Dosing & Uses
Dosage Forms & Strengths
capsule (Antara)
- 30mg
- 90mg
capsule (fenofibrate, micronized)
- 43mg
- 130mg
capsule (Lofibra)
- 67mg
- 134mg
- 200mg
Hypertriglyceridemia
Indicated as adjunct to diet for severe hypertriglyceridemia (>500 mg/dL)
Individualize dose according to patient response
Antara: 30-90 mg PO qDay
Fenofibrate (micronized): 43-130 mg PO qDay; not to exceed 130 mg/day
Lofibra capsules: 67-200 mg PO qDay
Primary Hypercholesterolemia or Mixed Lipidemia
Indicated as adjunct to diet to reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia
Antara: 90 mg PO qDay initially; discontinue if inadequate response after 2 months of treatment; may decrease dose if patient responds
Fenofibrate (micronized): 130 mg PO qDay; not to exceed 130 mg/day
Lofibra capsules: 200 mg PO qDay
Dosage Modifications
Renal impairment
- Mild-to-moderate (CrCl 30-80 mL/min): Initiate at lowest available dose and increase only after evaluating effects on renal function and lipid levels
- Severe (CrCl <30 mL/min): Contraindicated
Dosing Considerations
Hypertriglyceridemia: Improving glycemic control in diabetic patients with fasting chylomicronemia will usually obviate the need for pharmacological intervention
Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus
Administration
Antara: May take with or without meals
Lofibra capsules: Take with meals to optimize bioavailability
Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
1-10%
Abdominal pain (4.6%)
Back pain (3.4%)
Increased AST (3.4%)
Headache (3.2%)
Increased ALT (3%)
Increased CPK (3%)
Nausea (2.3%)
Constipation (2.1%)
Postmarketing Reports
Myalgia, rhabdomyolysis, muscle spasms, arthralgia
Pancreatitis
Renal failure
Hepatitis, cirrhosis
Anemia
Severely depressed HDL levels
Photosensitivity reactions (may occur days to months after initiating therapy)
Interstitial lung disease
Increase total bilirubin
Asthenia
Warnings
Contraindications
Hypersensitivity
Severe renal impairment (including dialysis)
Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities
Pre-existing gallbladder disease
Breastfeeding women
Cautions
Effect on coronary heart disease morbidity and mortality not established
Increases risk of myositis or myopathy, and has been associated with rhabdomyolysis; risk may increase when coadministered with statins
Higher doses or coadministration with statins associated with increased serum transaminases
May increase serum creatinine; monitor renal function periodically in patients with renal impairment
May increase cholesterol excretion in bile, potentially leading to cholelithiasis
Coadministration with warfarin may increase anticoagulant effects resulting in PT/INR prolongation
Pancreatitis reported; may be a failure of efficacy with severe hypertriglyceridemia, a direct drug effect, or secondary effect via biliary stone or sludge formation
May decrease hemoglobin, hematocrit, and leukocytes; thrombocytopenia and agranulocytosis reported; monitoring of blood counts recommended during first year of therapy
Anaphylaxis and angioedema reported; if patient develops signs or symptoms of acute hypersensitivity reaction, advise them to seek immediate medical attention and discontinue therapy Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), reported postmarketing, occurring days to weeks after initiation of therapy; cases of DRESS associated with cutaneous reactions (such as rash exfoliative dermatitis) and a combination of eosinophilia, fever, systemic organ involvement (renal, hepatic, or respiratory); discontinue therapy and treat patients appropriately if SCAR is suspected
PE and DVT reported; use caution in patients with risk factors for VTE
Paradoxical decreases in HDL cholesterol reported; monitor HDL-C within few months of initiating therapy; discontinue of HDL-C becomes severely depressed; do not restart therapy
Hepatotoxicity
- Serious drug-induced liver injury (DILI), including liver transplantation and death, reported; DILI reported within first few weeks of treatment or after several months of therapy and in some cases has reversed with discontinuation of treatment
- Patients with DILI have experienced signs and symptoms including dark urine, abnormal stool, jaundice, malaise, abdominal pain, myalgia, weight loss, pruritus, and nausea
- Many patients had concurrent elevations of total bilirubin, serum alanine transaminase (ALT), and aspartate transaminase (AST)
