- Capsules 43 mg
- Capsules 130 mg
- Tablets 40 mg
- Tablets 120 mg
- Capsules 50 mg
- Capsules 150 mg
- Capsules 67 mg
- Capsules 134 mg
- Capsules 200 mg
- Tablets 54 mg
- Tablets 160 mg
- Tablets 48 mg
- Tablets 145 mg
- Tablets 50 mg
- Tablets 160 mg
- Capsules, delayed-release 45 mg
- Capsules, delayed-release 135 mg
Gen-Fenofibrate Micro (Canada)
Lipidil EZ (Canada)
Lipidil Supra (Canada)
PMS-Fenofibrate Micro (Canada)
Sandoz Fenofibrate S (Canada)
Decreases plasma levels of triglycerides by decreasing 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.
Well absorbed. Absolute bioavailability is approximately 81%. T max within 4 to 5 h.
Protein binding is approximately 99%. Steady state is achieved within 8 days.
Primarily conjugated with glucuronic acid. Small amount is reduced to a benzhydrol metabolite.
Primarily excreted in the urine (60%) in the form of fenofibric acid and fenofibric acid glucuronide. Approximately 25% is excreted in the feces. Elimination half-life is approximately 20 h.
Special PopulationsRenal Function Impairment
Atara , Lipofen , Lofibra , Triglide
In patients with severe renal function impairment (CrCl less than 50 mL/min), Cl of fenofibric acid is greatly reduced; minimize the dosage. In patients with moderate renal function impairment (CrCl 50 to 90 mL/min), no dosage modification is necessary.Fenoglide , Tricor , Trilipix
Half-life is prolonged in patients with mild to moderate renal function impairment (CrCl 30 to 80 mL/min). There is a 2.7-fold increase in exposure for fenofibrate and an increased accumulation of fenofibric acid during chronic dosing in patients with severe renal function impairment (CrCl less than 30 mL/min).Hepatic Function Impairment
No pharmacokinetic studies have been conducted.Elderly
Pharmacokinetic studies indicate that fenofibrate can be used in elderly subjects who have healthy renal function without accumulation of the drug or metabolites.
Indications and UsageFenofibrate
Adjunctive therapy to diet to reduce elevated LDL cholesterol, total cholesterol, triglycerides and apolipoprotein B, and to increase HDL cholesterol in patients with primary hyperlipidemia or mixed dyslipidemia (Fredrickson types IIa and IIb). Adjunctive therapy to diet for treatment of hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia).Fenofibric acid ( Trilipix )
Adjunct to diet in combination with an HMG-CoA reductase inhibitor to reduce triglycerides and increase HDL cholesterol in patients with mixed dyslipidemia and coronary heart disease or a coronary heart disease risk equivalent who are on optimal statin therapy to achieve LDL cholesterol goal; adjunctive therapy to diet to reduce triglycerides in patients with severe hypertriglyceridemia; adjunctive therapy to diet to reduce elevated LDL cholesterol, total cholesterol, triglycerides, and apolipoprotein B, and to increase HDL cholesterol in patients with primary hyperlipidemia or mixed dyslipidemia.
Hyperuricemia; hypertriglyceridemia associated with HIV lipodystrophy.
Hepatic or severe renal function impairment, including primary biliary cirrhosis; unexplained persistent liver function abnormality; preexisting gallbladder disease; hypersensitivity to fenofibrate.
