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Fenofibrate

Pronouncation: (FEN-oh-FYE-brate)
Class: Antihyperlipidemic

Trade Names:
Antara
- Capsules 43 mg
- Capsules 130 mg

Trade Names:
Lipofen
- Capsules 50 mg
- Capsules 150 mg

Trade Names:
Lofibra
- Capsules 67 mg
- Capsules 134 mg
- Capsules 200 mg
- Tablets 54 mg
- Tablets 160 mg

Trade Names:
Tricor
- Tablets 48 mg
- Tablets 145 mg

Trade Names:
Triglide
- Tablets 50 mg
- Tablets 160 mg

Apo-Fenofibrate (Canada)
Apo-Feno-Micro (Canada)
Apo-Feno-Super (Canada)
Fenomax (Canada)
Gen-Fenofibrate Micro (Canada)
Lipidil EZ (Canada)
Lipidil Supra (Canada)
PMS-Fenofibrate Micro (Canada)
Sandoz Fenofibrate S (Canada)

Pharmacology

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Mechanism not well established. Apparently decreases plasma levels of triglycerides by decreasing their synthesis. Also reduces plasma levels of VLDL cholesterol by reducing its release into the circulation and increasing catabolism. Reduces serum uric acid levels by increasing urinary excretion of uric acid.

Pharmacokinetics

Absorption

Well absorbed; absorption is increased with food. T _max is 6 to 8 h.

Distribution

About 99% bound to plasma proteins. Steady state is achieved within 5 days of dosing.

Metabolism

Hydrolyzed by esterases to the active metabolite fenofibric acid. Fenofibric acid is conjugated with glucuronic acid and then excreted.

Elimination

Excretion is 60% in the urine in the form of metabolites; 25% excreted in the feces. The t _½ is 20 h.

Special Populations

Renal Function Impairment

With severe renal function impairment (CrCl less than 50 mL/min), rate of Cl is greatly reduced. Minimize dosage.

Hepatic Function Impairment

No pharmacokinetic studies have been conducted.

Indications and Usage

Adjunctive therapy to diet for treatment of hypertriglyceridemia in adult patients with type 4 or 5 hyperlipidemia; adjunctive therapy to diet for the reduction of LDL cholesterol, total cholesterol, triglycerides, and apolipoprotein B, and to increase HDL cholesterol in adults with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb).

Unlabeled Uses

Hyperuricemia; hypertriglyceridemia associated with HIV lipodystrophy.

Contraindications

Hepatic or severe renal function impairment, including primary biliary cirrhosis; unexplained persistent liver function abnormality; preexisting gallbladder disease; hypersensitivity to fenofibrate.

Dosage and Administration

Hypertriglyceridemia
Adults

Antara capsules

Initial dose is 43 to 130 mg/day (max, 130 mg/day).

Lipofen capsules

Initial dose is 50 to 150 mg/day (max, 150 mg/day).

Lofibra capsules

67 to 200 mg/day (max, 200 mg/day).

Lofibra tablets

Initial dose is 54 to 160 mg/day (max, 160 mg/day).

Tricor tablets

Initial dose is 48 to 145 mg/day (max, 145 mg/day).

Triglide tablets

Initial dosage is 50 to 160 mg once daily (max, 160 mg/day).

Primary Hypercholesterolemia/Mixed Hyperlipidemia
Adults

Antara capsules

130 mg/day.

Lipofen capsules

Initial dose is 150 mg/day.

Lofibra capsules

200 mg/day.

Lofibra tablets

Initial dose is 160 mg/day.

Tricor tablets

Initial dose is 145 mg/day.

Triglide tablets

Initial dose is 160 mg/day.

Renal Function Impairment/Elderly
Adults

Antara capsules

Initial dose is 43 mg/day.

Lipofen capsules

Initial dose is 50 mg/day.

Lofibra capsules

Initial dose is 67 mg/day.

Lofibra tablets

Initial dose is 54 mg/day.

Tricor tablets

Initial dose is 48 mg/day.

Triglide tablets

Initial dose is 50 mg/day.

General Advice

Use alone or in combination with other lipid-lowering therapy.
Administer prescribed dose with food to increase absorption with Lofibra . Triglide and Tricor may be given without regard to meals.
Administer prescribed dose 1 h before or 4 to 6 h after a bile acid sequestrant (eg, cholestyramine).

