Pegylated interferon alfa-2a

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Pegylated interferon alfa-2a
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: Gloria Picoy [2]

Disclaimer

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Pegylated interferon alfa-2a FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pegylated interferon alfa-2a in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pegylated interferon alfa-2a in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Pegylated interferon alfa-2a FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pegylated interferon alfa-2a in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pegylated interferon alfa-2a in pediatric patients.

Contraindications

There is limited information regarding Pegylated interferon alfa-2a Contraindications in the drug label.

Warnings

There is limited information regarding Pegylated interferon alfa-2a Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Pegylated interferon alfa-2a Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Pegylated interferon alfa-2a Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Pegylated interferon alfa-2a Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Pegylated interferon alfa-2a in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pegylated interferon alfa-2a in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pegylated interferon alfa-2a during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pegylated interferon alfa-2a in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Pegylated interferon alfa-2a in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Pegylated interferon alfa-2a in geriatric settings.

Gender

There is no FDA guidance on the use of Pegylated interferon alfa-2a with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pegylated interferon alfa-2a with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pegylated interferon alfa-2a in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pegylated interferon alfa-2a in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pegylated interferon alfa-2a in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pegylated interferon alfa-2a in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Pegylated interferon alfa-2a Administration in the drug label.

Monitoring

There is limited information regarding Pegylated interferon alfa-2a Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Pegylated interferon alfa-2a and IV administrations.

Overdosage

There is limited information regarding Pegylated interferon alfa-2a 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 Pegylated interferon alfa-2a Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Pegylated interferon alfa-2a Mechanism of Action in the drug label.

Structure

There is limited information regarding Pegylated interferon alfa-2a Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pegylated interferon alfa-2a Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Pegylated interferon alfa-2a Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Pegylated interferon alfa-2a Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Pegylated interferon alfa-2a Clinical Studies in the drug label.

How Supplied

There is limited information regarding Pegylated interferon alfa-2a How Supplied in the drug label.

Storage

There is limited information regarding Pegylated interferon alfa-2a 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 Pegylated interferon alfa-2a Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Pegylated interferon alfa-2a 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 Pegylated interferon alfa-2a Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Pegylated interferon alfa-2a Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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


Pegylated interferon alfa-2a
PEGASYS® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]

Overview

Pegylated interferon alfa-2a (40kD) (commercial name PEGASYS) is an antiviral drug discovered at the pharmaceutical company F.Hoffmann-La Roche; it has a dual mode of action - both antiviral and on the immune system.

This drug is approved around the world for the treatment of chronic hepatitis C (including patients with HIV co-infection, cirrhosis, 'normal' levels of ALT) and has recently been approved (in the EU, U.S., China and many other countries) for the treatment of chronic hepatitis B.

Category

Antiviral

US Brand Names

Pegasys®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages

Mechanism of Action

References