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Fenofibrate: Drug information

Fenofibrate: Drug information
(For additional information see "Fenofibrate: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Antara;
  • Fenoglide;
  • Fibricor;
  • Lipofen;
  • Tricor;
  • Triglide [DSC];
  • Trilipix
Brand Names: Canada
  • AA-Feno-Micro;
  • AA-Feno-Super;
  • APO-Fenofibrate [DSC];
  • Feno-Micro-200 [DSC];
  • Fenofibrate Micro;
  • Fenomax [DSC];
  • Lipidil EZ;
  • Lipidil Supra;
  • MINT-Fenofibrate E [DSC];
  • PMS-Fenofibrate [DSC];
  • PRO-Feno-Super-100 [DSC];
  • PRO-Feno-Super-160 [DSC];
  • RATIO-Fenofibrate MC [DSC];
  • SANDOZ Fenofibrate E;
  • SANDOZ Fenofibrate S [DSC];
  • TARO-Fenofibrate E
Pharmacologic Category
  • Antilipemic Agent, Fibric Acid
Dosing: Adult
Hypertriglyceridemia

Hypertriglyceridemia (adjunctive agent):

Note: All patients should receive general measures (ie, address modifiable causes, manage atherosclerotic cardiovascular disease [ASCVD] risk, implement lifestyle modification [eg, dietary changes, reduction of alcohol consumption]) and optimal low-density lipoprotein–lowering therapy for 4 to 12 weeks before considering triglyceride-lowering therapy. For patients whose triglycerides remain ≥500 mg/dL and who do not warrant icosapent ethyl for additional ASCVD risk reduction, either a fibrate (fenofibrate preferred) or any prescription strength omega-3 fatty acid (including icosapent ethyl) is reasonable (Ref).

Oral:

Fenofibrate and Derivatives Hypertriglyceridemia Dosing

Formulation

Products

Available strengths

Dosage range

Maximum dose

Capsule, choline fenofibrate

Trilipix and generics

45 mg, 135 mg

45 to 135 mg once daily with or without food

135 mg/day

Capsule, micronized

Antara and generics

30 mg, 90 mg

30 to 90 mg once daily with or without food

90 mg/day

Generics

43 mg, 130 mg

43 to 130 mg once daily with or without food

130 mg/day

Generics

67 mg, 134 mg, 200 mg

67 to 200 mg once daily with food

200 mg/day

Capsule, nonmicronized

Lipofen and generics

50 mg, 150 mg

50 to 150 mg once daily with food

150 mg/day

Tablet, fenofibric acid

Fibricor and generics

35 mg, 105 mg

35 to 105 mg once daily with or without food

105 mg/day

Tablet, microcoated

Lipidil Supra [Canadian product] and generics

100 mg, 160 mg

160 to 200 mg once daily with food

200 mg/day

Tablet, nanocrystal

TriCor and generics

48 mg, 145 mg

48 to 145 mg once daily with or without food

145 mg/day

Lipidil EZ [Canadian product] and generics

48 mg, 145 mg

145 mg once daily with or without food

145 mg/day

Tablet, nonmicronized

Fenoglide and generics

40 mg, 120 mg

40 to 120 mg once daily with food

120 mg/day

Generics

54 mg, 160 mg

54 to 160 mg once daily with food

160 mg/day

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Fenofibrate use has been associated with reversible elevations in serum creatinine, although the clinical significance is unknown. If creatinine levels are significantly elevated with fibrate therapy and no other clinically relevant cause is evident, then interruption of therapy may be warranted (Ref).

Altered kidney function:

Note: Multiple formulations available. The following recommendations are considered applicable to all formulations (Ref).

CrCl >80 mL/minute: No dosage adjustment necessary.

CrCl >30 to 80 mL/minute: Use lowest available tablet strength (if a formulation is not available in a strength that is ≤67 mg, then an alternate formulation should be used); do not titrate (Ref).

CrCl ≤30 mL/minute: Use contraindicated.

Hemodialysis, intermittent (thrice weekly): Not dialyzable (Ref): Use is contraindicated.

Peritoneal dialysis: Not likely to be dialyzable: Avoid use (Ref).

CRRT: Not likely to be significantly removed; avoid use (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Not likely to be significantly removed; avoid use (Ref).

Dosing: Hepatic Impairment: Adult

Use is contraindicated. Regular monitoring of LFTs is required; drug-induced liver injury has been reported in postmarketing studies with some formulations resulting in liver transplantation or death. Discontinue therapy in patients with signs/symptoms of liver injury or whose enzyme levels persist above 3 times the ULN or accompanied by elevated bilirubin. Do not restart if there is no other explanation for liver injury.

Dosing: Older Adult

Initial: Adjust dosage based on kidney function; additional product-specific recommendations for initial dose:

Fenofibrate, micronized capsule (available strengths: 67 mg, 134 mg, 200 mg): Oral: 67 mg once daily.

