled studies of ANTARA® in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Inform your doctor if you are pregnant or are considering getting pregnant while on a course of treatment with ANTARA®.

ANTARA® and Heart Disease

The effect of ANTARA® on heart disease and the sickness or death resulting from heart disease has not been evaluated. Fenofibrate, the active ingredient in ANTARA®, was not shown to reduce sickness or death due to heart disease in patients with type 2 diabetes mellitus (T2DM).

ANTARA® and Other Possible Drug Interactions

Use of ANTARA® may increase the effects of blood thinners, such as Coumadin® (warfarin sodium). Please inform your doctor if you are currently taking a blood thinner. Patients should be aware that inflammation of the pancreas, blood-related complications, and reactions based on a possible sensitivity to fenofibrates may occur. Ask your doctor about these possible effects, what you should look for, and what you should do if you become aware of them. Your doctor may adjust your dosage of ANTARA® or may even discontinue its use if any of these events occur.

To avoid a drug interaction, patients should take ANTARA® at least 1 hour before or 4 to 6 hours after taking a bile acid binding resin.

Be sure to tell your doctor about all medications, supplements, and herbal preparations you are taking and report any change to your medical condition or the medicines you take.

Other Precautions and Prescribing Information

Other precautions include pancreatitis, hypersensitivity reactions, and blood changes. Please see Full Prescribing Information for a complete list of precautions.

Coumadin® (warfarin sodium) is a registered trademark of Bristol-Myers Squibb.

 

INDICATIONS

Primary Hypercholesterolemia and Mixed Dyslipidemia: ANTARA® is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Hypertriglyceridemia: ANTARA® 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. Markedly elevated levels of serum triglycerides (eg, >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.

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

IMPORTANT SAFETY INFORMATION

ANTARA® is contraindicated in patients with severe renal impairment; active liver disease, including unexplained persistent liver function abnormalities; preexisting gallbladder disease; nursing mothers; and hypersensitivity to fenofibric acid, choline fenofibrate or fenofibrate.

The effect of ANTARA® on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.

Fibrates increase the risk for myopathy and are associated with rhabdomyolysis. The risks for myopathy and rhabdomyolysis are increased when fibrates are co-administered with a statin, particularly in the elderly and in patients with diabetes, renal failure, or hypothyroidism. The combined use of fibrates and statins should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk.

Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness. Discontinue ANTARA® if myopathy/myositis is suspected or diagnosed or if CPK levels are markedly elevated.

Fenofibrate at doses equivalent to 90 mg ANTARA® per day can increase serum transaminases. Monitor liver function regularly and discontinue treatment if enzyme levels persist above 3 times the normal limit.

Fenofibrate can reversibly elevate serum creatinine. Monitor renal function in patients with renal impairment.

Fenofibrate may lead to cholelithiasis. Discontinue ANTARA® if gallstones are found.

ANTARA® can potentiate the activity of oral anticoagulants. Monitoring and dosage adjustment of anticoagulants as needed are recommended.

Other precautions include pancreatitis, hematologic changes, hypersensitivity reactions, and venothromboembolic events.

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

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