Information for Healthcare Professionals

Other Conditions

People with elevated cholesterol and certain health conditions – such as diabetes and heart disease – need to be especially careful about their cholesterol levels.

People with diabetes are considered to be at high risk because they are 2 to 4 times more likely to develop heart disease than people who don’t have diabetes. People with diabetes who already have heart disease should try to achieve a very low LDL-C level (less than 70 mg/dL). Doctors may recommend that they take cholesterol-lowering medications even if their current LDL-C levels are normal.¹

People with diabetes who do not have heart disease also should strive for a low LDL-C level. However, whether doctors will prescribe a cholesterol-lowering drug or not will depend on the presence of other risk factors. Current medical guidelines suggest taking cholesterol-lowering medication if your LDL-C is more than 130 mg/dL.

The amount of cholesterol in your blood has a lot to do with your chances of developing heart disease. Too much LDL cholesterol can build up (as 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. The higher your LDL-C number, the greater your chances for coronary heart disease (CHD).

Talk to Your Doctor

If you have one of these conditions, it is very important to monitor your cholesterol. Read more on how you can lower your cholesterol and talk with your doctor about whether ANTARA® (fenofibrate capsules) 130 mg may be right for you.

1. Grundy SM, Cleeman JI, Merz CN, Brewer B, Clark LT, Hunninghake DB et al. Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004;110:227-239.

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.

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