Lipidil EZ [Canadian product] (available strengths: 48 mg, 145 mg): Oral: 48 mg once daily.

Dosing: Adjustment for Toxicity: Adult

Cholelithiasis: Discontinue if gallstones are found upon gallbladder studies.

CPK elevation, myopathy, and/or myositis: Discontinue therapy if the patient develops markedly elevated CPK concentrations or if myopathy/myositis is suspected or diagnosed.

HDL-C reductions: Permanently discontinue therapy if HDL-C becomes severely depressed; monitor HDL-C concentrations until returned to baseline.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as fenofibrate:

Antara: 30 mg [contains fd&c blue #2 (indigotine), quinoline yellow (d&c yellow #10)]

Antara: 90 mg [contains fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10)]

Lipofen: 50 mg [contains fd&c blue #1 (brilliant blue), fd&c blue #2 (indigotine), fd&c red #40 (allura red ac dye), quinoline yellow (d&c yellow #10)]

Lipofen: 150 mg [DSC]

Lipofen: 150 mg [contains fd&c blue #1 (brilliant blue), fd&c blue #2 (indigotine), fd&c red #40 (allura red ac dye), quinoline yellow (d&c yellow #10)]

Generic: 30 mg, 43 mg, 50 mg, 67 mg, 90 mg, 130 mg, 134 mg, 150 mg, 200 mg

Capsule Delayed Release, Oral, as choline fenofibrate:

Trilipix: 45 mg

Trilipix: 135 mg [contains fd&c blue #2 (indigotine)]

Generic: 45 mg, 135 mg

Tablet, Oral, as fenofibrate:

Fenoglide: 40 mg, 120 mg

Tricor: 48 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]

Tricor: 145 mg [contains soybean lecithin]

Triglide: 160 mg [DSC] [contains egg phospholipids (egg lecithin)]

Generic: 40 mg, 48 mg, 54 mg, 120 mg, 145 mg, 160 mg

Tablet, Oral, as fenofibric acid:

Fibricor: 35 mg, 105 mg

Generic: 35 mg, 105 mg

Generic Equivalent Available: US

Yes

Dosage Forms Considerations

Micronized formulations: Antara.

Strength of choline fenofibrate products are expressed in terms of fenofibric acid.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Fenomax: 100 mg [DSC]

Generic: 100 mg [DSC]

Capsule, Oral, as fenofibrate:

Generic: 67 mg, 200 mg

Tablet, Oral:

Generic: 100 mg

Tablet, Oral, as fenofibrate:

Lipidil EZ: 48 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake, soybean lecithin]

Lipidil EZ: 145 mg [contains soybean lecithin]

Lipidil Supra: 160 mg [contains soybean lecithin]

Generic: 48 mg, 145 mg, 160 mg

Administration: Adult

Oral:

Antara, fenofibrate (micronized), Fibricor, Lipidil EZ [Canadian product], TriCor, Triglide, Trilipix: Administer with or without food. Swallow whole; do not open (capsules), crush, dissolve, or chew.

Fenoglide, Lipofen, Lipidil Supra [Canadian product]: Administer with meals. Swallow whole; do not open (capsules), crush, dissolve, or chew.

Bariatric surgery: Capsule, delayed release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Delayed-release capsules should not be opened. Switch to a formulation that is not delayed release at the nearest possible dose in a tablet or capsule and either crush or open as appropriate.

Use: Labeled Indications

Hypertriglyceridemia: Adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia (Fredrickson types IV and V hyperlipidemia).

Medication Safety Issues
Sound-alike/look-alike issues:

Fibricor may be confused with Tricor

TriCor may be confused with Fibricor, Tracleer

TriLipix may be confused with Trileptal, TriLyte

Adverse Reactions (Significant): Considerations
Hepatic effects

Increased serum aminotransferases (increased serum alanine aminotransferase (ALT) and increased serum aspartate aminotransferase) and hepatotoxicity have been reported (Ref). Liver injury has ranged from hepatocellular hepatitis to cholestatic hepatitis or mixed hepatitis (Ref). Acute cholestatic hepatitis, hepatic cirrhosis, and hepatitis with autoimmune features have also been described (Ref). Increased serum aminotransferases are usually mild and transient but may require drug discontinuation if levels persist above 3 times the upper limit of normal (Ref); ALT elevations normalize within 2 to 4 weeks after discontinuation (Ref). In patients with hepatotoxicity, serum aminotransferase levels generally fall to normal within 2 to 12 months after discontinuation (Ref), although some patients may have progressive cholestasis and hepatic failure that may require liver transplantation (Ref). There is an increased risk of liver toxicity with fenofibrate compared to gemfibrozil (Ref).

