fenofibrate

Fenofibrate is a medication used to modulate the levels of fatty substances (lipids) in the blood. Fenofibrate, used in addition to a low-fat diet, reduces blood levels of triglycerides and the types of cholesterol that increase the risk for plaque buildup in arteries (atherosclerosis), and increases the type of cholesterol that is beneficial to health. 

• Triglycerides and cholesterol are synthesized in the liver and also absorbed from our dietary intake. While lipids are essential for many functions in the body, excess levels can clog up blood vessels and increase the risk for heart disease, stroke and other diseases. Following are the main types of lipids in the body:
• Triglycerides: The most common form of fat that the body uses as fuel for energy and to store extra energy.
• Cholesterol: A waxy combination of lipid and protein (lipoprotein) that the body uses to build cell membranes, produce hormones, bile acids and vitamin D.
• LDL cholesterol: Low density lipoprotein (LDL) carries cholesterol to cells all over the body.
• VLDL cholesterol: Very low density lipoprotein (LDL) is made by the liver to transport triglycerides to the cells; VLDL turns into LDL after delivering triglycerides to the cells.
• HDL cholesterol: High density lipoprotein (HDL) absorbs cholesterol from the cells and transports it back to the liver to be converted into bile acids which aid digestion of dietary fat and get excreted.

Fenofibrate reduces the levels of triglycerides, total cholesterol, LDL and VLDL cholesterol, and increases HDL cholesterol levels. Fenofibrate works by activating peroxisome proliferator activated receptor-alpha (PPAR-A), a nuclear receptor protein in the liver. This results in:

• Activation of lipoprotein lipase, the enzyme that breaks down triglyceride-rich lipoproteins, leading to lower levels of triglycerides and apolipoprotein B, the protein component of LDL and VLDL cholesterol.
• Increase in the synthesis of HDL cholesterol and its major protein components apolipoproteins A-I and A-II.

Fenofibrate also reduces uric acid levels by increasing the excretion of uric acid in the urine. Fenofibrate is used to treat:

• High total blood cholesterol levels (hypercholesterolemia)
• High blood triglyceride levels (hypertriglyceridemia)
• High triglyceride levels and low HDL cholesterol (mixed dyslipidemia)

• Do not administer fenofibrate to patients with hypersensitivity to fenofibrate or any of its components
• Do not administer fenofibrate to patients with:
  • Severe kidney impairment
  • Gallbladder disease
  • Active liver disease
  • Nursing mothers
• Fenofibrate at a dose equivalent to 145 mg of Tricor was not seen to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus
• Fenofibrate increases risk for muscle disease and muscle breakdown (rhabdomyolysis); monitor creatine phosphokinase levels
• Discontinue if liver enzymes persist at 3 times above the upper normal limit
• Discontinue use if symptoms of gallstones develop
• Increases serum creatinine levels; monitor kidney function in patients at risk for kidney damage
• Decrease in platelets and immune cells (granulocytes) may occur; monitor blood count periodically in the first year of therapy
• Use with caution in patients on oral anticoagulants and adjust doses appropriately
• May increase the risk for pulmonary embolism and deep vein thrombosis (DVT); use with caution in patients with risk factors for venous thromboembolism
• May cause paradoxical drop in HDL cholesterol levels

Common side effects of fenofibrate include:

• Abnormal liver function tests
• Increase in liver enzymes ALT and AST
• Increase in creatine phosphokinase (CPK)
• Respiratory disorder
• Abdominal pain
• Headache
• Back pain
• Nausea
• Constipation
• Nasal inflammation (rhinitis)

Less common side effects of fenofibrate include:

• Flatulence
• Diarrhea
• Peptic ulcer
• Inflammation of the pancreas (pancreatitis)
• Gallstones (cholelithiasis)
• Liver inflammation (hepatitis)
• Liver cirrhosis
• Muscle inflammation (myositis)
• Muscle diseases (myopathies)
• Joint pain (arthralgia)
• Weakness (asthenia)
• Rash and skin peeling
• Irregular heart rhythms (dysrhythmias)
• Peripheral vascular disease
• Blood clot or plaque in the lung (pulmonary embolism)
• Depression of central nervous system (CNS)
• Kidney damage or failure
• Low red cell count (anemia)
• Low white cell count (leukopenia)
• Decrease in hemoglobin
• Decrease in hematocrit
• Reduced HDL cholesterol level
• Interstitial lung disease

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug.

Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

TriCor tablet

• 48mg
• 145mg

Lofibra tablet

• 54mg
• 160mg

Fenoglide tablet

• 40mg
• 120mg

Triglide tablet

• 160mg

Lipofen capsule

• 50mg
• 150mg

Adult:

TriCor

• Hypercholesterolemia, mixed dyslipidemia: Initially, 145 mg orally once a day
• Hypertriglyceridemia: Initially, 48-145 mg orally once a day
• Titrate q4-8 week up to no more than 145 mg orally once a day

Triglide

• Hypercholesterolemia, Mixed Dyslipidemia: initial 160 mg orally once a day
• Hypertriglyceridemia: 50-160 mg orally once a day initially

Lipofen

• Hypercholesterolemia, Mixed Dyslipidemia: initial 150 mg orally once a day
• Hypertriglyceridemia: initial 50-150 mg orally once a day

Lofibra tablets

• Hypercholesterolemia, Mixed Dyslipidemia: 160 mg orally once a day
• Hypertriglyceridemia: 54-160 mg orally once a day

Fenoglide

• Hypercholesterolemia, Mixed Dyslipidemia: 120 mg orally once a day
• Hypertriglyceridemia: 40-120 mg orally once a day

Dosing Modifications

Renal impairment

• TriCor (CrCl <50 mL/min): 48 mg/day initially; evaluate before increase dose
• Triglide: Initial, 50 mg/day
• Lipofen: Initial, no more than 50 mg/day
• Lofibra tablets: Initial, 54 mg/day
• Fenoglide: Initial, 40 mg/day

Dosing Considerations

• Rule out secondary causes of hyperlipidemia before initiating therapy
• Withdraw therapy if no adequate response seen after 2-3 months
• Use with caution in the elderly; dose adjustments may be necessary

Administration

• TriCor, Triglide, and Lofibra tablets can be taken without regard to meals
• Lipofen: Take with meals

Geriatric:

TriCor

• Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia
• Initial: 48 mg/day; evaluate before increase dose

Triglide

• Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia
• Initial: 50 mg/day

Lipofen

• Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia
• Initial: No more than 50 mg/day

Lofibra tablets

• Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia
• Initial: 54 mg/day

Fenoglide

• Hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia
• Initial: 40 mg/day

Pediatric:

• Safety and efficacy not established

• Symptoms of fenofibrate overdose include gastrointestinal distress.
• There is no specific treatment for overdose, treatment is supportive and symptomatic.
• If indicated, unabsorbed drugs may be removed from the stomach by induced vomiting or gastric lavage.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Fenofibrate has no known severe interactions with other drugs.
• Serious Interactions of fenofibrate include:
  • abametapir
  • apalutamide
  • atorvastatin
  • colchicine
  • fexinidazole
  • fluvastatin
  • pravastatin
  • rosuvastatin
  • simvastatin
  • tucatinib
• Fenofibrate has moderate interactions with at least 37 different drugs.
• Mild Interactions of fenofibrate include:
  • colestipol
  • ezetimibe
  • levoketoconazole
  • octacosanol
  • ribociclib

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There is insufficient data on fenofibrate use in pregnancy to determine risk of miscarriage, maternal risks or fetal harm; use only if potential benefit justifies potential risk to fetus.
• There is no information on the presence of fenofibrate in human milk, and its effects on the breastfed infant or on milk production. Fenofibrate is present in milk of rats, and likely to be present in human milk. Breastfeeding women should avoid use because of the potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism.

For fenofibrate therapy to be effective in maintaining optimal lipid levels, it is also important to:

• Eat low fat, low cholesterol diet
• Maintain healthy weight
• Exercise regularly
• Avoid smoking