Pegasys Injection
Peginterferon Alfa-2a
180mcg
ROCHE Pharma
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| Retail Price | 14470.46 NPR |
Indications
Pegasys Injection is used for:
Chronic hepatitis C, Chronic hepatitis B
Adult Dose
Subcutaneous
Chronic hepatitis C
Adult: 180 mcg SC once weekly for 48 weeks
Treatment duration
Monotherapy: 48 weeks
Dual therapy with Ribavirin
Hepatitis C (Genotype 1 & 4): 48 weeks
Hepatitis C (Genotype 2 & 3): 24 weeks
Chronic Hepatitis B
Adult: 180 mcg SC once weekly for 48 weeks
Dosage Modifications
Neutropenia
ANC <750 cells/mm³: Reduce dose to 135 mcg SC once weekly
ANC <500 cells/mm³: Discontinue treatment until ANC values return to >1000 cells/mm³ and then reinstitute at 90 mcg SC once weekly; monitor ANC
Thrombocytopenia
Platelet <50,000 cells/mm³: Reduce dose to 90 mcg SC once weekly
Platelets <25,000 cells/mm³: Discontinue
Hepatic impairment: Alanine transaminase (ALT) progressively rising above baseline: Decrease dose to 135 mcg/wk.
If ALT continues to rise or is accompanied by increased bilirubin or hepatic decompensation, discontinue immediately.
Child Dose
Chronic Hepatitis C
Indicated in combination with ribavirin for treatment of chronic hepatitis C of children aged >5 yr with CHC and compensated liver disease
<5 years: Safety and efficacy not established
>5 years: 180 mcg/1.73 m² SC qWeek with daily ribavirin
Treatment duration
Genotypes 2, 3: 24 weeks
Genotypes 1, 4: 48 weeks
Renal Dose
Renal impairment
CrCl 30-50 mL/min: 180 mcg once weekly
CrCl <30 mL/min (including patients on hemodialysis): 135 mcg once weekly
If severe adverse reactions or laboratory abnormalities develop, dose can be reduced to 90 mcg once weekly until adverse reactions abate
If intolerance persists after dosage adjustment, discontinued
Administration
Administer by SC injection once weekly in abdomen or thigh
Contra Indications
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.
Precautions
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
Pregnancy-Lactation
Pregnancy Category: C (monotherapy); X (with ribavirin)
Interactions
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.
Adverse Effects
Side effects of Peginterferon Alfa-2a :
>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
Mechanism of Action
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.
Note
Pegasys 180mcg Injection manufactured by ROCHE Pharma. Its generic name is Peginterferon Alfa-2a. Pegasys is availble in Nepal.
Farmaco Nepal drug index information on Pegasys Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.