Mechanism: Unknown: Non–dose-related; possibly immune-mediated response (Ref)

Onset: Varied; duration of therapy prior to onset of hepatotoxicity ranges from 1 to 8 weeks to several months, although may occur earlier (after 2 days) or after years of treatment (Ref).

Risk factors:

• HLA-A*33:01 (Ref)

Hypersensitivity reactions (delayed)

A variety of delayed hypersensitivity reactions, ranging from mild maculopapular skin rash (Ref) to severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome and toxic epidermal necrolysis (Ref), drug rash with eosinophilia and systemic symptoms (Ref), and acute generalized exanthematous pustulosis (Ref) may occur.

Mechanism: Non–dose-related; immunologic (ie, T-cell mediated) (Ref)

Onset: Varied; maculopapular rash may occur within 1 to 2 weeks after initiation (Ref). SCARs usually occur 1 to 8 weeks after initiation (Ref).

Risk factors:

• Cross-reactivity between fenofibrate and bezafibrate, but not gemfibrozil (Ref)

Myopathy/rhabdomyolysis

Myopathy and rhabdomyolysis have been reported with fibrates, including fenofibrate (Ref) when used as monotherapy or in combination with other agents (usually a statin) (Ref). There is an increased risk of myopathy and rhabdomyolysis with gemfibrozil compared to fenofibrate, especially when used in combination with a statin (Ref).

Mechanism: Unknown; may exacerbate latent preexisting mitochondrial myopathies, accelerate normal physiologic changes in skeletal muscle associated with aging, or may have a direct toxic action on muscle cells (Ref).

Onset: Varied; rhabdomyolysis has occurred from 3 days to 3 years (average time was 17.5 weeks) (Ref), with more rapid onset following rechallenges (Ref).

Risk factors:

• Concurrent diabetes, kidney failure, and/or hypothyroidism (Ref)

• Concurrent statin (Ref)

• Older age (Ref)

Photosensitivity

Skin photosensitivity may result in various cutaneous eruptions, including erythematous, eczematous, lichenoid, papulovesicular, and sunburn-like rashes (Ref).

Mechanism: Non–dose-related; idiosyncratic. May be due to the photoexcited benzophenone structure (Ref).

Onset: Varied; from 3 days to 4 weeks (Ref)

Risk factors:

• Cross-photosensitization between fenofibrate and ketoprofen due to structural similarities (Ref)

Renal effects

Increased serum creatinine has occurred with fibrates, including fenofibrate (Ref). In some patients, increases in serum creatinine may not result in significant changes in glomerular filtration rate (Ref). Acute kidney injury has also been reported, usually in association with rhabdomyolysis (Ref). Increase in serum creatinine is usually reversible with discontinuation (usually within 51 days) or in some patients with continued use of fenofibrate (Ref). There is an increased risk with fenofibrate compared to gemfibrozil (Ref).

Mechanism: Dose-related. Unknown; may impair production of vasodilatory prostaglandins due to activation of peroxisome proliferators-activated receptors. An induced elevation of the metabolic production rate of creatinine may occur in patients with isolated increases in serum creatinine (Ref).

Onset: Varied; increase in serum creatinine is usually observed within 20 days after initiation (Ref)

Risk factors:

• High-dose fenofibrate (≥145 mg/day), especially in patients with underlying kidney impairment (Ref)

• Preexisting kidney impairment, concurrent diabetes, patients with kidney transplant (Ref)

• Older age (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Hepatic: Increased serum alanine aminotransferase (≥3 x ULN: ≤13%) (table 1), increased serum aspartate aminotransferase (≥3 x ULN: ≤13%) (table 2)

Fenofibrate and Derivatives: Adverse Reaction: Increased Serum Alanine Aminotransferase

Drug (Fenofibrate and Derivatives)

Placebo

Dose

Dosage Form

Number of Patients (Fenofibrate and Derivatives)

Number of Patients (Placebo)

Comments

13%

0%

Doses equivalent to 96 to 145 mg daily

N/A

N/A

N/A

ALT or AST elevations ≥3 x ULN

5%

1%

Doses equivalent to 96 to 145 mg daily

N/A

N/A

N/A

>3 x ULN

3%

2%

N/A

N/A

439

365

N/A

2%

0.2%

135 mg daily

Delayed-release capsules

N/A

N/A

ALT and AST elevations >3 x ULN

0%

N/A

Doses equivalent to ≤48 mg daily

N/A

N/A

N/A

ALT or AST elevations ≥3 x ULN

Fenofibrate and Derivatives: Adverse Reaction: Increased Serum Aspartate Aminotransferase

Drug (Fenofibrate and Derivatives)

Placebo

Dose

Dosage Form

Number of Patients (Fenofibrate and Derivatives)

Number of Patients (Placebo)

