Fenofibrate
- Atc Codes:C10AB05
- CAS Codes:49562-28-9
- PHARMGKB ID:49562-28-9
Table of contents
- Brand Names
- Drug Combinations
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Toxicological Effects
- Caution and personalized dose adjustment in patients with the following genotypes
- Other genes that may be involved
- Substrate of
- Inhibits
- Induces
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Apteor, Fenolip, Lipanthyl, Lipcor, Lipsin; Belgium: Fenofibrate, Fenogal, Fenosup, Lipanthylnano; Bulgaria: Lipanthyl; Cyprus: Lipidil; Czech Republic: Apo-Feno, Febira, Fenofix, Lipanthyl, Lipirex, Lipohexal, Supralip; Estonia: Fenolip, Lipanthyl; Finland: CiL, Lipanthyl; France: Fegenor, Fenofibrate, Lipanthyl, Secalip; Germany: Apteor, CiL, Durafenat, Elipsia, Fenobeta, Fenofanton, Fenofibrat, Fenofibrate, Lipanthyl, Liperial, Lipidil, Lipilo, Lofat, Normalip Pro, Xafenor; Greece: Fenofibrate, Planitrix, Xafenor; Hungary: Fenobrat, Fenofibrate, Fenoswiss, Lipanthyl NT, Lipidil; Ireland: Lipantil; Italy: Fenofibrato, Fulcro, Liperial, Lipofene, Lipsin, Nolipax, Tilene; Latvia: Fenolip, Lipanthyl; Lithuania: Fenolip, Lipanthyl; Luxembourg: Fenofibrat, Lipanthyl; Malta: Fenofibrate, Fulcro, Lipanthyl; Poland: Apo-Feno, Fenardin, Fenoratio, Fenovax, Grofibrat, Lipanthyl, Xafenor; Portugal: Apteor, Catalip, Fenofibrato, Lipanthyl, Lipofene, Supralip; Romania: Fenofibrat, Fenox, Lipanthyl, Lipantil, Lipivin, Lipofib, TriCor; Slovakia: Febira, Fenofibrate, Fenofix, Fenolip, Lipanthyl, Supralip; Slovenia: Katalip; Spain: Fenofibrato, Liparison, Secalip; Sweden: Fulcro, Lipanthyl; UK: Fenofibrate, Lipantil, Supralip.
North America
Canada: Apo-Feno-Micro, Fenofibrate, Lipidil, Pro-Feno-Super; USA: Antara, Fenofibrate, Fenoglide, Lipofen, TriCor, Triglide.
Latin America
Argentina: Fenobrate, Procetoken, Sclerofin UD; Brazil: Lipanon, Lipidil; Mexico: Controlip, Lipidil.
Asia
Japan: Lipidil, TriCor.
Drug combinations
Fenofibrate and Ezetimibe
Chemistry
Fenofibrate: C~20~H~21~ClO~4~. Mw: 360.83. Isopropyl 2-[p-(p-chlorobenzoyl)phenoxy]-2-methylpropionate. CAS-49562-28-9 (1976).
Pharmacologic Category
Antilipemic Agents; Fibric Acid Derivatives. (ATC-Code: C10AB05).
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%-60%. Modest increase in HDL occurs in some hypertriglyceridemic patients.
Therapeutic use
Adjunct to dietary therapy to decrease elevated serum total and LDL-C, triglyceride, and apolipoprotein B (APOB) concentrations, and to increase HDL-C concentrations in the management of primary hypercholesterolemia and mixed dyslipidemia, including heterozygous familial hypercholesterolemia and other causes of hypercholesterolemia. Additive antilipemic effects when used concomitantly with other antilipemic agents (e.g. colesevelam, ezetimibe). Adjunct to dietary therapy in management of hypertriglyceridemia.
Pregnancy and lactiation implications
Animal studies have shown embryocidal and teratogenic effect. There are no adequate, well-controlled studies in pregnant women. Use should be avoided, if possible, in pregnant women since the neonatal glucuronide conjugation pathways are immature. Not recommended during lactation.
Unlabeled use
Contraindications
Hypersensitivity to fenofibrate or any component of the formulation.
Warnings and precautions
May cause cholelithiasis. May cause mild to moderate decreases in hemoglobin, hematocrit and WBC upon initiation of therapy. Hepatic transaminases can become significantly elevated (dose-related). Hepatocellular, chronic active, and cholestatic hepatitis reported. Rarely hypersensitivity reactions (e.g. severe skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis) may occur. Associated with rare myositis or rhabdomyolysis. Use associated with pulmonary embolism and deep vein thrombosis. Use with caution in risk factors for venous thromboembolism, and in mild-to-moderate renal impairment. Contraindicated with severe renal impairment (CrCl ≤30 mL/minute). Use caution with HMG-CoA reductase inhibitors (may lead to myopathy, rhabdomyolysis). Use with caution in patients taking warfarin. Use with caution in the elderly (higher incidence of renal impairment). Therapy should be withdrawn if adequate response not obtained after 2 months of therapy at maximal daily dose. Occurrence of pancreatitis may represent failure of efficacy in severely elevated triglycerides.