Fenofibric acid

What is Fenofibric acid?

• Fenofibric acid (Trilipix; fibricor) a peroxisome proliferator-activated receptor (PPAR) alpha agonist used to treat cholesterol in the blood by lowering the total amount of triglycerides and LDL (bad) cholesterol, and increasing the HDL (good) cholesterol.

Choline fenofibrate

What are the uses of this medicine?

Fenofibric acid (Trilipix; fibricor) as adjunctive therapy to diet to:

• Reduce TG in patients with severe hypertriglyceridemia.
• Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDLC in patients with primary hypercholesterolemia or mixed dyslipidemia.

Limitations of use:

• Fenofibric acid have not been shown to lower your risk of having heart problems or a stroke.
• You should be on a low fat and low cholesterol diet while you take fenofibric acid capsules.

How does this medicine work?

• The active moiety of fenofibric acid delayed-release capsule is fenofibric acid.
• Fenofibric acid increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of Apo CIII (an inhibitor of lipoprotein lipase activity).
• Activation of PPARα also induces an increase in the synthesis of HDL-C and Apo AI and AII.

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.
• preexisting gallbladder disease
• nursing mothers
• hypersensitivity to fenofibric acid or fenofibrate

What drug interactions can this medicine cause?

• Using fenofibric acid delayed-release capsules with certain other medicines can affect the way these medicines work and other medicines may affect how fenofibric acid delayed-release capsules works. In some cases, using fenofibric acid delayed-release capsules with other medicines can cause serious side effects.

It is especially important to tell your healthcare provider if you take any of the medicines listed below:

• anticoagulants, also known as blood thinners (warfarin, Coumadin)
• bile acid resins
• cyclosporine

Is this medicine FDA approved?

• Initial U.S. Approval: 2008

How should this medicine be used?

Recommended dosage: Severe Hypertriglyceridemia:

• The initial dose of fenofibric acid delayed-release capsules is 45 to 135 mg once daily.
• 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 135 mg once daily.

Primary Hypercholesterolemia or Mixed Dyslipidemia:

• The dose of fenofibric acid delayed-release capsule is 135 mg once daily.

Renally impaired patients:

• 45 mg once daily

fenofibric acid tablet (fibricor) dosage:

• Severe hypertriglyceridemia: 35 to 105 mg/day; the dose should be adjusted according to patient response.
• Primary hypercholesterolemia or mixed dyslipidemia: 105 mg/day.
• Renally impaired patients: Initial dose of 35 mg once daily.
• Geriatric patients: Select the dose on the basis of renal function

Administration:

• May be taken without regard to food.
• You should be on a low fat and low cholesterol diet while you take fenofibric acid capsules.
• Take fenofibric acid capsules one time each day as prescribed by your healthcare provider.
• Take fenofibric acid capsules with or without food.
• Swallow fenofibric acid capsules whole. Do not break, crush, dissolve, or chew fenofibric acid delayed-release capsules before swallowing. If you cannot swallow fenofibric acid delayed-release capsules whole, tell your healthcare provider, you may need a different medicine.
• If you miss a dose of fenofibric acid capsules, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. If you are not sure about your dosing, call your healthcare provider. Do not take more than one dose of fenofibric acid delayed-release capsules a day unless your healthcare provider tells you to.

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

This medicine is available in fallowing doasage form:

• As Oral Delayed Release Capsules: 45 mg and 135 mg
• Oral Tablets: 35 mg and 105 mg

This medicine is available in fallowing brand namesː

• Trilipix; fibricor

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• heartburn (indigestion)
• nausea
• muscle aches
• increases in muscle or liver enzymes that are measured by blood tests

Fenofibric acid may cause serious side effects, including:

• muscle pain, tenderness, or weakness
• tiredness and fever
• abdominal pain, nausea, or vomiting

What special precautions should I follow?

• Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risks for myopathy and rhabdomyolysis are increased in elderly patients; patients with diabetes, renal failure, or hypothyroidism; and patients being treated with a statin.
• Fenofibric acid delayed-release capsules can increase serum transaminases. Liver tests should be monitored periodically.
• Reversible elevations in serum creatinine have been reported in patients receiving fenofibric acid. Renal function should be monitored periodically in patients with renal insufficiency.
• Fenofibrate, clofibrate, and gemfibrozil, may increase cholesterol excretion into the bile, potentially leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated.
• Exercise caution in concomitant treatment with oral coumarin anticoagulants. Adjust the dosage of coumarin anticoagulant to maintain the prothrombin time/INR at the desired level to prevent bleeding complications.

What to do in case of emergency/overdose?

Management of overdosage:

• There is no specific treatment for overdose with fenofibric acid.
• 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 fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered.

Can this medicine be used in pregnancy?

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

Can this medicine be used in children?

• The safety and effectiveness of fenofibric acid in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: Fenofibric acid

• Inactive Ingredients: Hypromellose, povidone, water, hydroxylpropyl cellulose, colloidal silicon dioxide, sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, iron oxide yellow, and iron oxide red. The capsule shell of the 135 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, iron oxide yellow, and FD&C Blue #2. The capsule shells are printed with edible white ink and black ink. The edible white ink contains shellac, propylene glycol, potassium hydroxide, and titanium dioxide and the edible black ink contains shellac, propylene glycol, iron oxide black and, potassium hydroxide.

Who manufactures and distributes this medicine?

Fenofibric acid delayed-release capsules:

Manufactured by:

• Alembic Pharmaceuticals Limited
• (Formulation Division),
• Panelav, Gujarat, India

Manufactured for:

• Alembic Pharmaceuticals, Inc.
• Bridgewater, NJ
• USA

Fibricor Manufactured for:

• Athena Bioscience LLC
• Athens, GA

Trilipix:

• Manufactured for AbbVie Inc., North Chicago, IL 60064, U.S.A. by Fournier Laboratories Ireland Limited, Anngrove, Carrigtwohill Co. Cork, Ireland, or AbbVie LTD, Barceloneta, PR

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

• Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
• Keep out of the reach of children.
• Protect from moisture.

• Dailymed label info on Fenofibric acid
• FDA Fenofibric acid

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