Adult Dosing

Primary hypercholesterolemia

Fenofibrate, Lofibra

• Start dose: 160 mg PO daily
• Max: 160 mg/day
• Start 54 mg PO daily and if essential increase q4-8 wks in geriatrics

Fenoglide

• Start dose: 120 mg PO daily

Lipofen

• Start dose: 150 mg PO daily
• Max: 150 mg/day
• Start 50 mg PO daily and if essential increase q4-8 wks in geriatrics

Tricor

• Start dose: 145 mg PO daily
• Max: 145 mg/day
• Start 48 mg PO daily and if essential increase q4-8 wks in geriatrics

Triglide

• Start dose: 160 mg PO daily
• Max: 160 mg/day
• Start 50 mg PO daily and if essential increase q4-8 wks in geriatrics

Mixed dyslipidemia

Fenofibrate, Lofibra

• Start: 160 mg PO daily
• Max: 160 mg/day
• Start 54 mg PO qd and if essential increase q4-8 wks in geriatrics

Fenoglide

• Start dose: 120 mg PO daily

Lipofen

• Start dose: 150 mg PO daily
• Max: 150 mg/day
• Start 50 mg PO qd and if essential increase q4-8 wks in geriatrics

Tricor

• Start dose: 145 mg PO daily
• Max: 145 mg/day
• Start 48 mg PO daily and if essential increase q4-8 wks in geriatrics

Triglide

• Start dose: 160 mg PO daily
• Max: 160 mg/day
• Start 50 mg PO daily and if essential increase q4-8 wks in geriatrics

Hypertriglyceridemia

Fenofibrate, Lofibra

• 54-160 mg PO daily
• Start 54-160 mg PO daily and if essential increase q4-8 wks
• Max: 160 mg/day
• Start 54 mg PO daily in geriatrics

Fenoglide

• 40-120 mg PO daily
• Start 40-120 mg PO daily and if essential increase q4-8 wks
• Max: 120 mg/day

Lipofen

• 50-150 mg PO daily
• Start 50-150 mg PO daily and if essential increase q4-8 wks
• Max: 150 mg/day
• Start 50 mg PO daily in geriatrics

Tricor

• 48-145 mg PO daily
• Start 48-145 mg PO daily and if essential increase q4-8 wks
• Max: 145 mg/day
• Start 48 mg PO daily in geriatrics

Triglide

• 50-160 mg PO daily
• Start 50-160 mg PO daily and if essential increase q4-8wk
• Max: 160 mg/day
• Start 50 mg PO daily in geriatrics

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• As an adjunctive therapy to diet for the reduction of LDL-C, Total-C, triglycerides and apo B and for increasing HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia when response to diet and non-pharmacological interventions alone is inadequate
• As an adjunctive therapy to diet for treatment of patients with hypertriglyceridemia

• Hypersensitivity to any of the ingredients of the product
• Hepatic or severe renal dysfunction
• Primary biliary cirrhosis
• Unexplained persistent liver function abnormality
• Preexisting gallbladder disease
• Pregnancy
• Breastfeeding

• N/A

Renal Dose Adjustment (Based on CrCl)

• Fenofibrate, Lofibra
• <50 mL/min: Contraindicated
• 50-90 mL/min: Start 54 mg PO daily

• Fenoglide
• <30 mL/min: Contraindicated
• 30-80 mL/min: Start 40 mg PO daily

• Lipofen, Triglide
• <50 mL/min: Contraindicated
• 50-90 mL/min: Start 50 mg PO daily

