Fenofibrate

Fenofibrate is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Fenofibrate belongs to a group of drugs known as "fibrates." Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibrate might not lower your risk of a heart attack or stroke. Talk to your doctor about the risks and benefits of fenofibrate.

In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help fenofibrate work better include

• exercising,
• losing weight if overweight, and
• stopping smoking.

Consult your doctor for more details.

• Fenofibrate is available under the following different brand names: Tricor, Lofibra tablets, Fenoglide, Lipofen, and Triglide.

Dosages of Fenofibrate:

Dosage Forms and Strengths

TriCor tablet

• 48 mg
• 145 mg

Lofibra tablet

• 54 mg
• 160 mg

Fenoglide tablet

• 40 mg
• 120 mg

Triglide tablet

• 160 mg

Lipofen capsule

• 50 mg
• 150 mg

Dosage Considerations – Should be Given as Follows:

Pediatric: Safety and efficacy not established

TriCor

• Hypercholesterolemia, mixed dyslipidemia: Initially, 145 mg orally once/day
• Hypertriglyceridemia: Initially, 48-145 mg orally once/day
• Titrate every 4-8 weeks up to no more than 145 mg orally once/day
• Geriatric, initial: 48 mg/day; evaluate before increase dose

Triglide

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

Lipofen

• Hypercholesterolemia, Mixed Dyslipidemia: initial 150 mg orally once/day
• Hypertriglyceridemia: initial 50-150 mg orally once/day
• Geriatric, initial: No more than 50 mg/day

Lofibra tablets

• Hypercholesterolemia, Mixed Dyslipidemia: 160 mg orally once/day
• Hypertriglyceridemia: 54-160 mg orally once/day
• Geriatric, initial: 54 mg/day

Fenoglide

• Hypercholesterolemia, Mixed Dyslipidemia: 120 mg orally once/day
• Hypertriglyceridemia: 40-120 mg orally once/day
• Geriatric, initial: 40 mg/day

Dosage Considerations

Overdose management

• Symptoms include GI distress
• Treatment is supportive

Dosing Modifications

Renal impairment (CrCl less than 50 mL/min):

• TriCor: Initial, 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

Administration

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

Side effects associated with the use of Fenofibrate, include the following:

• Increased liver function tests (LFT's) (dose-related)
• Respiratory disorder
• Abdominal pain
• Back pain
• CPK increased
• Headache
• Constipation
• Nausea
• Runny or stuffy nose

Postmarketing side effects of fenofibrate reported include:

• Muscle pain
• Muscle disease
• Muscle inflammation
• Diarrhea
• Gas (flatulence)
• Pancreatitis
• Peptic ulcer
• Cholelithiasis
• Central nervous system (CNS) depression
• Abnormal heart rhythms
• Peripheral vascular disease
• Blood clot in the lung (pulmonary embolus)
• Kidney damage
• Rash
• Anemia
• Low white blood cell count (leukopenia)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe interactions of fenofibrate include:
  • None
• Serious Interactions of fenofibrate include:
  • atorvastatin
  • colchicine
  • fluvastatin
  • idelalisib
  • ivacaftor
  • lovastatin
  • pitavastatin
  • pravastatin
  • rosuvastatin
  • simvastatin
  • warfarin
• Fenofibrate has moderate interactions with at least 26 different drugs.
• Mild Interactions of fenofibrate include:
  • colestipol
  • cyclosporine
  • ezetimibe
  • octacosanol

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

• This medication contains fenofibrate. Do not take Tricor, Lofibra tablets, Fenoglide, Lipofen, and Triglide if you are allergic to fenofibrate or any ingredients contained in this drug
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Known hypersensitivity
• Severe renal impairment, including those with end-stage renal disease and those receiving dialysis
• Active liver disease
• Gallbladder disease
• Nursing mothers

Effects of Drug Abuse

• No information provided

Short-Term Effects

• See "What Are Side Effects Associated with Using Fenofibrate?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Fenofibrate?”

Cautions

• Cholelithiasis reported with use; discontinue if gallstones detected upon gallbladder studies
• Rare myopathy, myositis, or rhabdomyolysis reported with use; monitor
• Increase in hepatic transaminases reported; discontinue if enzyme levels persist 3 times above the upper limit of normal
• Reversibly increases serum creatinine levels; consider monitoring renal function in patients at risk for renal impairment
• Thrombocytopenia and agranulocytosis reported; monitor blood counts periodically during the first year of therapy
• Associated with pulmonary embolism and deep venous thrombosis; use caution in patients with risk factors for venous thromboembolism (VTE)
• Concomitant use with oral anticoagulants (monitor and adjust warfarin dose as needed)
• May further increase the risk for rhabdomyolysis when added to optimal HMG-CoA reductase inhibitor regimen to further decrease triglycerides and increase HDLs
• Paradoxical decreases in HDL cholesterol (HDL-C) level reported
• 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
• Fenofibrate increases cholesterol excretion into the bile, leading to a risk of cholelithiasis; perform gallbladder studies if cholelithiasis suspected
• Fabric acid derivatives as monotherapy or in combination with simvastatin have not been shown to significantly reduce cardiovascular mortality in major clinical studies

Pregnancy and Lactation

• Use fenofibrate with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done
• It is unknown if fenofibrate is excreted in breast milk; it is not recommended for use while breastfeeding