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Special Alerts:

TriCor® Formulation Change - November, 2004

A new formulation of TriCor® tablets is now available. The new tablets are available in 48 mg and 145 mg strengths, and may be taken with or without food. The old formulation will no longer be available.

Additional information is available at http://www.tricortablets.com, last accessed December 1, 2004.

Pronunciation:

(fen oh FYE brate)

U.S. Brand Names:

Antara™; Lofibra™; TriCor®

Synonyms:

Procetofene; Proctofene

Generic Available:

Canadian Brand Names:

Apo-Fenofibrate®; Apo-Feno-Micro®; Gen-Fenofibrate Micro; Lipidil Micro®; Lipidil Supra®; Novo-Fenofibrate; Nu-Fenofibrate; PMS-Fenofibrate Micro; TriCor®

Use:

Adjunct to dietary therapy for the treatment of adults with very high elevations of serum triglyceride levels (types IV and V hyperlipidemia) who are at risk of pancreatitis and who do not respond adequately to a determined dietary effort; adjunct to dietary therapy for the reduction of low density lipoprotein cholesterol (LDL-C), total cholesterol (total-C), triglycerides, and apolipoprotein B (apo B) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson types IIa and IIb)

Pregnancy Risk Factor:

Pregnancy Implications:

Animal studies have shown embryocidal and teratogenic effect. There are no adequate and well-controlled studies in pregnant women. Use should be avoided, if possible, in pregnant women since the neonatal glucuronide conjugation pathways are immature.

Lactation:

Excretion in breast milk unknown/not recommended

Contraindications:

Hypersensitivity to fenofibrate or any component of the formulation; hepatic or severe renal dysfunction including primary biliary cirrhosis and unexplained persistent liver function abnormalities; pre-existing gallbladder disease

Warnings/Precautions:

Hepatic transaminases can become significantly elevated (dose-related). Regular monitoring of liver function tests is required. May cause cholelithiasis. Use caution with warfarin; adjustments in warfarin therapy may be required. Use caution with HMG-CoA reductase inhibitors (may lead to myopathy, rhabdomyolysis). The effect of CAD morbidity and mortality has not been established. Therapy should be withdrawn if an adequate response is not obtained after 2 months of therapy at the maximal daily dose. Rare hypersensitivity reactions may occur. Dose adjustment is required for renal impairment and elderly patients. Safety and efficacy in children have not been established.

Adverse Reactions:

1% to 10%:

Gastrointestinal: Abdominal pain (5%), constipation (2%)

Hepatic: ALT increased (3%), AST increased (3%), creatine phosphokinase increased (3%), liver function tests abnormal (7%)

Neuromuscular & skeletal: Back pain (3%)

Respiratory: Respiratory disorder (6%), rhinitis (2%)

Frequency not defined:

Cardiovascular: Angina pectoris, arrhythmia, atrial fibrillation, cardiovascular disorder, chest pain, coronary artery disorder, edema, electrocardiogram abnormality, extrasystoles, hyper-/hypotension, migraine, MI, palpitation, peripheral edema, peripheral vascular disorder, phlebitis, tachycardia, varicose veins, vasodilatation

Central nervous system: Anxiety, depression, dizziness, fever, insomnia, malaise, nervousness, neuralgia, pain, somnolence, vertigo

Dermatologic: Acne, alopecia, bruising, contact dermatitis, eczema, fungal dermatitis, maculopapular rash, nail disorder, photosensitivity reaction, pruritus, skin ulcer, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Endocrine & metabolic: Diabetes mellitus, gout, gynecomastia, hypoglycemia, hyperuricemia

Gastrointestinal: Anorexia, appetite increased, colitis, diarrhea, dry mouth, duodenal ulcer, dyspepsia, eructation, esophagitis, flatulence, gastroenteritis, gastritis, gastrointestinal disorder, nausea, peptic ulcer, rectal disorder, rectal hemorrhage, tooth disorder, vomiting, weight gain/loss

Genitourinary: Cystitis, dysuria, prostatic disorder, libido decreased, pregnancy (unintended), urinary frequency, urolithiasis, vaginal moniliasis

Hematologic: Agranulocytosis, anemia, eosinophilia, leukopenia, lymphadenopathy, thrombocytopenia

Hepatic: Cholelithiasis, cholecystitis, fatty liver deposits

Neuromuscular & skeletal: Arthralgia, arthritis, arthrosis, bursitis, hypertonia, joint disorder, leg cramps, muscle pain, myalgia, myasthenia, myopathy, myositis, paresthesia, rhabdomyolysis, tenderness, tenosynovitis, weakness

