A-Z Drug Facts > Fenofibrate

Fenofibrate

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

Trade Names:
Antara
- Capsules 43 mg
- Capsules 130 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)
Gen-Fenofibrate Micro (Canada)
Lipidil Micro (Canada)
Lipidil Supra (Canada)
Nu-Fenofibrate (Canada)
PMS-Fenofibrate Micro (Canada)

Pharmacology

Feedback for Fenofibrate As a treatment for... Avg User Ratings [?] Hyperlipoproteinemia 8.0 0 comments  Rate it! Hyperlipoproteinemia Type IIa (Elevated LDL) Be the first to rate it 0 comments   Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL) Be the first to rate it 0 comments   Showing 3 of 5 conditions - Show All... Compare with other drugs.

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 of micronized fenofibrate increased with food. T _max is 6 to 8 h.

Distribution

About 99% bound to plasma proteins; Vd is about 30 L. Steady state is achieved within 5 days of dosing.

Metabolism

Hydrolyzed by esterases to the active metabolite of 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 and Cl is 1.1 L/h.

Special Populations

Renal Function Impairment

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

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

Treatment of hyperuricemia.

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

PO Tricor tablets: Initial dose is 48 to 145 mg/day (max, 145 mg/day). Lofibra capsules: 67 to 200 mg/day (max, 200 mg/day).

Adults

PO Lofibra tablets: Initial dose is 54 to 160 mg/day (max, 160 mg/day). Triglide tablets: Initial dose is 50 to 160 mg once daily (max, 160 mg/day).

Adults

PO Antara capsules: Initial dose is 43 to 130 mg/day (max, 130 mg/day).

Primary Hypercholesterolemia/Mixed Hyperlipidemia
Adults

PO Tricor tablets: Initial dose is 145 mg/day. Lofibra capsules: 200 mg/day.

Adults

PO Lofibra tablets: Initial dose is 160 mg/day. Triglide tablets: Initial dose is 160 mg/day.

Adults

PO Antara capsules: 130 mg/day.

Renal Function Impairment/Elderly
Adults

PO Lofibra tablets: Initial dose is 54 mg/day.

Adults

PO Triglide tablets: Initial dose is 50 mg/day.

Adults

PO Antara capsules: Initial dose is 43 mg/day.

Adults

PO Lofibra capsules: Initial dose is 67 mg/day.

Adults

PO Tricor tablets: Initial dose is 48 mg/day.

General Advice

• Use alone or in combination with other lipid-lowering therapy.
• Administer prescribed dose with food to increase absorption with Lofibra and Antara . Triglide 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 at controlled room temperature (68° to 77°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 (eg, Sandimmune )

Increases risk of nephrotoxicity.

HMG-CoA reductase inhibitors (eg, lovastatin)

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

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Arrhythmia, atrial fibrillation, extrasystoles.

CNS

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

GI

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

Hematologic-Lymphatic

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

Hypersensitivity

Rash, urticaria (1%); Stevens-Johnson syndrome, toxic epidermal necrolysis.

Lab Tests

Abnormal LFTs (8%); increased ALT, AST, CPK (3%).

Musculoskeletal

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

Respiratory

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

Miscellaneous

Flu syndrome (2%).

Precautions

Monitor 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 to detect rare episodes of thrombocytopenia and granulocytopenia.

Pregnancy

Category C .

Lactation

Do not use in breast-feeding women. Discontinue drug or breast-feeding.

Children

Safety and efficacy not established.

Renal Function

When Ccr 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. Perform regular periodic monitoring of liver function for duration of therapy; 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.

Myopathy/Myositis

Can be associated with use of fibrates alone or in combination with HMG-CoA reductase inhibitors. 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.

Patient Information

• Advise patient to take each dose with food to increase absorption ( Lofibra and Antara ) 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.
• Caution patient not to change the dose or stop taking fenofibrate unless advised by health care provider.
• 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 importance of dietary changes (eg, increase soluble fiber intake, reduce saturated fat intake, regular exercise, smoking cessation, weight control) on cholesterol control.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breast-feeding.

Link to this page

Printable Version

Email Page

Add to my drug list