peginterferon alfa-2b

Safety and efficacy in pediatrics less than 3 years old have not been established. Neuropsychiatric, cardiac, pulmonary, GI, and systemic (flu-like) adverse reactions may be more severe in geriatric patients. Safety and efficacy have not been estacblished in HIV or HBV co-infected and organ transplant patients. It is contraindicated in patients with creatinine clearance less than 50 mL/min. It is also contraindicated in pregnant women and patients with Hemoglobinopathies when taken in combination with ribavirin. Birth defects and fetal death with ribavirin: Patients must have a negative pregnancy test prior to therapy, use at least 2 forms of contraception, and undergo monthly pregnancy tests. Patients exhibiting the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy: Hemolytic anemia with ribavirin. Neuropsychiatric events. History of significant or unstable cardiac isease. Hypothyroidism, hyperthyroidism, hyperglycemia, diabetes mellitus that cannot be effectively treated by medication. New or worsening ophthalmologic disorders. Ischemic and hemorrhagic cerebrovascular events. Severe decreases in neutrophil or platelet counts. History of autoimmune disorders. Pancreatitis and ulcerative or hemorrhagic/ischemic colitis and pancreatitis. Pulmonary infiltrates or pulmonary function impairment. Child-Pugh score greater than 6 (class B and C). Increased creatinine levels in patients with renal insufficiency. Serious, acute hypersensitivity reactions and cutaneous eruptions. Dental/periodontal disorders reported with combination therapy. Hypertriglyceridemia may result in pancreatitis (e.g., triglycerides greater than 1000 mg/dL). Weight loss and growth inhibition reported with combination therapy in pediatric patients. Peripheral neuropathy when used in combination with telbivudine.