Uses and Important Safety Information you should know about LIPOFEN® (fenofibrate capsules, USP)1

Uses for LIPOFEN (fenofibrate capsules, USP)

  • LIPOFEN may be used when other measures, such as diet and exercise, have not worked.
  • LIPOFEN is used, with diet, to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol in people with abnormal cholesterol levels.
  • LIPOFEN is also used with diet to lower severely high triglycerides. Improving blood sugar control in certain diabetics may prevent the need for anti-lipid drug therapy.
  • Fenofibrate has not been shown to lower a diabetic’s risk of heart disease morbidity and mortality.

Important Safety Information for LIPOFEN

  • LIPOFEN should NOT be taken by people who have active liver disease, including cirrhosis or gallbladder disease, severe kidney disease, sensitivity to any product ingredient, or by nursing mothers.
  • LIPOFEN may cause serious muscle problems. Unexplained muscle pain, tenderness, or weakness may be a sign of this type of problem and should be reported to your healthcare provider right away. Rarely, muscle-related problems can cause kidney damage and may be fatal. The risk of these side effects may be higher when LIPOFEN is used with a statin.
  • Some people require blood tests to check for liver, kidney, or other problems while taking LIPOFEN. Blood tests are needed before and during treatment with LIPOFEN to check for potential problems.
  • LIPOFEN may cause swelling of the gallbladder or pancreas. Tell your doctor at once if you experience abdominal pain, nausea, or vomiting.
  • It is not known if LIPOFEN will harm an unborn baby. Patients who are pregnant or may become pregnant should talk with a healthcare provider before starting to take LIPOFEN.
  • Common side effects include back pain, headache, nausea, constipation, difficulties in breathing and rhinitis (stuffy nose).

Other information you should know about LIPOFEN

  • Tell your healthcare provider about all the medicines you take.
  • 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.

For more information, talk with your healthcare provider.
You can see the full Prescribing Information at www.LipofenRx.com.

Reference: 1. Lipofen package insert V-1/2013 Kowa Pharmaceuticals America, Inc. Montgomery, AL.

LIP-RA-0023