• Tricor
• <30 mL/min: Contraindicated
• 30-80 mL/min: Start 48 mg PO daily

Hepatic Dose Adjustment

• Hepatic impairment: Contraindicated

See Supplemental Patient Information

• Doses equivalent to 96-145 mg are associated with increasing serum transaminases levels. Increase in transaminase levels are dose dependent. Hepatocellular, chronic active and cholestatic hepatitis have occurred after exposures of therapy for weeks to several years. Rare occasions of cirrhosis have been reported in association with chronic active hepatitis. Regularly periodically monitor liver function including serum ALT (SGPT). Perform such tests for the duration of therapy. Discontinue therapy if enzyme levels persist >3x the normal limit
• Conduct gallbladder studies on suspection of cholelithiasis. Discontinue therapy on presence of gallstones
• Exercise caution when anticoagulants are administered in conjunction with fenofibrate capsules. Reduce the dosage of the anti-coagulant for maintaining the prothrombin time/INR at the desired level for prevention of bleeding complications. Frequently monitor prothrombin time/INR until it is definitely determined that the prothrombin time/INR has stabilized
• Rare occasions of myositis, myopathy, or rhabdomyolysis have occurred. Medically evaluate patients complaining of muscle pain, tenderness, or weakness for myopathy, serum creatine kinase level. On suspection or diagnosis of myopathy/myositis cease therapy with fenofibrate capsules
• Effect on coronary heart disease morbidity and mortality and non-cardiovascular mortality have not been established
• Perform laboratory tests before instituting fenofibrate therapy. Maintenance of serum lipids can be achieved with appropriate diet, exercise, weight loss in obese patients, and control of any medical conditions such as diabetes mellitus and hypothyroidism
• Discontinue medications or if feasible change them prior to consideration of triglyceride-lowering as exacerbation of hypertriglyceridemia have occurred
• Periodically determine serum lipids during initial therapy for establishing the lowest effective dose. Withdraw therapy in patients having inadequate response after 2 months of therapy with the maximum recommended dose of 145 mg/day
• Pancreatitis has occurred in association with failure of efficacy in patients with severe hypertriglyceridemia or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct
• Rare occasions of acute hypersensitivity reactions including severe skin rashes requiring patient hospitalization has occurred
• Hematologic changes have occurred following initiation of fenofibrate therapy. Periodically determine blood counts during the first 12 months of therapy with fenofibrate
• Occasions of myopathy has occurred. Rare occasions of rhabdomyolysis have occurred in patients with impaired renal function. Consider myopathy in patients with diffuse myalgias, muscle tenderness or weakness, and/or marked elevations of creatine phosphokinase levels
• Assess CPK levels in patients reporting unexplained muscle pain, tenderness or weakness, and discontinue fenofibrate therapy on marked elevated CPK levels or diagnoses of myopathy
• Fatal or nonfatal pulmonary embolism or thrombophlebitis have occurred in some patients
• Elevations in serum creatinine have occurred in patients on fenofibrate
• Severe decrease in HDL levels is reported in diabetic and non-diabetic patients according to the postmarketing and clinical trial reports. Monitor HDL levels for few months after initiation of therapy. If HDL level decreases withdraw therapy and monitor the level until it returns to baseline

Cautions: Us cautiously in

• Renal impairment
• Concurrent nephrotoxic agents
• Geriatrics

Supplemental Patient Information

• Advise patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever

Fenoglide, Lipofen, Lofibra, Tricor, Triglide interacts with :

	Acenocoumarol
	Coumadin
	Jantoven
	Warfarin

Pregnancy Category:C

Breastfeeding: Relevant published information on the use of fenofibrate during breastfeeding is unavailable. Prefer an alternate drug especially while nursing a newborn or preterm infant. This information is (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 9 March 2011). Avoid using this drug in nursing mothers. Manufacturer advises to make a decision for discontinuing nursing or to discontinue the drug.

