The Hepatitis C Physician eGuide contains educational tools useful in helping physicians treat patients with chronic hepatitis C who have compensated liver disease and not previously treated with interferon alpha. INDICATIONS AND USAGE PEGASYS (peginterferon alfa-2a) is an antiviral indicated for the treatment of Chronic Hepatitis C in adults with compensated liver disease not previously treated with interferon alpha and in patients with histological evidence of cirrhosis and compensated liver disease. Combination Therapy with COPEGUS is recommended unless patient has contraindication to or significant intolerance to COPEGUS. Boxed WARNINGS Alpha interferons, including PEGASYS, 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 Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions.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. Use with Ribavirin. Ribavirin, including COPEGUS, may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. CONTRAINDICATIONS Autoimmune hepatitis Hepatic decompensation in patients with cirrhosis Use in neonates/infants Known hypersensitivity reaction 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 in combination therapy with COPEGUS Hemoglobinopathies (e.g., thalassemia major, sickle‐cell anemia) Coadministration with didanosine WARNINGS AND PRECAUTIONS 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 Cardiovascular disorders Autoimmune and endocrine disorders (including thyroid disorders; hyperglycemia) Ophthalmologic disorders Cerebrovascular disorders Hepatic decompensation in cirrhotic patients Pulmonary disorders Infections (bacterial, viral, fungal) Bone marrow suppression Colitis and pancreatitis Hypersensitivity and serious skin reactions including Stevens-Johnson Syndrome Peripheral neuropathy when used in combination with telbivudine Pancytopenia when used in combination with azathioprine ADVERSE REACTIONS Most common life-threatening or fatal events (each occurring at a frequency of <1%) induced or aggravated by PEGASYS and COPEGUS: depression, suicide, relapse of drug abuse/overdose, bacterial infections The most common serious adverse event (3%): bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia) Most commonly reported adverse reactions: psychiatric reactions including depression, insomnia, irritability, anxiety and flu-like symptoms such as fatigue, pyrexia, myalgia, headache, rigors) Other common reactions: anorexia, nausea, vomiting, diarrhea, arthralgias, injection site reactions, alopecia, pruritus Post‐approval adverse reactions of PEGASYS, with or without ribavirin, include pure red cell aplasia, hearing impairment, hearing loss, liver graft rejection, renal graft rejection, dehydration, serious skin reactions, seizures See full PEGASYS and COPEGUS prescribing information for complete indication and important safety information.
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