Trilipix is a broad-spectrum lipid lowering medicine that helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

Trilipix is used to treat high cholesterol and high triglyceride levels.

Trilipix is sometimes given together with other cholesterol-lowering medications.

You should not take Trilipix if you have liver disease, gallbladder disease, severe kidney disease, or if you are breastfeeding a baby.

In rare cases, Trilipix can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Before you take this medicine, tell your doctor if you have kidney disease, diabetes, or underactive thyroid.

Trilipix is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Avoid drinking alcohol while taking fenofibric acid. It can raise triglyceride levels and may increase your risk of liver damage.

Avoid eating foods that are high in fat or cholesterol. Trilipix will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Take Trilipix exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Trilipix with or without food.

Swallow the tablet or capsule whole and do not crush, chew, dissolve, or open it.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective.

Trilipix is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypertriglyceridemia:

Capsules:
-Initial dose: 45 to 135 mg orally once a day
-Maximum dose: 135 mg once a day

Tablets:
-Initial dose: 35 to 105 mg orally per day
-Maximum dose: 105 mg once a day

Comments:
-Dosages should be individualized according to patient response and if necessary, adjusted following repeat lipid determinations at 4 to 8 week intervals.

Use: As an adjunct to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia (500 mg/dL or greater); elevated TG levels of 2000 mg/dL or higher may increase the risk of developing pancreatitis

Usual Adult Dose for Hyperlipidemia:

Capsules:
135 mg orally once a day

Tablets:
105 mg orally per day

Use: As an adjunct to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), TG, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia

Usual Adult Dose for Dyslipidemia:

Capsules:
135 mg orally once a day

Tablets:
105 mg orally per day

Use: As an adjunct to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), TG, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia

You should not take Trilipix if you are allergic to fenofibric acid or fenofibrate, or if you have:

• severe kidney disease (or if you are on dialysis);

• liver disease; or

• gallbladder disease.

Do not breastfeed while using this medicine, and for at least 5 days after your last dose.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• kidney disease;

• liver disease; or

• gallbladder problems.

Trilipix can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in older adults, or people who have kidney disease, diabetes, or poorly controlled hypothyroidism (underactive thyroid).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Trilipix is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid eating foods high in fat or cholesterol, or Trilipix will not be as effective.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Get emergency medical help if you have signs of an allergic reaction to Trilipix (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

In rare cases, Trilipix can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Also call your doctor at once if you have:

• sharp stomach pain spreading to your back or shoulder blade;

• loss of appetite, stomach pain just after eating a meal;

• jaundice (yellowing of the skin or eyes);

• fever, chills, weakness, sore throat, mouth sores, unusual bruising or bleeding;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• swelling, warmth, or redness in an arm or leg.

Common Trilipix side effects may include:

• runny nose, sneezing; or

• abnormal laboratory tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some medicines can make fenofibric acid much less effective when taken at the same time. If you take any of the following medicines, take your Trilipix dose 1 hour before or 4 to 6 hours after you take the other medicine.

• cholestyramine;

• colesevelam; or

• colestipol.

Tell your doctor about all your other medicines, especially:

• other cholesterol lowering medicines;

• colchicine;

• a blood thinner such as warfarin, Coumadin, Jantoven; or

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with fenofibric acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.