• HEPA: Hepatitis, cirrhosis, elevated liver transaminases, abnormal LFTs
• GI: Cholelithiasis, pancreatitis, abdominal pain, nausea, constipation
• CNS: Headache, asthenia
• MUSC: Myositis, myopathy, rhabdomyolysis, back pain, elevated CK
• RESP: Respiratory disorders, rhinitis
• DERM: Stevens-Johnson syndrome, toxic epidermal necrolysis
• HEMA: Thrombocytopenia, agranulocytosis
• CV: Thromboembolism
• MISC: Hypersensitivity, flu syndrome

• Antihyperlipidemic; precise mechanism of action unknown; activates peroxisome proliferator activated receptors, inhibits synthesis of triglyceride and stimulates catabolism of triglyceride-rich lipoproteins
• Well absorbed from the GI tract
• Undergoes glucuronidation; CYP450: 2A6 (weak), 2C8 (weak), 2C19 (weak), 2C9 (mild-moderate)
• Excreted in urine (60%), feces (25%)
• Half-life: 23 hrs

US Trade Name(s)

• Fenoglide
• Lipofen
• Tricor
• Triglide
• Lofibra

US Availability

fenofibrate (generic)

• CAPS: 43, 130 mg
• TABS: 48, 54, 107, 145, 160 mg

Fenoglide

• TABS: 40, 120 mg

Lipofen

• CAPS: 50, 150 mg

Tricor

• TABS: 48, 145 mg

Triglide

• TABS: 50, 160 mg

Lofibra

• TABS: 54, 160 mg

Canadian Trade Name(s)

• Fenosuper
• Fenomax
• Lipidil

Canadian Availability

fenofibrate (generic)

• CAPS: 100 mg

Fenosuper

• TABS: 100, 160, 200 mg

Fenomax

• CAPS: 100, 160 mg

Lipidil

• TABS: 48, 145 mg

UK Trade Name(s)

• Supralip

UK Availability

fenofibrate (generic)

• CAPS: 267 mg

Supralip

• TABS: 160 mg

Australian Trade Name(s)

• Lipidil

Australian Availability

Lipidil

• TABS: 48, 145 mg

[Outline]

Endocrine/Metabolic

Antihyperlipidemic Agents

Fibric Acid Derivatives

Cardiovascular

Antihyperlipidemic Agents

Fibric Acid Derivatives

Pricing data from www.DrugStore.com in U.S.A.

• Tricor 48 MG TABS [Bottle] (ABBOTT)
  30 mg = $62.99
  90 mg = $164.97
• Lofibra 160 MG TABS [Bottle] (GATE)
  30 mg = $105.59
  90 mg = $296.97
• Lipofen 150 MG CAPS [Bottle] (KOWA PHARMACEUTICALS AMERICA)
  90 mg = $351
  270 mg = $1000.94
• Fenoglide 120 MG TABS [Bottle] (SHORE THERAPEUTICS)
  30 mg = $215.99
  90 mg = $635.94
• Tricor 145 MG TABS [Bottle] (ABBOTT)
  30 mg = $176.98
  90 mg = $484.99
• Triglide 160 MG TABS [Bottle] (SHIONOGI PHARMA)
  30 mg = $195.99
  90 mg = $539.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Fenoglide 120 MG Oral Tablet (Physicians Total Care, Inc.)
• Fenoglide 120 MG Oral Tablet (Sciele Pharma, Inc.)
• Fenoglide 40 MG Oral Tablet (Sciele Pharma, Inc.)
• Lipofen 150 MG Oral Capsule (Kowa Pharmaceuticals America Inc.)
• Lipofen 50 MG Oral Capsule (Kowa Pharmaceuticals America Inc.)
• Tricor (FENOFIBRATE 145 mg) (Physicians Total Care, Inc.)
• Tricor (FENOFIBRATE 160 mg) (Physicians Total Care, Inc.)
• Tricor (FENOFIBRATE 48 mg) (Physicians Total Care, Inc.)
• Tricor 145 MG Oral Tablet (A-S Medication Solutions LLC)
• Tricor 145 MG Oral Tablet (Abbott Laboratories)
• Tricor 48 MG Oral Tablet (Abbott Laboratories)
• Triglide 160 MG Oral Tablet (First Horizon Pharmaceutical)
• Triglide 160 MG Oral Tablet (Sciele Pharma, Inc.)
• Triglide 50 MG Oral Tablet (First Horizon Pharmaceutical)
• Triglide 50 MG Oral Tablet (Sciele Pharma, Inc.)