Ocular: Abnormal vision, amblyopia, cataract, conjunctivitis, eye disorder, refraction disorder

Otic: Ear pain, otitis media

Renal: Creatinine increased, kidney function abnormality

Respiratory: Asthma, bronchitis, cough increased, dyspnea, laryngitis, pharyngitis, pneumonia, sinusitis

Miscellaneous: Allergic reaction, cyst, diaphoresis, herpes simplex, herpes zoster, hypersensitivity reaction, infection

Overdosage/Toxicology:

Symptoms of overdose include nausea, vomiting, diarrhea, and GI distress. Treatment is supportive. Hemodialysis has no effect on removal of fenofibric acid from the plasma.

Drug Interactions:

Substrate of CYP3A4 (minor); Inhibits (weak) CYP1A6, 2C9, 2C19

Bile acid sequestrants: May decrease absorption of fenofibrate; administer fenofibrate at least 1 hour before or 4-6 hours after a bile acid binding resin.

Ezetimibe: Fibric acid derivatives may increase serum concentrations of ezetimibe.

HMG-CoA reductase inhibitors (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin): May increase the risk of myopathy and rhabdomyolysis. The manufacturer warns against concomitant use. However, combination therapy with statins has been used in some patients with resistant hyperlipidemias (with great caution).

Sulfonylureas: Fibric acid derivatives may enhance the hypoglycemic effects of sulfonylureas.

Warfarin: Increased hypoprothrombinemic response; monitor INRs closely when fenofibrate is initiated or discontinued.

Mechanism of Action:

Fenofibric acid is believed to increase VLDL catabolism by enhancing the synthesis of lipoprotein lipase; as a result of a decrease in VLDL levels, total plasma triglycerides are reduced by 30% to 60%; modest increase in HDL occurs in some hypertriglyceridemic patients

Pharmacodynamics/Kinetics:

Absorption: Increased when taken with meals

Distribution: Widely to most tissues

Protein binding: >99%

Metabolism: Tissue and plasma via esterases to active form, fenofibric acid; undergoes inactivation by glucuronidation hepatically or renally

Half-life elimination: 20-23 hours

Time to peak: 4-8 hours

Excretion: Urine (60% as metabolites); feces (25%); hemodialysis has no effect on removal of fenofibric acid from plasma

Dosage:

Oral:

Adults:

Hypertriglyceridemia: Initial:

Antara™: 43-130 mg/day

Lofibra™: 67 mg/day with meals, up to 200 mg/day

TriCor®: 48 mg/day, up to 145 mg/day

Previously dosed as 54 mg/day with meals (up to 160 mg/day) using the old tablet formulation

Hypercholesterolemia or mixed hyperlipidemia: Early:

Antara™: 130 mg/day

Lofibra™: 200 mg/day with meals

TriCor®: 145 mg/day

Previously dosed as 160 mg/day with meals using the old tablet formulation

Elderly: Initial: 43 mg/day (Antara™) or 67 mg/day (Lofibra™) or 48 mg/day (TriCor®)

Dosage adjustment/interval in renal impairment: Use caution in dosage adjustment. Monitor renal function and lipid panel before adjusting. Decrease dose or increase dosing interval for patients with renal failure: Initial: 43 mg/day(Antara™) or 67 mg/day (Lofibra™) or 48 mg/day (TriCor®)

Hemodialysis has no effect on removal of fenofibric acid from the plasma.

Administration:

6-8 weeks of therapy is required to determine efficacy.

Capsule: Administer with meals.

Tablet: May be administered with or without food.

Monitoring Parameters:

Total cholesterol, LDL-C, triglycerides, and HDL-C should be measured periodically; If only marginal changes are noted in 6-8 weeks, the drug should be discontinued. Monitor LFTs regularly and discontinue therapy if levels >3 times normal limits.

Dietary Considerations:

Capsule should be taken with food. Tablet may be taken with or without food.

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy without consulting prescriber. Take as directed with food. Do not change dosage or dosage form or frequency without consulting prescriber. Maintain diet and exercise program as prescribed. May cause mild GI disturbances (eg, gas, diarrhea, constipation, nausea); inform prescriber if these are severe. Report immediately unusual muscle pain or weakness, skin rash or irritation, insomnia, or persistent dizziness. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.

