Fenofibrate

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.

Although fibrates in general (including fenofibrate) are effective at lowering levels of triglycerides, VLDL cholesterol, total cholesterol, and apolipoprotein C-III, they do not appear to reduce the risk of cardiovascular events or cardiovascular/non-cardiovascular mortality, even when used in combination with a statin.

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.

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.

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.

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, right-sided upper stomach pain, unusual tiredness, or dark urine;
• 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.

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

Skip the missed dose and take your next dose at the regular time. 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 fenofibrate will not be as effective.

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

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.