Fenofibrate

Fenofibrate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2], Sheng Shi, M.D. [3]

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Overview

Fenofibrate is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of primary hypercholesterolemia or mixed dyslipidemia, severe hypertriglyceridemia. Common adverse reactions include abdomen pain, nausea, AST/SGOT level raised, liver function tests abnormal, backache, rhinitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

General Considerations (tablet)

• Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets can be given without regard to meals.
• The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.
• Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets 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• Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

General Considerations (capsule)

• Fenofibrate capsules should be given with meals thereby optimizing the absorption of the medication.
• Patients should be advised to swallow fenofibrate capsules whole. Do not open, crush, dissolve or chew capsules.
• Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules.
• The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.
• Periodic determination of serum lipids should be obtained during initial therapy in order to establish the lowest effective dose of fenofibrate. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 150 mg per day.
• Consideration should be given to reducing the dosage of fenofibrate if lipid levels fall significantly below the targeted range.

Primary Hypercholesterolemia or Mixed [[dyslipidemia]]

• Indication

• Fenofibrate tablets are indicated 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]].

• Dosing information (tablet)

• Initial dosage: 145 mg PO qd

• Dosing information (capsule)

• Initial dosage: 150 mg PO qd

Severe [[hypertriglyceridemia]]

• Indication

• Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
• Markedly elevated levels of serum triglycerides (e.g. >2000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

• Dosing information (tablet)

• Initial dosage: 48 -145 mg/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.
• Maximum dosage: 145 mg PO qd

• Dosing information (capsule)

• Initial dosage: 50-150 mg/day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determination at 4 to 8 week intervals.
• Maximum dosage: 150 mg PO qd

Impaired Renal Function

• Dosing information (tablet)

• In patients having mild to moderately impaired renal function:

• Initial dosage: 48 mg/day , and increased only after evaluation of the effects on renal function and lipid levels at this dose.

• The use of fenofibrate tablets should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

• Dosing information (capsule)

• In patients having mild to moderately impaired renal function:

• Initial dosage: 50 mg/day , and increased only after evaluation of the effects on renal function and lipid levels at this dose.

• The use of fenofibrate tablets should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Geriatric patients

• Dosing information

• Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Management of Hyperuricemia

• Developed by: American College of Rheumatology (ACR)

• Class of Recommendation: Not Applicable

• Level of Evidence: Level B

• Dosing Information

• Not Applicable

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Fenofibrate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

FDA Package Insert for Fenofibrate contains no information regarding FDA-labeled indications and dosage information for children.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Fenofibrate sandbox in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Fenofibrate sandbox in pediatric patients.

Contraindications

There is limited information regarding Fenofibrate Contraindications in the drug label.

Warnings

There is limited information regarding Fenofibrate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Fenofibrate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Fenofibrate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Fenofibrate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Fenofibrate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fenofibrate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fenofibrate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fenofibrate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Fenofibrate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Fenofibrate in geriatric settings.

Gender

There is no FDA guidance on the use of Fenofibrate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fenofibrate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fenofibrate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fenofibrate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fenofibrate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fenofibrate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Fenofibrate Administration in the drug label.

Monitoring

There is limited information regarding Fenofibrate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Fenofibrate and IV administrations.

Overdosage

There is limited information regarding Fenofibrate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Fenofibrate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Fenofibrate Mechanism of Action in the drug label.

Structure

There is limited information regarding Fenofibrate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Fenofibrate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Fenofibrate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Fenofibrate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Fenofibrate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Fenofibrate How Supplied in the drug label.

Storage

There is limited information regarding Fenofibrate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Fenofibrate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Fenofibrate sandbox interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Fenofibrate Brand Names in the drug label.

Look-Alike Drug Names

Tricor - Tracleer

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.