Prescribing Information

Uses and Important Safety Information You Should Know About TRILIPIX

Uses

• TRILIPIX^® (fenofibric acid) delayed-release capsules is a prescription medicine used along with diet to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol.

• TRILIPIX is also used along with diet to lower triglycerides and increase HDL cholesterol in people who are at high risk of heart disease and are taking a statin medicine to control their LDL cholesterol.

• TRILIPIX has not been shown to prevent heart attacks or stroke more than a statin alone.

Important Safety Information

• TRILIPIX should not be taken by people with liver, gallbladder, or severe kidney disease, nursing mothers, or those allergic to any product ingredient.

• Unexplained muscle pain, tenderness, or weakness, particularly when occurring with tiredness and fever, may be a sign of a serious side effect and should be reported to your healthcare provider right away. Rarely, muscle-related problems can cause kidney damage and can be fatal. The risk of these side effects may be higher when TRILIPIX is used with a statin.

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

• Your healthcare provider should do blood tests before and during treatment with TRILIPIX to check for liver or kidney problems.

• You should contact your healthcare provider if you experience abdominal pain, nausea, or vomiting while taking TRILIPIX. These may be signs of inflammation of the gallbladder or pancreas.

• Women who are pregnant should not take statins. If you are pregnant or may become pregnant, talk with your healthcare provider about TRILIPIX.

• The most common side effects with TRILIPIX include headache, heartburn, nausea, muscle aches, and increases in muscle or liver enzymes that are measured by blood tests.

This is the most important information to know about TRILIPIX. For more information, talk with your healthcare provider.

Please see the Medication Guide and Full Prescribing Information for TRILIPIX and discuss them with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number 1‑888‑4PPA‑NOW (1-888-477-2669) for assistance.