Comments

13%

0%

Doses equivalent to 96 to 145 mg daily

N/A

N/A

N/A

ALT or AST elevations ≥3 x ULN

3%

0.5%

N/A

N/A

439

365

N/A

2%

0.2%

135 mg daily

Delayed-release capsules

N/A

N/A

ALT and AST elevations >3 x ULN

0%

N/A

Doses equivalent to ≤48 mg daily

N/A

N/A

N/A

ALT or AST elevations ≥3 x ULN

1% to 10%:

Cardiovascular: Pulmonary embolism (1%)

Dermatologic: Skin rash (1%), urticaria (1%)

Gastrointestinal: Abdominal pain (5%), constipation (2%), diarrhea (≥3%), dyspepsia (≥3%)

Nervous system: Dizziness (≥3%), pain (≥3%)

Neuromuscular & skeletal: Arthralgia (≥3%), increased creatine phosphokinase in blood specimen (3%), limb pain (≥3%), myalgia (≥3%)

Respiratory: Nasopharyngitis (≥3%), rhinitis (2%), sinusitis (≥3%), upper respiratory tract infection (≥3%)

<1%: Renal: Increased serum creatinine (Kim 2017)

Postmarketing:

Dermatologic: Acute generalized exanthematous pustulosis (Morias 2008), skin photosensitivity (Tsai 2017), Stevens-Johnson syndrome (Kang 2019), toxic epidermal necrolysis (Kang 2019)

Endocrine & metabolic: Decreased HDL cholesterol (can be severe) (Mymin 2009)

Gastrointestinal: Pancreatitis (Chung 2018; Douros 2013)

Hematologic & oncologic: Agranulocytosis, anemia, thrombocytopenia (Agapakis 2015)

Hepatic: Cholestatic hepatitis (LiverTox 2017), hepatic cirrhosis (LiverTox 2017), hepatitis (including autoimmune and mixed) (LiverTox 2017), hepatocellular hepatitis (LiverTox 2017), hepatotoxicity (including acute and severe) (LiverTox 2017), increased serum bilirubin

Hypersensitivity: Anaphylaxis, angioedema

Immunologic: Drug reaction with eosinophilia and systemic symptoms (Kang 2019)

Nervous system: Headache

Neuromuscular & skeletal: Asthenia (Rabasa-Lhoret 2001), muscle spasm, myopathy, rhabdomyolysis (Zhou 2020)

Renal: Acute kidney injury (Zhou 2020)

Respiratory: Interstitial pulmonary disease

Contraindications

Hypersensitivity to fenofibrate or fenofibric acid or any component of the formulation; active liver disease, including primary biliary cirrhosis and unexplained, persistent liver function abnormality; severe kidney impairment or end-stage kidney disease, including those receiving dialysis; preexisting gallbladder disease; breastfeeding.

Documentation of allergenic cross-reactivity for fibrates is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Pregnancy; known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen; chronic or acute pancreatitis; patients <18 years of age; coadministration with HMG-CoA reductase inhibitors in patients with a predisposition for myopathy; allergy to soya lecithin, peanut or arachis oil, or related products (tablet formulations only).

Warnings/Precautions

Concerns related to adverse effects:

• Cholelithiasis: May cause cholelithiasis; discontinue if gallstones are found upon gallbladder studies.

• HDL cholesterol: A paradoxical, severe, and reversible decrease in HDL-C (as low as 2 mg/dL) with a simultaneous decrease in apolipoprotein A1 has been reported within 2 weeks to years after initiation of fibrate therapy; clinical significance unknown.

• Hematologic effects: May cause mild to moderate decreases in hemoglobin, hematocrit, and WBC upon initiation of therapy, which usually stabilizes with long-term therapy. Agranulocytosis and thrombocytopenia have been reported.

• Pancreatitis: Pancreatitis has been reported with fenofibrate use; may be secondary to a failure of efficacy in patients with severe hypertriglyceridemia, medication side effect, or due to biliary tract stone or sludge formation from bile duct obstruction.

• Venous thromboembolism: Use has been associated with pulmonary embolism and deep vein thrombosis. Use with caution in patients with risk factors for venous thromboembolism.

Disease-related concerns:

• Cardiovascular disease: Fibric acid derivatives have not demonstrated significant efficacy in altering cardiovascular disease mortality in major clinical studies. In two large randomized controlled clinical trials, neither fenofibrate monotherapy (Keech 2005) nor the addition of fenofibrate to simvastatin (ACCORD Study Group 2010) compared to placebo were shown to reduce cardiovascular disease morbidity and mortality in patients with type 2 diabetes.

• Hepatic impairment: Contraindicated in patients with active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities.

• Kidney impairment: Use with caution in patients with mild to moderate kidney impairment; dosage adjustment required. Contraindicated in patients with severe kidney impairment, including those receiving dialysis.

