Pegylated interferon alfa-2a indications and usage

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. [1]

Indications And Usage

Chronic hepatitis C

PEGASYS, peginterferon alfa-2a, alone or in combination with COPEGUS, is indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection with compensated liver disease and have not been previously treated with interferon alpha. Efficacy has been demonstrated in subjects with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and in adult subjects with clinically stable HIV disease and CD4 count greater than 100 cells/mm3.

Pegasys in combination with Copegus and an approved hepatitis C Virus (HCV) NS3/4A protease inhibitor is indicated in adult patients (18 years of age and older) with HCV genotype 1 infection (see the Package Insert of the specific HCV NS3/4A protease inhibitor for further information). Pegasys in combination with Copegus is indicated in patients with HCV genotypes other than 1, pediatric patients (5-17 years of age), or in patients with HCV genotype 1 infection where use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications or other clinical factors.

The following points should be considered when initiating therapy with PEGASYS and COPEGUS:

Use of PEGASYS monotherapy is not recommended for treatment of CHC unless a patient has a contraindication to or significant intolerance to ribavirin. Combination therapy provides substantially better response rates than monotherapy [see Clinical Studies (14)]. Safety and efficacy have not been demonstrated for treatment longer than 48 weeks. The safety and efficacy have not been established in liver or other organ transplant recipients [see Use in Specific Populations (8.7)].

Chronic hepatitis B

PEGASYS is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation.

References

Adapted from the FDA Package Insert.