INDICATIONS FOR LIPOFEN® (fenofibrate capsules, USP)1

  • LIPOFEN is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides (TG), and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia
  • Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological intervention alone has been inadequate
  • LIPOFEN is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia

IMPORTANT LIMITATIONS OF USE

Fenofibrate at a dose equivalent to 150 mg of LIPOFEN was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus

IMPORTANT SAFETY INFORMATION FOR LIPOFEN® (fenofibrate capsules, USP)1

LIPOFEN should not be taken by anyone who:

  • has severe kidney disease
  • has active liver disease, including cirrhosis, or gallbladder disease
  • is hypersensitive or allergic to fenofibrate or fenofibric acid
  • is a nursing mother

When talking to your healthcare providers:

  • Give them a full medical history, be sure to discuss any liver, gall bladder, or kidney problems
  • Discuss all your other health problems including any allergies
  • Give them a list of all drugs you take
  • Include on the list prescription and over-the-counter drugs and dietary supplements
  • Make sure to tell your doctor if you take the blood thinner warfarin, and any other medication for your high cholesterol, as your doctor may want to check some of your blood tests more often

After starting LIPOFEN therapy, some people may develop other health problems, tell your doctor:

  • If you have stomach or abdominal pain, it may be a sign of gallstones or pancreas inflammation
  • If you unexpectedly develop a fever, feel unusual tiredness, or have any muscle pain, tenderness, weakness, it may indicate serious muscle problems
  • If you have any other new symptoms

Common side effects of LIPOFEN include:

  • back pain
  • headache
  • nausea
  • constipation
  • difficulties in breathing
  • rhinitis (stuffy nose)

Other Important Information about LIPOFEN

  • Inform any doctor prescribing a new medication that you are taking LIPOFEN.
  • Continue to follow your prescribed lipid-modifying diet while taking LIPOFEN.
  • Take LIPOFEN once daily at the prescribed dose, swallow each capsule whole.

Reference: 1. LIPOFEN Prescribing Information. October 2011. Kowa Pharmaceuticals America, Inc. Montgomery, AL

LIP-RA-0017R