Concurrent drug therapy issues:

• HMG-CoA reductase inhibitors: Use caution with HMG-CoA reductase inhibitors. No incremental benefit of combination therapy on cardiovascular morbidity and mortality over statin monotherapy has been established. In combination with HMG-CoA reductase inhibitors, fenofibrate is generally regarded as safer than gemfibrozil due to limited pharmacokinetic interaction with statins. Fenofibrate may be considered in patients on low- or moderate-intensity statin therapy (ie, statin therapy intended to lower LDL-C by <30% or ~30% to 50%, respectively) only if the benefits from atherosclerotic cardiovascular disease risk reduction or triglyceride lowering when triglycerides are >500 mg/dL, outweigh the potential risk for adverse effects (ACC/AHA [Stone 2013]).

Special populations:

• Older adults: Use with caution in older adults; dosage adjustment may be required.

Dosage form specific issues:

• Peanut or arachis oil: Some products may contain peanut or arachis oil; use is contraindicated in patients with a peanut or arachis allergy for applicable formulations.

• Soya lecithin: Some products may contain soya lecithin; use is contraindicated in patients with a soya lecithin allergy for applicable formulations.

Other warnings/precautions:

• Optimal response: Therapy should be withdrawn if an adequate response is not obtained after 2 to 3 months of therapy at the maximal daily dose.

Metabolism/Transport Effects

Inhibits CYP2C9 (weak)

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acipimox: May enhance the myopathic (rhabdomyolysis) effect of Fibric Acid Derivatives. Risk C: Monitor therapy

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Fibric Acid Derivatives. Management: Separate doses by at least 2 hours to minimize this interaction; fenofibric acid labeling recommends administration one hour prior to or 4-6 hours after a bile acid sequestrant. Risk D: Consider therapy modification

Ciprofibrate: May enhance the adverse/toxic effect of Fibric Acid Derivatives. Risk X: Avoid combination

Colchicine: Fibric Acid Derivatives may enhance the myopathic (rhabdomyolysis) effect of Colchicine. Risk C: Monitor therapy

CycloSPORINE (Systemic): May enhance the nephrotoxic effect of Fibric Acid Derivatives. Fibric Acid Derivatives may decrease the serum concentration of CycloSPORINE (Systemic). Management: Careful consideration of the risks and benefits should be undertaken prior to use of this combination; extra monitoring of renal function and cyclosporine concentrations will likely be required. Adjustment of cyclosporine dose may be necessary. Risk D: Consider therapy modification

Ezetimibe: Fenofibrate and Derivatives may enhance the adverse/toxic effect of Ezetimibe. Specifically, the risk of myopathy and cholelithiasis may be increased. Fenofibrate and Derivatives may increase the serum concentration of Ezetimibe. Risk C: Monitor therapy

Fosphenytoin-Phenytoin: CYP2C9 Inhibitors (Weak) may increase the serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor therapy

HMG-CoA Reductase Inhibitors (Statins): Fenofibrate and Derivatives may enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Raltegravir: May enhance the myopathic (rhabdomyolysis) effect of Fibric Acid Derivatives. Risk C: Monitor therapy

Sulfonylureas: Fibric Acid Derivatives may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Tacrolimus (Systemic): May enhance the nephrotoxic effect of Fenofibrate and Derivatives. Risk C: Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Fibric Acid Derivatives may enhance the anticoagulant effect of Vitamin K Antagonists. Management: Consider reducing the oral anticoagulant dose by 25% to 33% when initiating a fibric acid derivative. Monitor for toxic or reduced anticoagulant effects if a fibric acid derivative is initiated/dose increased, or discontinued/dose decreased, respectively. Risk D: Consider therapy modification

Warfarin: Fenofibrate and Derivatives may enhance the anticoagulant effect of Warfarin. Fenofibrate and Derivatives may increase the serum concentration of Warfarin. Management: Monitor for signs and symptoms of bleeding, and increase INR monitoring in patients taking warfarin who are initiated on fenofibrate derivatives. Warfarin dose reductions will likely be required. Risk D: Consider therapy modification

Food Interactions

Antara (micronized): When administered under fasted conditions or with a low-fat meal, the extent of absorption and the time to peak did not change; however peak concentrations were increased in the presence of a low-fat meal. When administered with a high fat meal, a 26% increase in the AUC and 108% increase in the peak concentration were seen in comparison to the fasted state. Management: Administer with or without food.

Fenoglide: When administered with a high-fat meal, the peak concentration was increased by 44% as compared to fasting conditions. Management: Administer with meals.

Fibricor: When administered with a high-fat meal, the peak concentration was decreased by ~35% while AUC remained unchanged as compared to fasting conditions. Management: Administer with or without food.

Lipidil EZ [Canadian product]: Bioavailability was not significantly different when administered under fasting and nonfasting conditions. Management: Administer with or without food.

