It is an antiviral indicated for: Treatment of Chronic Hepatitis C (CHC) in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha,in patients with histological evidence of cirrhosis and compensated liver disease, and in adults with CHC/HIV coinfection and CD4 count greater than 100 cells/mm3 ? Combination therapy with COPEGUS is recommended unless patient has contraindication to or significant intolerance to COPEGUS Its monotherapy is indicated for: ? 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
Peginterferon alfa-2a, is a covalent conjugate of recombinant alfa-2a interferon with a single branched bis-monomethoxy polyethylene glycol chain. The Peginterferon alfa-2a moiety is linked at a single site to the interferon alfa moiety via a stable amide bond to lysine. Peginterferon alfa-2a has an approximate molecular weight of 60,000 daltons. Interferon alfa-2a is produced using recombinant DNA technology in which a cloned human leukocyte interferon gene is inserted into and expressed in Escherichia coli.
it is administered by subcutaneous injection ? In adult patients with CHC or chronic hepatitis B,it is dosed as 180 mcg per week and the duration of treatment depends on indication, genotype,and whether it is administered with COPEGUS ? In pediatric patients with CHC,it is dosed as 180 mcg/1.73 m2 x BSA per week,in combination with COPEGUS,and the duration of treatment depends on genotype . ? Dose reduction is recommended in patients experiencing certain laboratory abnormalities,adverse reactions or renal impairment
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 and dose reduce or discontinue Peginterferon alfa 2a/ Ribavirin or both should event worsen
Zidovudine: monitor for worsening neutropenia and/or anemia with peginterferon alfa/rifavirin
Azathioprine.
Hypersensitivity to any component of the product Autoimmune hepatitis Hepatic decompensation in cirrhotic patients before or during treatment Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients co infected with HIV during or before treatment Neonate or infants.
Depression,suicide,relapse of drug abuse and bacterial infection Flu like symptoms: Fatigue,pyrexia, Gastrointestinal: Nausea/Vomiting,diarrhea,abdominal pain Metabolic and Nutritional: Anorexia Musculoskeletal: Myalgia,arthralgia Neurological: Headache,dizziness,insomnia Psychiatric reactions: Irritability,anxiety Injection site reaction,skin problems,hair loss
Pregnancy Category C: Peginterferon alfa-2a monotherapy. There are no adequate and well controlled trial on pregnant women & developing fetus due to teratogenic effects. Peginterferon alfa-2a is recommended for use in women of childbearing potential only when they are using effective contraception during therapy.
There are limited experiences of overdose. There were no serious reactions attributed to overdose. There is no specific antidote. Dialysis is not effective.
Store in refrigerator at 2-8° C; do not freeze or shake. Protect from light.
.png&w=384&q=75)