These highlights do not include all the information needed to use PEGASYS safely and effectively. See full prescribing information for PEGASYS.
PEGASYS® (peginterferon alfa-2a) injection, for subcutaneous use
Initial U.S. Approval: 2002
WARNING: RISK OF SERIOUS DISORDERS
See full prescribing information for complete boxed warning.
Risk of Serious Disorders
-
May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders (5)
RECENT MAJOR CHANGES
|
Boxed Warning |
9/2014 |
|
Indications and Usage (1) |
9/2014 |
|
Dosage and Administration (2) |
9/2014 |
|
Contraindications (4) |
9/2014 |
|
Warnings and Precautions |
|
|
Pregnancy: Use with Ribavirin (5.1) |
9/2014 |
|
Impact on Growth in Pediatric Patients (5.15) |
3/2015 |
INDICATIONS AND USAGE
PEGASYS is an antiviral indicated for:
Treatment of Chronic Hepatitis C (CHC) as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs in patients 5 years of age and older with compensated liver disease (1.1)
PEGASYS monotherapy is indicated for:
-
CHC only if patient has contraindication to or significant intolerance to other HCV antiviral drugs (1.1)
-
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 (1.2)
DOSAGE AND ADMINISTRATION
-
PEGASYS is administered by subcutaneous injection (2)
-
In adult patients with CHC or chronic hepatitis B (CHB), PEGASYS is dosed as 180 mcg per week and the duration of treatment depends on indication, genotype, and whether it is administered with other HCV antiviral drugs (2.2, 2.4)
-
In pediatric patients with CHC, PEGASYS is dosed as 180 mcg/1.73 m2 × BSA per week, in combination with ribavirin, and the duration of treatment depends on genotype (2.3)
-
Dosage modification is recommended in patients experiencing certain laboratory abnormalities, adverse reactions or renal impairment (2.5, 12.3)
DOSAGE FORMS AND STRENGTHS
Injection (all presentations below are single-dose):
-
180 mcg/mL in a Vial (3)
-
180 mcg/0.5 mL in a Prefilled Syringe (3)
-
180 mcg/0.5 mL in an Autoinjector (3)
-
135 mcg/0.5 mL in an Autoinjector (3)
CONTRAINDICATIONS
-
Autoimmune hepatitis (4)
-
Hepatic decompensation in patients with cirrhosis (4)
-
Use in neonates/infants (4)
-
Known hypersensitivity reactions such as urt
