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Pegin 135
Beacon Pharmaceuticals PLC
Generic: Peginterferon Alfa-2a
Medicine Overview of Pegin 135 135mcg/vial Injection
বাংলা
English
Indication
Chronic hepatitis C, Chronic hepatitis B
Administration
Administer by SC injection once weekly in abdomen or thigh
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 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...
... Show moreChild 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: 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
Contraindication
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.
Mode 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.
Precaution
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 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...
... Show moreSide Effect
>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%...
... Show morePregnancy Category Note
Pregnancy Category: C (monotherapy); X (with ribavirin)
Interaction
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.
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