ANTARA® FAQs

What is cholesterol?

Cholesterol is a kind of lipid (fat). It is made in the liver and is also found in meat and dairy products. The amount of cholesterol in your blood has a lot to do with your chances of getting heart disease. Too much cholesterol can build up (this is called plaque) inside the walls of your arteries. Over time, arteries can become blocked and blood cannot get through to the heart. Sometimes this causes a heart attack. ANTARA® (fenofibrate capsules) 90 mg has not been shown to decrease the risk of heart attack.

What are triglycerides (TGs)?

“TGs” stands for triglycerides. Triglycerides are the most common form of fat in the body. They are stored in fat cells to be used as energy. On their own, high triglycerides can be an independent risk factor for coronary heart disease (CHD). This means that even if you have no other risk factors - being over 65, having diabetes, smoking, or being overweight - high triglycerides alone can put you at risk.

What is HDL-C?

HDL-C is the “good” cholesterol in your body, because it carries cholesterol from the blood vessels to the liver, where the body can break it down. That is why you need a high level of HDL-C. If it’s too low, it can’t carry cholesterol away.

What is LDL-C?

LDL-C is the “bad” cholesterol that can lead to the build-up of harmful plaque inside of blood vessels.

Who shouldn’t take ANTARA® capsules?

You should not take ANTARA® capsules if you are allergic or sensitive to fenofibrate, have gallbladder disease, or have liver or severe kidney disease, or if you are pregnant or nursing.

Are there other risks associated with ANTARA®?

Fenofibrate has been associated with increases of liver enzyme levels to greater than 3 times the normal limit. Liver enzymes are chemicals that are found inside of healthy liver cells. When liver enzyme levels rise, it can mean that cells are being damaged. Increased levels of liver enzymes usually returned to normal with continued treatment or by stopping treatment. However, repeated high levels of liver enzymes may harm your liver. Regular periodic monitoring of liver function should be performed and ANTARA® should be discontinued if enzyme levels remain higher than 3 times the normal limit. Fenofibrate may lead to the development of gallstones. If you feel pain in the abdominal area while taking ANTARA®, you should contact your doctor immediately. This can be a sign of gallstones or inflammation of the pancreas. If gallstones are found, ANTARA® should be discontinued. The use of fibrates including ANTARA® may occasionally be associated with muscle pain, tenderness, or weakness. Unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, could be a sign of a serious side effect and should be reported to your doctor immediately.

Will ANTARA® interfere with my other medication?

Tell your doctor if you are taking any other medicines while taking ANTARA® capsules. ANTARA® may increase the effect of anticoagulant or blood-thinning medications such as Coumadin® (warfarin sodium). Your doctor may want to monitor your anticoagulant therapy more often and may need to reduce the dose of the anticoagulant to maintain the desired level of effectiveness. The use of ANTARA® with other cholesterol-lowering drugs known as statins should be avoided unless recommended by your doctor, and the benefits are likely to outweigh the risks. The combined use of fenofibrates with statins has been associated with muscle injury and kidney damage leading to kidney failure. Because ANTARA® is eliminated through the kidneys, there is a risk that an interaction with immunosuppressant drugs such as cyclosporine could cause kidney damage. You should talk to your doctor about the benefits and risks of using ANTARA® if you are on immunosuppressant therapy or on other drugs that may be harmful to the kidneys.

What were the most frequently reported side effects during ANTARA® therapy?

In clinical trials, the most frequently observed side effects were abnormal liver function tests, respiratory disorders, abdominal pain, back pain, and headache.

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

ANTARA Full Prescribing Information.

 

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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