Pegasys

PEGASYS- peginterferon alfa-2a injection, solution
pharmaand GmbH

WARNING: RISK OF SERIOUS DISORDERS

Risk of Serious Disorders

Alpha interferons, including PEGASYS (peginterferon alfa-2a), may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy [see Warnings and Precautions (5.2, 5.5, 5.8, 5.11, 5.14, 5.16), Adverse Reactions (6.1)and Nonclinical Toxicology (13.1)] .

1 INDICATIONS AND USAGE

1.1 Chronic Hepatitis C (CHC)

Adult Patients:PEGASYS, as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is indicated for the treatment of adults with CHC and compensated liver disease. For information about the safe and effective use of other HCV antiviral drugs to be used in combination with PEGASYS, refer to their prescribing information. PEGASYS monotherapy is only indicated for the treatment of patients with CHC and compensated liver disease if there are contraindications or significant intolerance to other HCV antiviral drugs.

Pediatric Patients:PEGASYS in combination with ribavirin is indicated for the treatment of pediatric patients 5 years of age and older with CHC and compensated liver disease.

Limitations of Use:

  • PEGASYS alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa.
  • PEGASYS is not recommended for treatment of patients with CHC who have had solid organ transplantation [see Use in Specific Populations (8.8)] .

1.2 Chronic Hepatitis B (CHB)

Adult Patients:PEGASYS is indicated for the treatment of adults with HBeAg-positive and HBeAg-negative CHB infection who have compensated liver disease and evidence of viral replication and liver inflammation.

Pediatric Patients:PEGASYS is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic pediatric patients 3 years of age and older with evidence of viral replication and elevations in serum alanine aminotransferase (ALT).

2 DOSAGE AND ADMINISTRATION

2.1 Dosage Overview

Administer PEGASYS by subcutaneous injection once weekly in the abdomen or thigh for the treatment of:

For treatment of CHC, use PEGASYS in combination with other HCV antiviral drugs. For information about the recommended dosage and administration and the safe and effective use of these other HCV antiviral drugs, refer to their prescribing information. PEGASYS monotherapy is only indicated in the treatment of CHC if there are contraindications to or significant intolerance to other HCV antiviral drugs.

For dosage modifications in patients with CHC or CHB:

For important administration instructions for all the PEGASYS injection presentations (i.e., vial and prefilled syringe) [ see Dosage and Administration (2.7)].

2.2 Recommended Dosage for Adults with CHC

Dosage in Adults with CHC without HIV Coinfection

Table 1 displays the recommended dosage and duration of PEGASYS and other HCV antiviral drugs in adults with CHC (without HIV coinfection) based on HCV genotype.

For treatment of HCV genotype 1 with PEGASYS in combination with ribavirin or alone, discontinuation of treatment is recommended if at least a 2 log 10 reduction from baseline in HCV RNA has not been demonstrated by 12 weeks of therapy or if undetectable HCV RNA has not been achieved after 24 weeks of therapy [see Clinical Studies (14)] . Refer to the prescribing information for specific HCV antiviral drugs used in combination with PEGASYS for information on stopping therapy based on treatment response.

Immediately discontinue PEGASYS for hepatic decompensation (Child-Pugh score greater than 6 [class B and C]).

Table 1 Recommended Dosage for PEGASYS for Adults with CHC Infection *
Hepatitis C Virus Genotype PEGASYS Dosage PEGASYS Duration
*
If PEGASYS is used in combination with other antiviral drugs for CHC, refer to the prescribing information of the other HCV antiviral drugs for the recommended dosage of the other HCV antiviral drugs and duration of the entire treatment regimen.
If PEGASYS and ribavirin are used without other HCV antiviral drugs the recommended duration of therapy is 48 weeks.
If PEGASYS and ribavirin are used without other HCV antiviral drugs the recommended duration of therapy is 24 weeks.

Genotypes 1, 4

180 mcg subcutaneous injection in thigh or abdomen once weekly

Refer to the prescribing information of HCV antiviral drugs.

Genotypes 2, 3

Genotypes 5, 6

There are insufficient data for dosage recommendations

If PEGASYS monotherapy is used for treatment of CHC, the recommended PEGASYS dosage is 180 mcg via subcutaneous injection in thigh or abdomen once weekly for 48 weeks.

Dosage in Adults with CHC with HIV Coinfection

The recommended PEGASYS dosage in adults with CHC and HIV coinfection is 180 mcg subcutaneously once weekly in the thigh or abdomen. If PEGASYS is used in combination with other antiviral drugs, refer to the prescribing information of the other HCV antiviral drugs for the recommended dosage of the other HCV antiviral drugs and duration of the entire treatment regimen (including PEGASYS). If PEGASYS and ribavirin are used without other HCV antiviral drugs, the recommended duration of therapy is 48 weeks (regardless of HCV genotype).

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.