Fenofibrate

Class
Hypolipidemic agents
Subclass
PPARα agonists
Substance name
Fenofibrate, fenofibric acid
Brand names
Tricor®
Common formulations
Tablet, Capsule
Dosage and administration
Adults patients
Hypertriglyceridemia • Severe
•
Maintenance: 48-145 mg PO daily
•
Maximum: 145 mg per day
Titrate to response and adjust if necessary after repeat measurements at 4-8-week intervals.
Mixed hyperlipidemia
•
Maintenance: 145 mg PO daily
•
Maximum: 145 mg per day
Primary hypercholesterolemia
•
Maintenance: 145 mg PO daily
•
Maximum: 145 mg per day
Indications for use
Labeled indications
Adults
•
Treatment of hypertriglyceridemia (severe)
•
Treatment of mixed hyperlipidemia
•
Treatment of primary hypercholesterolemia
Safety risks
Contraindications
Hypersensitivity to fenofibrate or its components
Active liver disease
•
Do not use fenofibrate in patients with active liver disease, including primary biliary cirrhosis and unexplained persistent liver function abnormalities. Monitor LFTs at baseline and periodically during treatment. Discontinue fenofibrate if signs or symptoms of liver injury develop or if elevated enzyme levels persist.
Gallbladder disease
Warnings and precautions
Acute pancreatitis
•
Maintain a high level of suspicion, as fenofibrate has been associated with an increased risk of pancreatitis due to potential failure of efficacy in severe hypertriglyceridemia, medication side effects, or biliary tract stone or sludge formation leading to bile duct obstruction.
Bleeding
•
Use caution in patients taking coumarin anticoagulants. Monitor PT/INR and adjust anticoagulant dose as necessary.
Cardiovascular mortality
•
Maintain a high level of suspicion, as the effect of fenofibrate on coronary artery disease morbidity and mortality, as well as non-cardiovascular mortality, has not been established.
Cholelithiasis
•
Maintain a high level of suspicion, as fenofibrate increases cholesterol excretion and reduces bile acid excretion into bile, increasing the risk of cholelithiasis.
Decreased serum HDL
•
Maintain a high level of suspicion, as fenofibrate has been associated with a paradoxica reduction in serum HDL levels. Monitor HDL levels within the first few months of treatment.
Drug-induced liver injury
•
Maintain a high level of suspicion, as fenofibrate has been associated with an increased risk of serious drug-induced liver injury, including liver transplantation and death.
Hematologic abnormalities
•
Maintain a high level of suspicion, as fenofibrate has been associated with mild-to-moderate anemia, leukopenia, thrombocytopenia, and agranulocytosis. Monitor RBC and WBC counts during the first 12 month of treatment.
Increased serum creatinine
•
Maintain a high level of suspicion, as fenofibrate has been associated with elevated serum creatinine. Monitor renal function in patients with renal impairment, diabetes, and elderly patients.
Myopathy, rhabdomyolysis
•
Maintain a high level of suspicion, as fibrates are associated with an increased risk of myopathy and rhabdomyolysis, especially in elderly patients and in patients with diabetes, renal insufficiency, or hypothyroidism.
VTE
•
Maintain a high level of suspicion, as fenofibrate has been associated with an increased risk of PE and DVT.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Start at dose of 48 mg daily. Monitor renal function. Increase dose only after evaluation of the effects on renal function and lipid levels at this dose.
CrCl < 30 mL/min
•
Do not use.
Renal replacement therapy
Any modality
•
Do not use.
Hepatic impairment
Any severity
•
Do not use.
Unexplained abnormality in LFTs
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals.
Breastfeeding
Do not use during breastfeeding.
•
Advise females not to breastfeed for 5 days after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
↑ liver enzymes, ↑ serum CK, abdominal pain, back pain, constipation, headache, nausea, skin rash, rhinitis, urticaria
Unknown frequency
•
Pulmonary embolism, deep vein thrombosis, acute pancreatitis, cholelithiasis, drug-induced liver injury, acute kidney injury, liver cirrhosis, interstitial lung disease, asthenia, myalgia, arthralgia, ↑ serum creatinine, rhabdomyolysis, muscle spasms, ↑ serum TBIL, anemia, ↓ platelet count, ↓ WBC count, agranulocytosis, ↓ serum HDL, photosensitivity of skin
Interactions
Drug(s)
Check Interactions
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