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-Feno-Micro (Canada)
Gen-Fenofibrate Micro (Canada)
Lipidil Micro (Canada)
Lipidil Supra (Canada)
Nu-Fenofibrate (Canada)
PMS-Fenofibrate Micro (Canada)
Pharmacology
Feedback for Fenofibrate
|
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 ImpairmentWith 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
HypertriglyceridemiaAdults
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).
AdultsPO 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).
AdultsPO Antara capsules: Initial dose is 43 to 130 mg/day (max, 130 mg/day).
Primary Hypercholesterolemia/Mixed HyperlipidemiaAdults
PO Tricor tablets: Initial dose is 145 mg/day. Lofibra capsules: 200 mg/day.
AdultsPO Lofibra tablets: Initial dose is 160 mg/day. Triglide tablets: Initial dose is 160 mg/day.
AdultsPO Antara capsules: 130 mg/day.
Renal Function Impairment/ElderlyAdults
PO Lofibra tablets: Initial dose is 54 mg/day.
AdultsPO Triglide tablets: Initial dose is 50 mg/day.
AdultsPO Antara capsules: Initial dose is 43 mg/day.
AdultsPO Lofibra capsules: Initial dose is 67 mg/day.
AdultsPO 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
MonitorEvaluate 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 |
More Fenofibrate resources:
Fenofibrate - Includes detailed dosage instructions.
Hyperlipoproteinemia, Hyperlipoproteinemia Type IIa (Elevated LDL), Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL), Hyperlipoproteinemia Type IV (Elevated VLDL), Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL)














