Generic Name: Fenofibrate Brand Name(s): Fenofibrate.

Uses

What is Fenofibrate used for?

Fenofibrate is commonly 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 this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

How should I take Fenofibrate?

Take this medication by mouth as directed by your doctor, usually once daily. Fenofibrate comes in different types of capsules and tablets which provide different amounts of the medication. Do not switch between different forms or brands of this medication unless directed by your doctor. Some forms of this drug should be taken with food but others may be taken with or without food. Ask your pharmacist about your brand of fenofibrate. It is important to take this medication correctly so that the drug has the greatest benefit.

The dosage is based on your medical condition and response to treatment.

If you are also taking certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take fenofibrate at least 1 hour before or at least 4 to 6 hours after taking these medications. These medications can bind to fenofibrate, preventing your body from fully absorbing the drug.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your cholesterol/triglycerides level will not lower faster, and your risk of side effects will increase. It is important to continue taking this medication even if you feel well. Most people with high cholesterol/triglycerides do not feel sick.

It is very important to continue to follow your doctor’s advice about diet and exercise. It may take up to 2 months before you get the full benefit of this medication.

How do I store Fenofibrate?

Fenofibrate is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Fenofibrate in the bathroom or the freezer. There may be different brands of Fenofibrate that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Fenofibrate down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Fenofibrate?

Before taking fenofibrate, tell your doctor or pharmacist if you are allergic to it; or to other “fibrates” (such as fenofibric acid); or if you have any other allergies. This product may contain inactive ingredients (such as soy), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, gallbladder disease, liver disease (such as biliary cirrhosis, hepatitis), alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Fenofibrate during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Fenofibrate. Fenofibrate is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Fenofibrate?

This medication may rarely cause gallstones and liver problems. If you notice any of the following unlikely but seriouspersistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

This drug may rarely cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine).

Rarely, this medication has caused severe lowering of HDL (“good” cholesterol) levels. This is the opposite of what should happen to your HDL levels (paradoxical reaction). Your HDL cholesterol levels should be checked regularly. Keep all of your laboratory appointments.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), unusual tiredness.

Get medical help right away if you have any very serious side effects, including: chest pain, sudden pain/redness/swelling usually in the leg.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Fenofibrate?

Some products that may interact with this drug include: “blood thinners” (such as warfarin).

Fenofibrate is very similar to fenofibric acid. Do not use medications containing fenofibric acid while using fenofibrate.

Fenofibrate may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Fenofibrate?

Fenofibrate may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Fenofibrate?

Fenofibrate may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Fenofibrate.

What is the dose of Fenofibrate for an adult?

Usual Adult Dose for Hyperlipidemia

Capsules: 150 mg orally once a day

Micronized Capsules: 90 to 200 mg orally once a day

Tablets: 120 to 160 mg orally once a day

Comments:

-Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose.

Use: As an adjunct 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 patients with primary hyperlipidemia or mixed dyslipidemia (Fredrickson Types IIa and IIb)

Usual Adult Dose for Hyperlipoproteinemia Type IIa (Elevated LDL)

Capsules: 150 mg orally once a day

Micronized Capsules: 90 to 200 mg orally once a day

Tablets: 120 to 160 mg orally once a day

Comments:

-Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose.

Use: As an adjunct 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 patients with primary hyperlipidemia or mixed dyslipidemia (Fredrickson Types IIa and IIb)

Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL)

Capsules: 150 mg orally once a day

Micronized Capsules: 90 to 200 mg orally once a day

Tablets: 120 to 160 mg orally once a day

Comments:

-Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose.

Use: As an adjunct 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 patients with primary hyperlipidemia or mixed dyslipidemia (Fredrickson Types IIa and IIb)

Usual Adult Dose for Dyslipidemia

Capsules: 150 mg orally once a day

Micronized Capsules: 90 to 200 mg orally once a day

Tablets: 120 to 160 mg orally once a day

Comments:

-Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose.

