ANTARA FAQs

What is cholesterol?

Cholesterol is a fatty substance made by the liver. It is also supplied in the diet by foods such as egg yolk, meat, chicken, fish, and dairy products containing “saturated fats.” Saturated fats are the ones that stay solid at room temperature. They raise your blood cholesterol. Cholesterol is needed to make cell membranes and to produce certain hormones. Because the body makes enough cholesterol to do these things, it’s not necessary to have extra cholesterol in your diet.

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) 130 mg has not been shown to decrease the risk of heart attack.

What are triglycerides (TGs)?

“TG” stands for triglyceride. 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.

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. These levels usually returned to normal with continued treatment or upon discontinuation of 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.

| | | | |

Important Safety Information

ANTARA® (fenofibrate) capsules is contraindicated in patients with hypersensitivity to fenofibrate, in patients with hepatic or severe renal dysfunction including primary biliary cirrhosis, in patients with unexplained persistent liver function abnormality, and in patients with preexisting gallbladder disease.
Fenofibrate has been associated with increases in serum transaminases. Regular periodic monitoring of liver function should be performed, for duration of therapy, and therapy discontinued if enzyme levels persist above 3 times the normal limit.
There are no adequate and well-controlled studies in pregnant women. Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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, >2000 mg/dL) may increase the risk of developing pancreatitis. ANTARA therapy on reducing this risk has not been studied.
Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, ANTARA therapy should be discontinued.
The combined use of ANTARA and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk. The combined use of fibric acid derivatives and HMG-CoA reductase inhibitors has been associated with rhabdomyolysis, markedly elevated creatine kinase levels, and myoglobinuria, leading to acute renal failure.
The use of fibrates alone including ANTARA, may occasionally be associated with myositis, myopathy, or rhabdomyolysis. Patients complaining of muscle pain, tenderness, or weakness should have prompt medical evaluation for myopathy. Discontinue ANTARA if myopathy or myositis is suspected or diagnosed.
The effect of ANTARA on coronary heart disease morbidity and mortality and noncardiovascular mortality has not been established.
Patients treated with other fibrate drugs experienced an increase in noncardiovascular and cardiovascular morbidity and mortality compared with placebo-treated patients.
Other precautions include pancreatitis, hypersensitivity reactions, and hematologic changes. Refer to full Prescribing Information for a complete list of precautions.
Caution should be exercised when coumarin anticoagulants are given in conjunction with ANTARA. The dosage of the anticoagulants should be reduced to maintain the prothrombin time/INR at the desired level to prevent bleeding complications. Frequent prothrombin time/INR determinations are advisable until it has been definitely determined that the prothrombin time/INR has stabilized.
Since bile acid sequestrants may bind other drugs given concurrently, patients should take ANTARA at least 1 hour before or 4–6 hours after a bile acid binding resin to avoid impeding its absorption.
Cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine. Because renal excretion is the primary elimination route of fibrate drugs including ANTARA, there is a risk that an interaction will lead to deterioration. The benefits and risks of using ANTARA with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and lowest effective dose employed.
Fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection.
The most common (≥2% reported in clinical trials) side effects are: abnormal liver function test, including increased AST; increased ALT; CPK increase; respiratory disorder; abdominal pain; back pain; headache; diarrhea; nausea; rhinitis; asthenia; flu syndrome and constipation.

Please see full Prescribing Information.

This Web site and the information contained herein is intended for use by US residents only.