Dosage and AdministrationCoadministration With an HMG-CoA Reductase Inhibitor for Treating Mixed Dyslipidemia
PO Trilipix 135 mg coadministered with an HMG-CoA reductase inhibitor.Hypertriglyceridemia
Initial dosage is 43 to 130 mg/day (max, 130 mg/day).Fenoglide tablets
Initial dosage is 40 to 120 mg/day (max, 120 mg/day).Lipofen capsules
Initial dosage is 50 to 150 mg/day (max, 150 mg/day).Lofibra capsules
67 to 200 mg/day (max, 200 mg/day).Lofibra tablets
Initial dosage is 54 to 160 mg/day (max, 160 mg/day).Tricor tablets
Initial dosage 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).Trilipix capsules
Initial dosage is 45 to 135 mg/day (max, 135 mg/day).Primary Hypercholesterolemia/Mixed Hyperlipidemia
130 mg/day.Fenofibrate tablets
Initial dosage is 160 mg/day.Fenoglide tablets
Initial dosage is 120 mg/day.Lipofen capsules
Initial dosage is 150 mg/day.Lofibra capsules
200 mg/day.Lofibra tablets
Initial dosage is 160 mg/day.Tricor tablets
Initial dosage is 145 mg/day.Triglide tablets
Initial dosage is 160 mg/day.Trilipix capsules
Initial dosage is 135 mg/day.Renal Function Impairment
Initial dosage is 43 mg/day.Fenoglide tablets
Initial dosage is 40 mg/day.Lipofen capsules
Initial dosage is 50 mg/day.Lofibra capsules
Initial dosage is 67 mg/day.Lofibra tablets
Initial dosage is 54 mg/day.Tricor tablets
Initial dosage is 48 mg/day.Triglide tablets
Initial dosage is 50 mg/day.Trilipix capsules
Initial dosage is 45 mg/day.
- 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/StabilityAntara , Fenoglide , Lipofen , Tricor , Trilipix , Triglide
Store at 59° to 86°F. Protect from light and moisture.Fenofibrate tablets, Lofibra tablets and capsules
Store at 68° to 77°F. Protect from moisture.
Drug InteractionsAnticoagulants, oral (eg, warfarin)
Anticoagulant effect may be increased.Bile acid sequestrants (eg, cholestyramine)
Reduces absorption of fenofibrate/fenofibric acid. Take fenofibrate/fenofibric acid 1 h before or 4 to 6 h after the bile acid sequestrant.Cyclosporine
Increases risk of nephrotoxicity.HMG-CoA reductase inhibitors (eg, lovastatin)
Increased risk of severe myopathy, rhabdomyolysis, and acute renal failure. Unless coprescribed (eg, fenofibric acid), avoid coadministration.
Laboratory Test Interactions
None well documented.
Headache (13%); dizziness (4%); insomnia (3%); fatigue (2%).Immediate-release
Diarrhea, dyspepsia, nausea (4%); constipation (3%).Immediate-release
Abdominal pain (5%); constipation, nausea (2%).Postmarketing
Abdominal pain, pancreatitis.
Acute renal failure, renal failure.
Increased ALT (1%).Immediate-release
Increased ALT, AST, and CPK (3%).
Back pain (6%); pain in extremities (5%); arthralgia (4%); myalgia (3%).Immediate-release
Back pain (3%).Postmarketing
Muscle spasms, rhabdomyolysis.
Upper respiratory tract infection (5%); sinusitis (3%).
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.
Category C .
Do not use in breast-feeding women.
Safety and efficacy not established.
Use with caution because decreased renal function is more likely in this age group.
Acute hypersensitivity reactions have occurred rarely, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
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.Trilipix
Avoid administration in patients with severe renal function impairment (CrCl less than 30 mL/min). Reduce the dose in patients with mild to moderate renal function impairment (CrCl 30 to 80 mL/min).
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.Trilipix
Increased serum transaminases have been reported. Discontinue therapy if enzyme levels persist above 3 × ULN.
May increase cholesterol secretion into the bile, leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Discontinue therapy if gallstones are found.
Ensure patient is on a lipid-lowering diet before starting therapy and that diet is continued during treatment.
Mild to moderate Hct, Hgb, and WBC decreases have been reported following the initiation of therapy. Rarely, thrombocytopenia and agranulocytosis have been reported.
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.
Has been reported in patients taking fenofibrate.
Secondary cause of hyperlipidemia
Rule out or treat secondary causes of hypercholesterolemia and hypertriglyceridemia before starting therapy.
Reversible elevations in serum creatinine have been reported.
Pulmonary embolism and deep vein thrombosis have been reported to occur at a higher rate in patients receiving fenofibrate compared with placebo.
Signs and symptoms have not been reported.
- 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 never to 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 patient the importance of dietary changes (eg, increase soluble fiber intake, reduce saturated fat intake, regular exercise, smoking cessation, weight control) on cholesterol control.
Copyright © 2009 Wolters Kluwer Health.
More about fenofibrate
- Fenofibrate (AHFS Monograph)
- Fenofibric Acid/Fenofibrate (AHFS Monograph)
- Fenofibrate Capsules (FDA)
- Fenofibrate Tablets (FDA)