Fenofibrate

What is Fenofibrate?

• Fenofibrate (Tricor, Fenobrat etc.) is a peroxisome proliferator receptor alpha (PPARα) activator used in the therapy of hypertriglyceridemia and dyslipidemia.

Fenofibrate structure

Fenofibrate molecule ball

Fenofibrate molecule spacefill

What are the uses of this medicine?

Fenofibrate (Tricor, Fenobrat etc.) is used as adjunctive therapy to diet:

• to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
• for treatment of adult patients with severe hypertriglyceridemia.

Limitations of use:

• Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.

How does this medicine work?

• Fenofibrate (fen" oh fye' brate) is a fibric acid derivative.
• The active moiety of fenofibrate is fenofibric acid.
• Its lipid lowering activity is probably mediated by its interactions with the peroxisome proliferator activated receptor alpha (PPARα), which regulates gene expression of enzymes involved in fatty acid oxidation.
• These fenofibrate induced changes cause an increase in lipoprotein lipase levels which enhance clearance of triglyceride-rich lipoproteins.
• Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• severe renal impairment, including those receiving dialysis
• active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities
• pre-existing gallbladder disease
• nursing mothers
• known hypersensitivity to fenofibric acid or fenofibrate

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin)
• colchicine (Colcrys, in Col-Probenecid)
• diuretics ('water pills')
• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• HMG-CoA reductase inhibitors (cholesterol-lowering agents) such as atorvastatin (Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• hormone replacement therapy
• hormonal contraceptives (birth control pills, patches, implants, rings, and injections)
• immunosuppressants such as cyclosporine (Sandimmune, Neoral) and tacrolimus (Prograf)

• If you are taking a bile acid resin such as cholestyramine (Questran), colesevelam (WelChol), or colestipol (Colestid), take it 1 hour after or 4-6 hours before you take fenofibrate.

Is this medicine FDA approved?

• Fenofibrate was approved for use in Europe in 1975 and in the United States in 1993.

How should this medicine be used?

Recommended dosage: Primary Hypercholesterolemia and Mixed Dyslipidemia:

• The initial dose of fenofibrate capsules is 130 mg per day.

Severe Hypertriglyceridemia:

• The initial dose is 43 to 130 mg per day.
• Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.
• The maximum dose is 130 mg per day.

Impaired Renal Function:

• Treatment with fenofibrate capsules should be initiated at a dose of 43 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation.

Administration:

• Fenofibrate comes as a capsule, a delayed-release (long-acting) capsule, and a tablet to take by mouth.
• It is usually taken once a day.
• Some fenofibrate products (Fenoglide, Lipofen, and Lofibra) should be taken with a meal.
• Other brands (Antara, Fibricor, Tricor, Triglide, and Trilipix) may be taken with or without food.
• Patients should be advised to swallow fenofibrate capsules whole.
• Do not open, crush, dissolve or chew capsules.
• If you are taking Triglide tablets, do not use any tablets that are chipped or broken.
• Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.
• Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 130 mg once daily.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a capsule, a delayed-release (long-acting) capsule, and a tablet

This medicine is available in fallowing brand namesː

• Antara
• Fenoglide
• Lipidil
• Lipofen
• TriCor
• Triglide
• Trilipix

What side effects can this medication cause?

The most common side effects of this medicine include:

• abnormal liver tests, increased AST, increased ALT, increased CPK
• rhinitis
• Abdominal Pain
• Back Pain
• Headache
• Nausea
• Constipation
• Respiratory Disorder
• Rhinitis

Less common, but serious side effects may include:

• Mortality and coronary heart disease morbidity
• Hepatoxicity
• Pancreatitis
• Hypersensitivity reactions
• Venothromboembolic disease

What special precautions should I follow?

• Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibrate. Monitor patient’s liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy. Discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist.
• Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risk for serious muscle toxicity appears to be increased when fenofibrate is co-administered with a statin (with a significantly higher rate observed with gemfibrozil), particularly in elderly patients and in patients with diabetes, renal failure, or hypothyroidism
• Fenofibrate can reversibly increase serum creatinine levels. Monitor renal function periodically in patients with renal impairment.
• Fenofibrate increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated.
• Exercise caution in concomitant treatment with coumarin anticoagulants. Reduce the dosage of coumarin to maintain the PT/INR at the desired level to prevent bleeding complications.
• Acute hypersensitivity reactions, including anaphylaxis and angioedema, and delayed hypersensitivity reactions, including severe cutaneous adverse drug reactions have been reported postmarketing. Some cases were life-threatening and required emergency treatment. Discontinue fenofibrate and treat patients appropriately if reactions occur.
• Fenofibrate should not be used in nursing mothers. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
• Tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had diabetes or hypothyroidism (underactive thyroid gland).
• Fenofibrate therapy is associated with mild and transient serum aminotransferase elevations and with rare instances of acute liver injury, which can be severe and prolonged and lead to significant hepatic fibrosis.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• There is no specific treatment for overdose with fenofibrate.
• General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur.
• If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway.
• Because fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• Safety in pregnant women has not been established.
• There are no adequate and well controlled studies of fenofibrate in pregnant women.
• Fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• FENOFIBRATE

Inactive ingredients:

• SILICON DIOXIDE
• CROSPOVIDONE
• SODIUM LAURYL SULFATE
• GELATIN, UNSPECIFIED
• TITANIUM DIOXIDE
• D&C YELLOW NO. 10
• FD&C BLUE NO. 2
• SHELLAC
• FERROSOFERRIC OXIDE
• PROPYLENE GLYCOL
• AMMONIA

Who manufactures and distributes this medicine?

Fenofibrate capsules:

• APOTEX INC.

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Lipid lowering medications

• Bile Acid Resins/Sequestrants

• • Cholestyramine
  • Colesevelam
  • Colestipol

• Fibrates
  • Clofibrate
  • Fenofibrate
  • Gemfibrozil

• Monoclonal Antibodies - Anti-PCSK9
  • Alirocumab
  • Evolocumab

• Niacin (Nicotinic Acid)

• • Omega-3 Fatty Acids,
  • Icosapent Ethyl
  • Omega-3 Acid Ethyl Esters
  • Omega-3 Carboxylic Acids

• Statins
  • Atorvastatin
  • Fluvastatin
  • Lovastatin
  • Pitavastatin
  • Pravastatin
  • Rosuvastatin
  • Simvastatin

• Miscellaneous
  • Ezetimibe
  • Lomitapide
  • Mipomersen

• Dailymed label info on Fenofibrate
• FDA Fenofibrate

Fenofibrate Resources
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