- DILI has been characterized as hepatocellular, chronic active, and cholestatic hepatitis, and cirrhosis has occurred in association with chronic active hepatitis
- In clinical trials, fenofibrate at doses equivalent to 90 mg daily associated with increases in serum AST or ALT; the incidence of increases in transaminases may be dose-related
- Monitor patient’s liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for duration of therapy
- Discontinue therapy if signs or symptoms of liver injury develop or if elevated enzyme levels persist (ALT or AST > 3 times the upper limit of normal, or if accompanied by elevation of bilirubin); do not restart therapy in these patients if there is no alternative explanation for the liver injury
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Contraindicated
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Fenofibrate is a prodrug that is metabolized to the active moiety, fenofibric acid
Activates peroxisome proliferator activated receptor-alpha (PPAR-alpha); increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reduces Apo CIII production (lipoprotein lipase inhibitor)
Reduces TC, LDL-C, Apo B, TG, and VLDL; increases HDL-C, Apo AI, and Apo AII
Absorption
Peak Plasma Time: 4-8 hr (fenofibric acid)
Distribution
Time to steady-state: within 7 days (Antara); within 5 days (Lofibra capsules)
Protein Bound: 99%
Metabolism
Fenofibrate converted by ester hydrolysis to fenofibric acid (active moiety)
Fenofibric acid is primarily conjugated with glucuronic acid; a small amount is reduced at the carbonyl moiety to a benzhydrol metabolite which is, in turn, conjugated with glucuronic acid
Elimination
Half-life: 20-23 hr
Excretion: 66% in urine, primarily as fenofibric acid and fenofibric acid glucuronide; 25% feces
Pharmacogenomics
Genotyping patients with atherogenic dyslipidemia might establish who will benefit most from therapy with fenofibric to increase HDL-C
Three single-nucleotide polymorphisms (SNPs) in the APOA5 region have been associated with increases in HDL-C
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Tricor oral - | 145 mg tablet | ![]() | |
Tricor oral - | 48 mg tablet | ![]() | |
Antara oral - | 90 mg capsule | ![]() | |
fenofibrate micronized oral - | 130 mg capsule | ![]() | |
fenofibrate micronized oral - | 200 mg capsule | ![]() | |
fenofibrate micronized oral - | 67 mg capsule | ![]() | |
fenofibrate micronized oral - | 43 mg capsule | ![]() | |
fenofibrate micronized oral - | 130 mg capsule | ![]() | |
fenofibrate micronized oral - | 90 mg capsule | ![]() | |
fenofibrate micronized oral - | 67 mg capsule | ![]() | |
fenofibrate micronized oral - | 200 mg capsule | ![]() | |
fenofibrate micronized oral - | 134 mg capsule | ![]() | |
fenofibrate micronized oral - | 134 mg capsule | ![]() | |
fenofibrate micronized oral - | 134 mg capsule | ![]() | |
fenofibrate micronized oral - | 130 mg capsule | ![]() | |
fenofibrate micronized oral - | 43 mg capsule | ![]() | |
fenofibrate micronized oral - | 134 mg capsule | ![]() | |
fenofibrate micronized oral - | 134 mg capsule | ![]() | |
fenofibrate micronized oral - | 43 mg capsule | ![]() | |
fenofibrate micronized oral - | 67 mg capsule | ![]() | |
fenofibrate micronized oral - | 200 mg capsule | ![]() | |
fenofibrate micronized oral - | 200 mg capsule | ![]() | |
fenofibrate micronized oral - | 67 mg capsule | ![]() | |
fenofibrate micronized oral - | 200 mg capsule | ![]() | |
fenofibrate micronized oral - | 67 mg capsule | ![]() | |
fenofibrate micronized oral - | 134 mg capsule | ![]() | |
fenofibrate micronized oral - | 134 mg capsule | ![]() | |
fenofibrate micronized oral - | 200 mg capsule | ![]() | |
fenofibrate micronized oral - | 134 mg capsule | ![]() | |
fenofibrate micronized oral - | 67 mg capsule | ![]() | |
fenofibrate micronized oral - | 200 mg capsule | ![]() | |
fenofibrate micronized oral - | 67 mg capsule | ![]() | |
fenofibrate micronized oral - | 200 mg capsule | ![]() | |
fenofibrate micronized oral - | 130 mg capsule | ![]() | |
fenofibrate micronized oral - | 134 mg capsule | ![]() | |
fenofibrate micronized oral - | 200 mg capsule | ![]() | |
fenofibrate micronized oral - | 67 mg capsule | ![]() | |
fenofibrate micronized oral - | 67 mg capsule | ![]() |
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