Lipidil Supra [Canadian product]: In general, fenofibrate absorption is low and variable when administered under fasting conditions; absorption is increased when administered with food. Management: Administer with meals.

Lipofen: When administered with a low-fat and high-fat meal, the extent of absorption is increased by ~25% and ~58%, respectively, as compared to fasting conditions. Management: Administer with meals.

TriCor: Peak concentrations and AUC were not significantly different when a single dose was administered under fasting and nonfasting conditions. Management: Administer with or without food.

Triglide: When administered with food, the rate of absorption was increased ~55% as compared to fasting conditions; the AUC remained unchanged. Management: Administer with or without food.

Trilipix: Peak concentrations and AUC were not significantly different when a single dose was administered under fasting and nonfasting conditions. Management: Administer with or without food.

Pregnancy Considerations

Triglyceride and lipid concentrations increase during pregnancy as required for normal fetal development. When increases are greater than expected, supervised dietary intervention should be initiated. In patients who are pregnant who develop severe hypertriglyceridemia and are at risk for pancreatitis, use of fenofibrate beginning in the second trimester is one intervention that may be considered. Agents other than fenofibrate should be used for hypercholesterolemia (Avis 2009; Berglund 2012; Jacobson 2015; Wong 2015).

Breastfeeding Considerations

It is not known if fenofibrate is present in breast milk.

Lipids are a normal component of breast milk and the fatty acid component is required for normal infant neurologic development. Maternal diet, as well as other factors, may influence the fatty acid composition (Innis 2014). When treatment for severe hypertriglyceridemia in breastfeeding patients at risk for pancreatitis is needed, therapy with fenofibrate may be considered (Jacobson 2015). When treatment is needed for other indications, agents other than fenofibrate are preferred (Jacobson 2015; NICE 2008). Due to the potential for serious adverse reactions in the breastfed infant (such as disrupting lipid metabolism), breastfeeding is contraindicated by the manufacturer; some products specifically do not recommend breastfeeding until 5 days after the last dose.

Dietary Considerations

Antara, Fibricor, Lipidil EZ [Canadian product], TriCor, Triglide, Trilipix: May be taken with or without food.

Fenoglide, Lipidil Supra [Canadian product], Lipofen: Take with meals.

Monitoring Parameters

Periodic blood counts during first year of therapy. Monitor lipid profile periodically, including HDL-C within a few months of initiation of therapy. Monitor LFTs at baseline and periodically during therapy. Monitor kidney function in patients with kidney impairment or in those at increased risk for developing kidney impairment. Monitor for signs/symptoms of myopathy, myositis, or rhabdomyolysis (eg, CPK elevation; muscle pain, tenderness, weakness, especially if accompanied with malaise or fever; brown urine).

Mechanism of Action

Fenofibric acid, an agonist for the nuclear transcription factor peroxisome proliferator-activated receptor-alpha (PPAR-alpha), downregulates apoprotein C-III (an inhibitor of lipoprotein lipase) and upregulates the synthesis of apolipoprotein A-I, fatty acid transport protein, and lipoprotein lipase resulting in an increase in VLDL catabolism, fatty acid oxidation, and elimination of triglyceride-rich particles; 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.

Pharmacokinetics

Absorption: Increased when taken with meals.

Distribution: Widely to most tissues.

Protein binding: ~99%.

Metabolism: Fenofibrate is metabolized in the tissue and plasma via esterases to the active form, fenofibric acid; fenofibric acid then undergoes inactivation by glucuronidation hepatically or renally.

Bioavailability: Fenofibric acid: ~81%.

Half-life elimination: Fenofibric acid: Mean: 20 hours (range: 10 to 35 hours); half-life prolonged in patients with kidney impairment.

Time to peak: 2 to 8 hours.

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

Pharmacokinetics: Additional Considerations

Altered kidney function: In patients with severe kidney impairment (CrCl ≤30 mL/minute), clearance of fenofibrate is greatly reduced. Clearance is reduced to a lesser degree in patients with mild to moderate kidney impairment (CrCl 30 to 80 mL/minute).

