Fenofibrate is a medicine used with a cholesterol reducing diet to lower high cholesterol and high triglyceride (fatty acid) levels in the blood.  It works by increasing the breaking down and removal of triglycerides from the blood. The effect of fenofibrate on cardiovascular disease progression and symptoms, and both non-cardiovascular and cardiovascular deaths has not yet been established.

You should not take fenofibrate if you have liver disease, gallbladder disease, severe kidney disease, or if you are breast-feeding a baby.

Fenofibrate can cause the breakdown of muscle tissue, which can lead 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 urine.

Take fenofibrate 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.

Some brands of fenofibrate should be taken with meals to help your body better absorb the medicine. Other brands may be taken with or without food. Follow the directions on your medicine label.

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.

Fenofibrate 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, heat, and light.

Usual Adult Dose of Fenofibrate for Hyperlipoproteinemia Type IIa (Elevated LDL):

Tricor: 145 mg orally once a day.
Lofibra and others: 160 mg to 200 mg orally once a day with food.
Antara: 130 mg orally once a day.
Triglide: 160 mg orally once a day.
Lipofen: 150 mg orally once a day with food.
Fenoglide: 120 mg orally once a day with food.

Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL):

Tricor: 145 mg orally once a day.
Lofibra and others: 160 mg to 200 mg orally once a day with food.
Antara: 130 mg orally once a day.
Triglide: 160 mg orally once a day.
Lipofen: 150 mg orally once a day with food.
Fenoglide: 120 mg orally once a day with food.

Usual Adult Dose of Fenofibrate for Hyperlipoproteinemia Type IV (Elevated VLDL):

Tricor: 48 to 145 mg orally once a day.
Lofibra and others: 54 mg to 200 mg orally once a day with food.
Antara: 43 mg to 130 mg orally once a day.
Triglide: 50 mg to 160 mg orally once a day.
Lipofen: 50 mg to 150 mg orally once a day with food.
Fenoglide: 40 mg to 120 mg orally once a day with food.

Usual Adult Dose for Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL):

Tricor: 48 to 145 mg orally once a day.
Lofibra and others: 54 mg to 200 mg orally once a day with food.
Antara: 43 mg to 130 mg orally once a day.
Triglide: 50 mg to 160 mg orally once a day.
Lipofen: 50 mg to 150 mg orally once a day with food.
Fenoglide: 40 mg to 120 mg orally once a day with food.

Usual Geriatric Dose of Fenofibrate for Hyperlipoproteinemia:

Tricor: 48 mg orally once a day. Increases in dosage should occur only after evaluating the effects on renal function and lipid levels at this dose, with a maximum recommended dose of 145 mg/24 hours.

Lofibra and others: 54 mg to 67 mg orally once a day with food. Individualize dosage according to patient response and adjust if necessary following repeat lipid determinations at 4 to 8 week intervals.

Antara: 43 mg orally once a day. Individualize dosage according to patient response and adjust if necessary following repeat lipid determinations at 4 to 8 week intervals.

Triglide: 50 mg orally once a day. Individualize dosage according to patient response and adjust if necessary following repeat lipid determinations at 4 to 8 week intervals.

Lipofen: 50 mg orally once a day with food. Individualize dosage according to patient response and adjust if necessary following repeat lipid determinations at 4 to 8 week intervals.

Fenoglide: 40 mg to 120 mg orally once a day with food

You should not take fenofibrate if you are allergic to it, or if you have:

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

• liver disease; or

• gallbladder disease.

Do not breast-feed 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.

Fenofibrate can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, 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.

Fenofibrate 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Avoid eating foods high in fat or cholesterol, or fenofibrate 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 fenofibrate (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, fenofibrate 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 fenofibrate 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 fenofibrate much less effective when taken at the same time. If you take any of the following medicines, take your 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 affect fenofibrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain laboratory tests to check your response to fenofibrate.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.