Active Substance: Peginterferon alfa-2a.
Overview
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This medicine contains an important and useful components, as it consists of
Peginterferon alfa-2ais available in the market in concentration
Peginterferon Alfa-2a
Neuropsychiatric disorders, discontinue treatment with worsening or persistently severe signs/symptoms; myelosuppresion; anemia (spherocytosis, history of GI bleeding); pulmonary disease; autoimmune disease; cardiovascular disease; DM; infectious disorders; ischaemic disorders; renal impairment; thyroid disorders; patients who have failed other alpha interferon therapy, received organ transplants, been coinfected with Hepatis B or C virus or HIV; or with Hepatitis C virus and HIV with a CD4+ cell count <100 cells/microliter, or been treated for >48 wk. Elderly. Safety and efficacy not been established in children. Do not change brands of interferon without the concurrence of healthcare provider (product variability). More frequent monitoring of LFTs and dose reduction in Hepatitis B. Hazardous agent, handle and dispose appropriately. May affect ability to drive or operate machinery. Lactation: Unknown if distributed in human breast milk; because of the potential for adverse reactions from the drugs in nursing infants, a decision must be made whether to discontinue nursing or discontinue the drug
Chronic hepatitis C, Chronic hepatitis B
Hypersensitivity to any component of the product. Autoimmune hepatitis; decompensated liver disease in cirrhotic patients (Child-Pugh score >6); decompensated liver disease (Child-Pugh score >6, class B and C) in chronic hepatitis C coinfected with HIV; neonates and infants; in combination with ribavirin in pregnant women.
>10% Fatigue (24% to 67% ),Headache (27% to 54% ),Fever (24% to 54% ),Myalgia (26% to 51% ),Influenza-like illness (25% to 47% ),Rigor (25% to 47% ),Neutropenia (21% to 40% ),Anxiety (19% to 33% ),Feeling nervous (19% to 33% ),Irritability (19% to 33% ),Diarrhea (11% to 31% ),Injection site inflammation (10% to 31% ),Insomnia (19% to 30% ),Arthralgia (22% to 28% ),Alopecia (18% to 28% ),Abdominal pain (8% to 26% ),Nausea and vomiting (5% to 25% ),Loss of appetite (16% to 24% ),Injection site reaction (22% to 23% ),Dizziness (13% to 23% ),Depression (18% to 20% ),Pruritus (12% to 19% ),Dermatitis (8% to 16% ),Weight decreased (4% to 16% ),Lymphocytopenia (Severe) (5% to 14% ),Anemia (2% to 14%),Lymphocyte count abnormal (3% to 14% ),Dyspnea (4% to 13% ) 1-10% Reduced concentration (8% to 10% ),Cough (4% to 10% ),Dry skin (4% to 10% ),Rash (5% to 8% ),Thrombocytopenia (5% to 8% ),Bacterial infectious disease (3% to 5%), Severe bacterial infection (1-3%) <1% Angina,Cardiac dysrhythmia,Aggressive behavior,Cerebral hemorrhage,Cerebral ischemia,Coma,Drug Abuse,Peripheral neuropathy,Psychotic disorder,Suicide,Diabetes mellitus,Colitis,Gastrointestinal hemorrhage,Pancreatitis,Peptic ulcer disease,Aplastic anemia,Thrombotic thrombocytopenic purpura,Abnormal liver function,Cholangitis,Liver failure,Steatosis of liver,Myositis,Corneal ulcer,Pulmonary embolism Frequency Not Defined Myocardial infarction,Erythroderma (rare),Stevens-Johnson syndrome (rare),Hypo/hyperthyroidism,Hypo/hyperglycemia,Anemia (severe),Cytopenia (severe),Autoimmune disease (rare),Hypersensitivity reaction (severe),Serous retinal detachment,Pulmonary infiltrates,Liver graft rejection and renal graft rejection
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Peginterferon alfa-2a are interferon proteins bound to polyethylene glycol (PEG) molecules resulting in higher and more prolonged serum interferon concentrations. It has antiviral, antiproliferative and immune-regulating activity. Interferons are activated when it interacts with cells through high affinity cell surface receptors. The effects of this activation include the induction of gene transcription, inhibition of cellular growth, alteration of cellular differentiation, interference with oncogene expression, alteration of cell surface antigen expression, increase in phagocytic activity of macrophages and augmentation of cytotoxicity of lymphocytes for target cells.
Increased risk of haemolytic anemia, birth defects and/or foetal mortality, genotoxicity, mutagenicity, and may possibly be carcinogenic with ribavirin; decreases metabolism of theophylline; enhances adverse/toxic effects of zidovudine, decreases metabolism of zidovudine. Avoid ethanol in hepatitis C virus patients.
Pregnancy Category: C (monotherapy); X (with ribavirin)