Pricing: US

Capsule, delayed release (Trilipix Oral)

45 mg (per each): $3.61

135 mg (per each): $10.83

Capsules (Antara Oral)

30 mg (per each): $6.90

90 mg (per each): $20.32

Capsules (Fenofibrate Micronized Oral)

30 mg (per each): $6.21

43 mg (per each): $2.27 - $2.35

67 mg (per each): $0.27 - $1.06

90 mg (per each): $18.29

130 mg (per each): $6.83 - $6.93

134 mg (per each): $0.45 - $1.96

200 mg (per each): $0.79 - $3.15

Capsules (Fenofibrate Oral)

50 mg (per each): $3.27

150 mg (per each): $7.16

Capsules (Lipofen Oral)

50 mg (per each): $4.35

150 mg (per each): $11.39

Tablets (Fenofibrate Oral)

40 mg (per each): $10.45 - $13.34

48 mg (per each): $1.91 - $2.29

54 mg (per each): $0.30 - $0.82

120 mg (per each): $31.34 - $40.03

145 mg (per each): $5.73 - $6.87

160 mg (per each): $0.61 - $2.88

Tablets (Fenofibric Acid Oral)

35 mg (per each): $11.84

105 mg (per each): $23.64

Tablets (Fenoglide Oral)

40 mg (per each): $14.84

120 mg (per each): $44.53

Tablets (Fibricor Oral)

35 mg (per each): $19.73

105 mg (per each): $39.40

Tablets (Tricor Oral)

48 mg (per each): $0.68

145 mg (per each): $1.24

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Apo-Feno (PL);
  • Apo-Feno-Micro (MY);
  • Biofibrat (PL);
  • Catalip (PT);
  • Cholecaps (ID);
  • Cholib (PH);
  • CIL (FI);
  • Controlip (AR, CR, DO, EC, GT, HN, MX, NI, PA, PE, SV);
  • Cordialibrel (MX);
  • Craveril (AR);
  • Daunlip (AR);
  • Diafeno (PH);
  • Durafenat (DE);
  • Eticer (CN);
  • Evothyl (ID);
  • Exlip (RU);
  • Febira (CZ);
  • Febira 200 (SK);
  • Febrate (TH);
  • Fegenor (FR, LB);
  • Fenacor (IN);
  • Fenardin (PL);
  • Fenatrol (BD);
  • Fenobrat (GR, HU, PE);
  • Fenobrate (AR);
  • Fenobraty (BR);
  • Fenocap (BD);
  • Fenocor (IN);
  • Fenofast (PH);
  • Fenofix (CZ, SK);
  • Fenoflex (ID, VN);
  • Fenogal (BE, GB, KW, LB, LU, PH, SA, TR);
  • Fenoget (LK, PK);
  • Fenogetz (VN);
  • Fenolip (AT, CO, EG, HR, IN, RO);
  • Fenopidil (KR);
  • Fenosup (BE, FI, MY, SG);
  • Fenosup Lidose (LB, VN);
  • Fenoswiss (HU);
  • Fenox (TH);
  • Fiba (LK);
  • Fibra (PK);
  • Fibrafen (PH);
  • Fibral (IN);
  • Fibranor (BG);
  • Fibrate (BD, IN);
  • Fibronil (CL);
  • Fulcro (IT);
  • Fulcrosupra (IT);
  • Grofibrat (PL);
  • Hafenthyl (VN);
  • Kemifib (EG);
  • Lexemin (HK, SG, TH);
  • Lifen (ID);
  • Lipanon (BR);
  • Lipanthyl (AE, BE, BG, CH, CN, CZ, DE, EE, EG, FI, FR, HK, JO, KW, LB, LT, LU, LV, MT, MY, PH, PL, QA, RO, RU, SA, SE, SG, SK, TH, TR, UA, VN, ZA);
  • Lipanthyl NT (VN);
  • Lipanthyl Penta 145 (HK);
  • Lipanthyl Supra (MY, SG);
  • Lipanthyl Supra 150 (HK);
  • Lipantil (GB, IE, RO);
  • Lipantil Supra (MT);
  • Lipcor (AT);
  • Liperial (IT);
  • Lipicard (IN, LK, UA);
  • Lipidil (AU, BR, DE, EC, GR, HR, HU, MX, TR);
  • Lipidil Supra (KR);
  • Lipidof (BD, PK);
  • Lipiduce (PH);
  • Lipifen T.U. (PY);
  • Lipilfen (CN, KR);
  • Lipilo (CN);
  • Lipired (BD);
  • Lipirex (CZ);
  • Lipivim (RO);
  • Lipofen (PT, TR, UA);
  • Lipofib (RO);
  • Lipsin (IT);
  • Lipway (PH);
  • Lofat (BD);
  • Lofibra (PH);
  • Lofibrate (TH);
  • Lolipid (BD);
  • Lotrilip (PH);
  • Lowpirol S (KR);
  • Minuslip (AR);
  • Nanofib (LB);
  • Nofibra (EG);
  • Nopid (KR);
  • Normalip (DE);
  • Normolip (CO, PE);
  • Notricol (CO);
  • Nubrex (PH);
  • Qi Shu (CN);
  • Qualipantyl (HK);
  • Redose (KR);
  • Reducofen (BR);
  • Sclerofin (AR);
  • Sclerofin UD (PY);
  • Secalip (ES, FR, TR);
  • Secalip Retard (ES);
  • Secalip Supra (ES);
  • Stanlip (BH, TH, VN);
  • Sulnit (PY);
  • Sulnit CD (PY);
  • Supralip (GB, PT);
  • Suprelip (CZ, SK);
  • Tilene (IT);
  • Tizabate (BD);
  • Trichek (LK, PH);
  • Tricor (HR, JP, RU, UA);
  • Trilipix (CH, CL, RU);
  • Trolip (ID, LK, PH, SG);
  • Ziglip (HR);
  • Zigotrig (HR);
  • Zinof (PH);
  • Zumafib (ID)