Cardiovascular Considerations:

Fibric acids decrease triglycerides (TGs) by 20% to 50%, and increase HDL-cholesterol (HDL-C) by 10% to 35%. They decrease LDL-cholesterol (LDL-C) by 5% to 20%, however, LDL-C actually may increase by 10% to 30% when fibrates are initiated in patients with high TGs (>400 mg/dL).

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May rarely cause drowsiness or insomnia

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Capsule [micronized]

Antara™: 43 mg, 87 mg, 130 mg

Lofibra™: 67 mg, 134 mg, 200 mg

Tablet

TriCor®: 54 mg [DSC], 160 mg [DSC]

TriCor® [new formulation]: 48 mg, 145 mg

International Brand Names:

Apo-Feno® (CZ, PL); Apo-Fenofibrate® (CA); Apo-Feno-Micro® (CA); Cil® (DE); Controlip® (CR, DO, GT, HN, MX, PA, SV); durafenat® (DE); Ediafena® (CL); Evothyl® (ID); Fegenor® (FR); Fenobeta® (DE); Fenobrate® (AR); Fenobrat® (HU); Fenofanton® (DE); Fenofibrat AbZ® (DE); Fenofibrat AL® (DE); Fenofibrat AZU® (DE); Fenofibrate BMS® (CZ); Fénofibrate Debat® (FR); Fenofibrat FPh® (DE); Fenofibrat Genericon® (AT); Fenofibrat Heumann® (DE); Fenofibrat Hexal® (DE); Fenofibrat Nycomed® (AT); Fenofibrat-ratiopharm® (DE, LU); Fenofibrat® (RO); Fenofibrat Sandoz® (DE); Fenofibrat Stada® (DE); fenofibrat von ct® (DE); Fenogal® (BE, GB); Fenogal Lidose® (SG); Fenolip® (AT); Fenoratio® (PL); Fulcro® (IT); Gen-Fenofibrate Micro (CA); Grofibrat® (PL); Hipolip® (ID); Hyperchol® (ID); Hypolip® (CZ); Katalip® (SI); Lexemin® (SG, TH); Lichol® (RO); Lipanthyl® (BE, CH, CY, CZ, DE, FI, FR, HK, HU, ID, IT, KW, LB, LU, PL, PT, RO, RU, SE, SG, TH, TR); Lipantil® (GB, IE); Liparison® (ES); Lipcor® (AT); Lipicard® (IN); Lipidil® (AR, CL, DE, EC, HR, HU, MX); Lipidil Micro® (CA); Lipidil Supra® (CA); Lipidil-Ter® (DE); Lipilfen® (RO); LipIrex® (CZ); Lipivim® (RO); Lipofene® (IT); Lipofen® (TR); Lipofibrat® (PL); Lipoplasmin® (AR); Lipsin® (AT, IT, ZA); MTW-Fenofibrat® (DE); Nolipax® (IT); Normalip® (DE); Normolip® (CO); Novo-Fenofibrate (CA); Nu-Fenofibrate (CA); PMS-Fenofibrate Micro (CA); Procetoken® (AR); Protolipan® (AR); Qualecon® (AR); Scleril® (IT); Sclerofin® (AR); Secalip® (ES); Sécalip® (FR); Supralip® (GB, TH); Tilene® (IT); Trichol® (ID); TriCor® (CA); Versamid® (CY); Volutine® (IT); Yosenob® (ID); Zumafib® (ID)

References

de Lorgeril M, Salen O, Paillard F, et al, "Lipid-Lowering Drugs and Homocyst(e)ine,"Lancet, 1999, 353(9148):209-10.

"Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III),"JAMA, 2001, 285(19):2486-97.

Farnier M, Bonnefous F, Debbas N, et al, "Comparative Efficacy and Safety of Micronized Fenofibrate and Simvastatin in Patients With Primary Type IIa or IIb Hyperlipidemia,"Arch Intern Med, 1994, 154(4):441-9.

Mahley RW and Bersot TP, "Drug Therapy for Hypercholesterolemia and Dyslipidemia,"Goodman and Gilman's The Pharmacological Basis of Therapeutics, 10th ed, Hardman JE and Limbird LE, eds, New York, NY: McGraw-Hill, 2001, 993-5.

Sitori CR, Montanari G, Gianfranceschi G, et al, "Correlation Between Plasma Levels of Fenofibrate and Lipoprotein Changes in Hyperlipidaemic Patients,"Eur J Clin Pharmacol, 1985, 28(6):619-24.

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