fenofibric acid (Rx)

Brand and Other Names:Fibricor, Trilipix
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Dosing & Uses


Dosage Forms & Strengths

tablet (Fibricor)

  • 35mg
  • 105mg

capsule, delayed-release (Trilipix)

  • 45mg
  • 135mg


Indicated as adjunct to diet for severe hypertriglyceridemia (>500 mg/dL)

Fibricor: 35-105 mg PO qDay

Trilipix: 45-135 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

Fibricor: 105 mg PO qDay

Trilipix: 135 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

Indication for use with statins withdrawn by FDA

  • April 15, 2016: Based on several large cardiovascular outcome trials including AIM-HIGH, ACCORD, and HPS2-THRIVE, the FDA decided that "scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events"
  • Consistent with this conclusion, the FDA has determined that the benefits of fenofibric-acid (delayed-release) capsules (eg, Trilipix) for coadministration with statins no longer outweigh the risks, and the approval for this indication should be withdrawn

Safety and efficacy not established



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            Adverse Effects


            Headache (11.9-13.1%)


            Back pain (4.1-6.3%)

            Nausea (3.5-5.5%)

            Upper respiratory tract infection (3.7-5.3%)

            Nasopharyngitis (3.5-4.7%)

            Diarrhea (3.1-3.7%)

            Myalgia (3.1-3.5%)

            Increased AST (3.4%)

            Increased ALT (3%)

            Increased CPK (3%)

            Postmarketing Reports

            Myalgia, rhabdomyolysis, muscle spasms, arthralgia


            Renal failure

            Hepatitis, cirrhosis


            Severely depressed HDL levels

            Photosensitivity reactions (may occur days to months after initiating therapy)

            Interstitial lung disease

            Increase total bilirubin


            Decreases in hematocrit

            White blood cell decreases





            Severe renal impairment (including dialysis)

            Active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities

            Pre-existing gallbladder disease

            Breastfeeding women


            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

            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

            Acute hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic necrolysis) reported PE and DVT reported; use caution in patients with risk factors for VTE

            Severe cutaneous adverse drug reactions (SCAR), including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported postmarketing, occurring days to weeks after initiation of fenofibrate; 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

            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


            • 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


            Limited available data in pregnant women are insufficient to determine drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

            Animal data

            • In animal reproduction studies, no evidence of embryo-fetal toxicity observed with oral administration in rats and rabbits during organogenesis at doses less than or equivalent to maximum recommended clinical dose of 135 mg daily, based on body surface area (mg/m2); adverse reproductive outcomes occurred at higher doses in presence of maternal toxicity; therapy should be used during pregnancy only if potential benefit justifies potential risk to fetus


            There is no available information on presence of drug in human milk, effects on breastfed infant, or on milk production; drug is present in milk of rats, and is therefore likely to be present in human milk; because of potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment and for 5 days after final dose

            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.



            Mechanism of Action

            Fenofibric acid is the active metabolite of fenofibrate

            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


            Bioavailability: 81% (Trilipix)

            Peak Plasma Time: 4-5 hr (Trilipix); 2.5 hr (Fibricor)


            Time to steady-state: 8 days (Trilipix); 9 days (Fibricor)

            Protein Bound: 99%


            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


            Half-life: 20 hr

            Excretion: Primarily in urine as fenofibric acid and fenofibric acid glucuronide


            Genotyping patients with atherogenic dyslipidemia might establish who will benefit most from therapy with fenofibric to increase HDL-C





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            Tier Description
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