For country code abbreviations (show table)
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  12. Based on expert opinion.
  13. Based on manufacturer's labeling.
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  27. Fenofibrate capsules [prescribing information]. Weston, FL: Apotex Corp; June 2021.
  28. Fenofibrate capsules, USP [prescribing information]. East Windsor, NJ: Aurobindo Pharma USA Inc; September 2021.
  29. Fenofibrate tablets [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals Inc; February 2021.
  30. Fenoglide (fenofibric acid) [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals; June 2021.
  31. Fibricor (fenofibrate) tablets [prescribing information]. Athens, GA: Athena Bioscience LLC; June 2021.
  32. Gosho M. Rhabdomyolysis risk from the use of two-drug combination of antidyslipidemic drugs with antihypertensive and antidiabetic medications: a signal detection analysis. Fundam Clin Pharmacol. 2019;33(3):339-346. doi:10.1111/fcp.12435 [PubMed 30575126]
  33. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625 [PubMed 30586774]
  34. Hajdu D, Aiglová K, Vinklerová I, Urbánek K. Acute cholestatic hepatitis induced by fenofibrate. J Clin Pharm Ther. 2009;34(5):599-602. doi:10.1111/j.1365-2710.2009.01029.x [PubMed 19744016]
  35. He Y, Qin MZ, Chen YW. Liver injury caused by fenofibrate within 48 h after first administration: a case report. BMC Gastroenterol. 2021;21(1):298. doi:10.1186/s12876-021-01874-7 [PubMed 34325660]
  36. Holoshitz N, Alsheikh-Ali AA, Karas RH. Relative safety of gemfibrozil and fenofibrate in the absence of concomitant cerivastatin use. Am J Cardiol. 2008;101(1):95-97. doi:10.1016/j.amjcard.2007.07.057 [PubMed 18157972]
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  42. Kato K, Nagase A, Matsuda M, et al. Rhabdomyolysis associated with fenofibrate monotherapy in a patient with chronic myelogenous leukemia. Case Rep Gastroenterol. 2011;5(2):492-496. doi:10.1159/000331559 [PubMed 21960954]
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  49. Lipidil Supra (fenofibrate) tablets [product monograph]. Etobicoke, Ontario, Canada: BGP Pharma; January 2017.
  50. Lipofen (fenofibrate) capsules [prescribing information]. Baudette, MN: ANI Pharmaceuticals Inc; September 2021.
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  70. Tricor (fenofibrate) tablets [prescribing information]. North Chicago, IL: AbbVie Inc; June 2021.
  71. Triglide (fenofibric acid) [prescribing information]. East Brunswick, NJ: Casper Pharma LLC; June 2021.
  72. Trilipix (fenofibric acid) [prescribing information]. North Chicago, IL: AbbVie Inc; March 2021.
  73. Tsai KC, Yang JH, Hung SJ. Fenofibrate-induced photosensitivity - a case series and literature review. Photodermatol Photoimmunol Photomed. 2017;33(4):213-219. doi:10.1111/phpp.12305 [PubMed 28317179]
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  76. Wang D, Wang Y. Fenofibrate monotherapy-induced rhabdomyolysis in a patient with hypothyroidism: a rare case report and literature review. Medicine (Baltimore). 2018;97(14):e0318. doi:10.1097/MD.0000000000010318 [PubMed 29620657]
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  78. Wong SX, Tham MY, Goh CL, Cheong HH, Chan SY. Spontaneous cutaneous adverse drug reaction reports-an analysis of a 10-year dataset in Singapore. Pharmacol Res Perspect. 2019;7(2):e00469. doi:10.1002/prp2.469 [PubMed 30911397]
  79. Wu J, Song Y, Li H, Chen J. Rhabdomyolysis associated with fibrate therapy: review of 76 published cases and a new case report. Eur J Clin Pharmacol. 2009;65(12):1169-1174. doi:10.1007/s00228-009-0723-7 [PubMed 19756555]
  80. Zhou J, Li D, Cheng Q. Fenofibrate monotherapy-induced rhabdomyolysis in a patient with post-pancreatitis diabetes mellitus: a rare case report and a review of the literature. Medicine (Baltimore). 2020;99(21):e20390. doi:10.1097/MD.0000000000020390 [PubMed 32481339]
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