Fenofibrate

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in clinical practice.

Adverse events reported by 2% or more of patients treated with fenofibrate and greater than placebo during double-blind, placebo-controlled trials, regardless of causality, are listed in Table 1. Adverse reactions led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

Table 1 : Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

Postmarketing Experience

The following adverse reactions have been identified during post approval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, arthralgia, asthenia and severely depressed HDL-cholesterol levels. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

The brand Tricor is available in strengths of 54 milligrams (mg) and 160 mg. Generic fenofibrate is available in 48 mg and 154 mg tablets. You should not take more than the highest dose prescribed by your doctor in one day.

Always take fenofibrate with a full glass of water regardless of whether you eat. Eating may delay fenofibrate’s effect.

Fenofibrate Overdose

If you suspect an overdose, you should contact a poison-control center or emergency room immediately. You can contact a poison-control center at (800) 222-1222.

Missed Dose of Fenofibrate

If you miss a dose of fenofibrate, try to take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of the medication at the same time.

Primary Hypercholesterolemia or Mixed Dyslipidemia

LIPOFEN is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

Severe Hypertriglyceridemia

LIPOFEN is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.

Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

Important Limitations of Use

Fenofibrate at a dose equivalent to 150 mg of LIPOFEN was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see WARNINGS AND PRECAUTIONS].

Fenofibrate is a prescription medication used to lower cholesterol and triglycerides (a type of fat) and to increase HDL ("good") cholesterol in the blood. It may be used alone or with other cholesterol-lowering medications. Fenofibrate belongs to a group of drugs called fibrates. These work by increasing the activity of an enzyme involved in removing triglycerides and cholesterols from the body.

This medication comes in capsule and tablet form and is taken once a day, with or without food.

Common side effects of fenofibrate include headaches, heartburn, nausea, and muscle aches.

Fenofibrate may be found in some form under the following brand names:

• Antara

• Fenoglide

• Fibricor

• Lipidil Supra

• Lipofen

• Lofibra

• Tricor

• Triglide

Fenofibrate is part of the drug class:

• Fibrates

Serious side effects have been reported with fenofibrate. See the "Fenofibrate Precautions" section.

Common side effects of fenofibrate include:

• constipation
• diarrhea
• heartburn
• pain in the back, arm, or legs

This is not a complete list of fenofibrate side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking fenofibrate, tell your healthcare provider about all your medical conditions. Especially tell your doctor if you:

• are allergic to fenofibrate or to any of its ingredients
• have ever had kidney disease
• have ever had liver disease
• have ever had gallbladder disease
• are pregnant or breastfeeding

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rate observed in clinical practice.

Adverse reactions reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials, regardless of causality, are listed in Table 1 below. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

Table 1: Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fenofibrate: myalgia, rhabdomyolysis, pancreatitis, acute renal failure, muscle spasm, hepatitis, cirrhosis, anemia, arthralgia, decreases in hemoglobin, decreases in hematocrit, white blood cell decreases, asthenia, and severely depressed HDL cholesterol levels. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Fenofibrate (Fenofibrate)

You should not use fenofibrate if you are allergic to it, or if you have liver disease, gallbladder disease, severe kidney disease, or if you are on dialysis.

Do not take fenofibrate if you are breast-feeding a baby.

Before you take fenofibrate, tell your doctor if you have kidney disease, diabetes, heart disease, a thyroid disorder, or a history of pancreatitis or liver disease.

Avoid drinking alcohol. It can raise triglyceride levels, and may also damage your liver while you are taking fenofibrate.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Fenofibrate 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).

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

Fenofibrate may also be used for purposes not listed in this medication guide.

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

• liver disease;
• severe kidney disease (or if you are on dialysis);
• gallbladder disease;
• if you are breast-feeding a baby.

To make sure fenofibrate is safe for you, tell your doctor if you have:

• kidney disease;
• diabetes;
• heart disease;
• a thyroid disorder; or
• a history of pancreatitis or liver disease.

FDA pregnancy category C. It is not known whether fenofibrate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Fenofibrate can pass into breast milk and may harm a nursing baby. Do not breast-feed while taking fenofibrate.

If you also take cholestyramine, colesevelam, or colestipol: Wait 4 to 6 hours after taking any of these other medicines before you take fenofibrate. Avoid taking fenofibrate within 1 hour before taking the other medicine.

Avoid drinking alcohol. It can raise triglyceride levels, and may also damage your liver while you are taking fenofibrate.

Fenofibrate 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).

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

Fenofibrate may also be used for purposes not listed in this medication guide.

You should not use fenofibrate if you are allergic to it, or if you have liver disease, gallbladder disease, severe kidney disease, or if you are on dialysis.

Do not take fenofibrate if you are breast-feeding a baby.

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

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

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

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

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

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

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

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

Usual Geriatric Dose of Fenofibrate for Hyperlipoproteinemia:

Tricor (R): 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 (R) 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 (R): 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 (R): 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 (R): 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 (R): 40 mg to 120 mg orally once a day with food

Commonly reported side effects of fenofibrate include: increased serum aspartate aminotransferase and increased serum alanine aminotransferase. Other side effects include: abnormal hepatic function tests, increased creatine phosphokinase, and increased serum transaminases. See below for a comprehensive list of adverse effects.

Capsules:
-Initial dose: 50 to 150 mg orally per day
-Maximum dose: 150 mg once a day

Micronized Capsules:
-Initial dose: 30 to 200 mg orally per day
-Maximum dose: 90 to 200 mg/day

Tablets:
-Initial dose: 40 to 160 mg orally per day
-Maximum dose: 120 to 160 mg/day

Comments:
-Dosages should be individualized according to patient response and adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.
-Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose.

Use: As an adjunct to diet for the treatment of severe hypertriglyceridemia (Fredrickson Types IV and V)

• Fenofibrate is effective at reducing triglyceride levels and increasing HDL cholesterol levels; however, it is less effective than statins at reducing LDL cholesterol levels.

• Can be given with or without food.
• Use in addition to an appropriate lipid-lowering diet and regular exercise. Reducing body weight and alcohol consumption will also help lower cholesterol and triglyceride levels.
• Report promptly any unexplained muscle tenderness, weakness or pain, especially if other symptoms (such as fever or feeling unwell) are also present.
• Seek urgent medical attention if you develop symptoms of an allergic reaction (such as difficulty breathing, swelling, or a rash) or yellowing of the skin or eyes while taking fenofibrate.
• Diseases such as hypothyroidism (low thyroid levels) and diabetes contribute to dyslipidemia, so it is important these are treated as well. In addition, some medications (for example, estrogen, bendroflumethiazide, and atenolol) may increase triglyceride levels.
• Monitoring of cholesterol/triglyceride levels every four to eight weeks is important to establish the effectiveness of fenofibrate therapy. Your doctor should consider discontinuing therapy if you have not had an adequate response after two months of treatment.