Use: As an adjunct 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 patients with primary hyperlipidemia or mixed dyslipidemia (Fredrickson Types IIa and IIb)

Usual Adult Dose for Hyperlipoproteinemia Type IV (Elevated VLDL)

Capsules:

-Initial dose: 50 to 150 mg orally per day

-Maximum dose: 150 mg once a day

Micronized Capsules:

-Initial dose: 30 to 200 mg orally per day

-Maximum dose: 90 to 200 mg/day

Tablets:

-Initial dose: 40 to 160 mg orally per day

-Maximum dose: 120 to 160 mg/day

Comments:

-Dosages should be individualized according to patient response and adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.

-Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose.

Use: As an adjunct to diet for the treatment of severe hypertriglyceridemia (Fredrickson Types IV and V)

Usual Adult Dose for Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL)

Capsules:

-Initial dose: 50 to 150 mg orally per day

-Maximum dose: 150 mg once a day

Micronized Capsules:

-Initial dose: 30 to 200 mg orally per day

-Maximum dose: 90 to 200 mg/day

Tablets:

-Initial dose: 40 to 160 mg orally per day

-Maximum dose: 120 to 160 mg/day

Comments:

-Dosages should be individualized according to patient response and adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.

-Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose.

Use: As an adjunct to diet for the treatment of severe hypertriglyceridemia (Fredrickson Types IV and V)

Usual Adult Dose for Hypertriglyceridemia

Capsules:

-Initial dose: 50 to 150 mg orally per day

-Maximum dose: 150 mg once a day

Micronized Capsules:

-Initial dose: 30 to 200 mg orally per day

-Maximum dose: 90 to 200 mg/day

Tablets:

-Initial dose: 40 to 160 mg orally per day

-Maximum dose: 120 to 160 mg/day

Comments:

-Dosages should be individualized according to patient response and adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.

-Therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment with the maximum recommended dose.

Use: As an adjunct to diet for the treatment of severe hypertriglyceridemia (Fredrickson Types IV and V)

Renal Dose Adjustments

Mild to moderate renal dysfunction:

-Capsules: 50 mg orally once a day

-Micronized Capsules: 30 to 67 mg orally once a day

-Tablets: 40 to 54 mg orally once a day; Triglide(R): Not recommended.

Comments:

-Doses may be increased after evaluation of the effects on renal function and lipid levels at the initial dose chosen.

Severe renal dysfunction: Contraindicated

Liver Dose Adjustments

Active liver disease (including primary biliary cirrhosis and unexplained persistent liver function abnormalities): Contraindicated

Dose Adjustments

Elderly: Due to the higher incidence of renal impairment in this patient population, dose selection should be based on renal function; monitor renal function during therapy; Lofibra(R) micronized capsules should be initiated and limited to 67 mg/day

Dialysis

Contraindicated

Administration advice:

-May be taken with food to increase absorption.

-Swallow capsules and tablets whole; do not break, open, crush, dissolve, or chew.

-Take at least 1 hour before or 4 to 6 hours after a bile acid binding resin.

Storage requirements:

-Protect from light and moisture.

-Triglide(R): Dispense in original bottle.

General:

-Patients should be placed on an appropriate lipid-lowering diet prior to receiving this drug and should continue this diet throughout treatment.

-This drug has not been shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.

-Markedly elevated levels of serum TG (e.g. greater than 2000 mg/dL) may increase the risk of developing pancreatitis; the effect of this drug on reducing this risk has not been adequately studied.

-An attempt should be made to control serum lipids with non-pharmacologic methods prior to initiating drug therapy (e.g., diet, exercise, control of medical problems, dose reduction of medications known to exacerbate hypertriglyceridemia, etc.).

Monitoring:

-Hematologic: Monitor RBC and WBC counts periodically during the first 12 months of therapy.

-Hepatic: Measure liver function at baseline and periodically thought-out therapy.

-Metabolic: Periodically measure lipid levels and adjust dose accordingly.

-Renal: Monitor renal function in patients with renal impairment or those at risk for renal insufficiency.

Patient advice:

-Report immediately any muscle pain, tenderness, or weakness, onset of abdominal pain, or any other new symptoms.

-Talk to your health care provider if you are pregnant, planning to become pregnant, or breastfeeding.

What is the dose of Fenofibrate for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Fenofibrate available?

Fenofibrate is available in the following dosage forms and strengths:

  • Oral Tablet
  • Oral Capsule

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Fenofibrate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 30, 2018 | Last Modified: January 30, 2018

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