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 it is recommended unless patient has contraindication to or significant intolerance to 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
Interferon alfa-2a has antiviral, antitumour and immunomodulatory activity. It inhibits replication of a wide range of RNA and DNA viruses. It also exerts antiproliferative effects on normal and malignant cells. Interferon alfa-2a suppresses antibody formation through an effect on B-lymphocytes and inhibits onset of delayed hypersensitivity.
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,PEGASYS 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
Reduces clearance of theophylline. Enhanced myelosuppression with other myelosuppressive drugs (e.g. zidovudine). Drugs metabolised by CYP450 pathway (monitor for changes in pharmacologic or adverse effects of concomitant drug). Increased risk of toxicity of centrally acting drugs. Increased risk of renal failure with interleukin-2.
Autoimmune hepatitis ? Hepatic decompensation in patients with cirrhosis ? Use in neonates/infants ? Known hypersensitivity reactions such as urticaria,angioedema,bronchoconstriction and anaphylaxis to alpha interferons or any component of the product Additional contraindications for use with ribavirin: ? Pregnant women and men whose female partners are pregnant ? Hemoglobinopathies (e.g.,thalassemia major,sickle cell disease) ? Coadministration with didanosine - Use with Ribavirin ? Birth defects and fetal death: patients must have a negative pregnancy test prior to therapy,use 2 or more forms of contraception,and have monthly pregnancy tests ? Hemolytic anemia ? History of significant or unstable cardiac disease Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy: ? Neuropsychiatric events ? Autoimmune and endocrine disorders (including thyroid disorders; hyperglycemia) ? Ophthalmologic disorders ? Cerebrovascular disorders ? Hepatic decompensation in cirrhotic patients. Exacerbation of hepatitis during hepatitis B treatment (5.9) ? Pulmonary disorders ? Infections (bacterial,viral,fungal) ? Bone marrow suppression ? Colitis and pancreatitis ? Hypersensitivity and serious skin reactions including Stevens-Johnson syndrome ? Growth impairment with combination therapy in pediatric patients ? Peripheral neuropathy when used in combination with telbivudine
fatigue/asthenia,pyrexia,myalgia,and headache
Pregnancy Category: Interferon Alfa-2a should be administered only if the benefit to the woman justifies the potential risk to the foetus. Although animal tests do not indicate that Roferon-A is a teratogen, harm to the foetus from use during pregnancy cannot be excluded. When doses greatly in excess of the recommended clinical dose were administered to pregnant rhesus monkeys in the early to mid foetal period, an abortifacient effect was observed.
Nursing mothers: It is not known whether Interferon Alfa-2a is secreted in human milk. A decision must be taken whether to suspend breast-feeding or to discontinue the medicine, taking into account the importance of the medicine to the mother.
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