Lipid Control with Choices. LOFIBRA® Fenofibrate Tablets and Capsules (Micronized)

Risk Factors®

Certain conditions or habits can increase your risk of developing too much bad cholesterol and triglycerides, but not enough good cholesterol. Ultimately these risk factors lead to heart disease and serious medical problems.

  • Previous heart disease or stroke
  • Diabetes
  • High blood pressure
  • Age (Men 45; Women 55)
  • Family history of early heart disease in an immediate relative (Men <55 years; Women <65 years)
  • Low HDL-C (<40 mg/dL)
  • Cigarette smoking
  • Obesity and excess weight
  • Lack of physical activity
  • Too much alcohol
  • Certain diseases, such as kidney failure
  • Certain drugs, including steroids, estrogens, and high doses of beta-blockers

There are certain risk factors that you have no control over, such as your age, sex, race, or family history. Therefore, it's even more important to treat and control the other risk factors that you can impact.

Reference

2. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001;285(19):2486-2497.

Indication

LOFIBRA® (fenofibrate capsules [micronized] and fenofibrate tablets) is a prescription medicine that, along with diet, reduces “bad” cholesterol (LDL) and triglycerides and increases “good” cholesterol (HDL) in your blood. While taking LOFIBRA®, a diet low in saturated fat and cholesterol should be followed. The long term effect of LOFIBRA® on cardiovascular events and mortality has not been determined.

Important Safety Information

The use of LOFIBRA® should be considered only when non-drug methods, such as diet, exercise, and weight loss, have failed to obtain satisfactory results.

Tell your doctor about all the medications you are taking. Some medications are known to cause an increase in triglycerides in the blood.

You should not take LOFIBRA® if you have severe kidney disease, have liver or gallbladder disease, are nursing, or are allergic to LOFIBRA®.

LOFIBRA® can cause liver or gallbladder problems. Your doctor may do blood tests to monitor your liver function or studies to check for gallstones.

Tell your doctor if you are taking any medications to slow the clotting of your blood (anticoagulants or blood thinners). LOFIBRA® may increase the effect of these medications, so your doctor may do frequent blood tests and may need to adjust your dose.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness as these can be signs of a rare, but serious, side effect.

The most common side effects of LOFIBRA® are abdominal pain, abnormal liver tests, and respiratory symptoms.

Please see accompanying full prescribing information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 800.FDA.1088.