Peginterferon alfa-2a

PEGASYS is an inducer of the innate immune response indicated for the treatment of Chronic Hepatitis C (CHC). Adult Patients: In combination therapy with other hepatitis C virus drugs for adults with compensated liver disease. PEGASYS monotherapy is indicated only if patient has contraindication or significant intolerance to other HCV drugs. Pediatric Patients: In combination with ribavirin for pediatric patients 5 years of age and older with compensated liver disease Chronic Hepatitis B (CHB).

Pegylated recombinant human interferon alfa-2a is an inducer of the innate antiviral immune response.

PEGASYS is administered by subcutaneous injection. In adult patients with CHC, 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. In adult patients with CHB, PEGASYS is dosed as 180 mcg per week for 48 weeks. In pediatric patients with CHC, PEGASYS is dosed as 180 mcg/1.73 m 2 × BSA per week, in combination with ribavirin, and the duration of treatment depends on genotype. In pediatric patients with CHB, PEGASYS is dosed as 180 mcg/1.73 m 2 × BSA per week for 48 weeks: Dosage modification is recommended in patients experiencing certain laboratory abnormalities, adverse reactions or renal impairment

PEGASYS is contraindicated in patients with: Known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction, anaphylaxis, or Stevens-Johnson syndrome to alpha interferons, including PEGASYS, or any of its components. Autoimmune hepatitis Hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic patients before treatment Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before treatment PEGASYS is contraindicated in neonates and infants because it contains benzyl alcohol.

Boxed warning (risk of serious disorders warning: risk of serious disorders): 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. Refer to the prescribing information of the other HCV antiviral drugs, including ribavirin, for their Warnings and Precautions. Use with ribavirin Birth defects and fetal death: patients must have a negative pregnancy test prior to therapy, use 2 forms of effective contraception, and have monthly pregnancy tests. PEGASYS Clinically Significant Adverse Reactions or Risks Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: Neuropsychiatric reactions. Cardiovascular disorders.

In clinical trials, a broad variety of serious adverse reactions were observed in 1,010 subjects who received PEGASYS at doses of 180 mcg for 48 weeks, alone or in combination with ribavirin. The most common life-threatening or fatal events induced or aggravated by PEGASYS and ribavirin include depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of less than 1%. Hepatic decompensation occurred in 2% (10/574) of CHC/HIV subjects. Adult subjects: The most common adverse reactions (incidence greater than 40%) are fatigue/asthenia, pyrexia, myalgia, and headache. Pediatric subjects: The most common adverse reactions are similar to those seen in adults

Drugs metabolized by CYP1A2: monitor for increased serum levels of theophylline and adjust dose accordingly. Methadone: monitor for signs and symptoms of methadone toxicity. Nucleoside analogues: closely monitor for toxicities. Reduce or discontinue the dose of PEGASYS or ribavirin or both should the events worsen. Zidovudine: monitor for worsening neutropenia and/or anemia with PEGASYS and/or ribavirin

Store in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not leave PEGASYS out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect from light.