Storage/Stability

Store Lofibra and Triglide at controlled room temperature (68° to 77°F). Store Antara , Lipofen , and Tricor at 59° to 86°F. Protect from light and moisture.

Drug Interactions

Anticoagulants, oral (eg, warfarin)

Anticoagulant effect may be increased.

Bile acid sequestrants (eg, cholestyramine)

Reduces absorption of fenofibrate.

Cyclosporine

Increases risk of nephrotoxicity.

HMG-CoA reductase inhibitors (eg, lovastatin)

Increased risk of severe myopathy, rhabdomyolysis, and acute renal failure. Avoid coadministration.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache (3%); asthenia (2%).

Dermatologic

Stevens-Johnson syndrome, toxic epidermal necrolysis.

GI

Abdominal pain (5%); constipation, diarrhea, nausea (2%).

Hematologic-Lymphatic

Agranulocytosis; mild to moderate Hct, Hgb, and WBC decreases; thrombocytopenia.

Hypersensitivity

Rash, urticaria (1%).

Lab Tests

Abnormal LFTs (8%); increased ALT, AST, CPK (3%); increased plasma creatine urea; decreased plasma alkaline phosphatase.

Musculoskeletal

Back pain (3%); myalgia, myositis, rhabdomyolysis.

Respiratory

Respiratory disorder (6%); rhinitis (2%).

Miscellaneous

Flu syndrome (2%); hepatitis.

Precautions

Monitor

Perform regular periodic monitoring of liver function for duration of therapy. Evaluate serum lipids periodically (eg, 4 to 8 wk) during initial therapy to determine lowest effective dose; withdraw therapy if an adequate response is not achieved after 2 mo of treatment with the max dose. Perform periodic blood cell counts during first 12 mo of therapy.

Pregnancy

Category C .

Lactation

Do not use in breast-feeding women.

Children

Safety and efficacy not established.

Elderly

Use with caution because decreased renal function is more likely in this age group.

Hypersensitivity

Acute hypersensitivity reactions have occurred rarely, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Renal Function

When CrCl is less than 50 mL/min, initiate therapy at lowest dose and increase only after evaluation of the effects on renal function and triglyceride levels at this dose.

Hepatic Function

Drug may cause significant increases in serum transaminases. If elevated serum levels develop during treatment, repeat levels more frequently. Discontinue therapy if enzyme levels persist at more than 3 times the normal limit.

Cholelithiasis

May increase cholesterol secretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Discontinue therapy if gallstones are found.

Diet

Ensure patient is on a lipid-lowering diet before starting therapy and that diet is continued during treatment.

Hematology

Mild to moderate Hct, Hgb, and WBC decreases have been reported following the initiation of therapy. Rarely, thrombocytopenia and agranulocytosis have been reported.

Hypersensitivity reactions

Acute hypersensitivity reactions, including severe skin rashes (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) requiring hospitalization and treatment, have been reported.

Myopathy/Myositis

Can be associated with use of fibrates alone, usually in patients with renal function impairment. Consider in any patient with diffuse myalgia, muscle tenderness or weakness, or marked CPK elevations. Discontinue therapy if myopathy/myositis is suspected or diagnosed.

Pancreatitis

Has been reported in patients taking fenofibrate.

Secondary cause of hyperlipidemia

Rule out or treat secondary causes of hypercholesterolemia and hypertriglyceridemia before starting therapy.

Overdosage

Symptoms

Signs and symptoms have not been reported.

Patient Information

Advise patient to take each dose of Lofibra with food to increase absorption and lipid-lowering effectiveness.
Advise patient who also is taking a bile acid resin (eg, cholestyramine) to take fenofibrate 1 h before or 4 to 6 h after the resin.
Advise patient to try to take each dose at about the same time each day.
Inform patient that drug helps control, but not does cure, lipid abnormality and to continue taking drug as prescribed if lipid levels are lowered.
Advise patient that if a dose is missed to take it as soon as possible, but to never take more than 1 dose of fenofibrate a day.
Instruct patient to continue taking other cholesterol-lowering medications as prescribed by health care provider.
Emphasize to the patient the importance of dietary changes (eg, increase soluble fiber intake, reduce saturated fat intake, regular exercise, smoking cessation, weight control) on cholesterol control.