Finished product reference
Peginterferon Alfa-2a
Injection · Parenteral · 360 µg/1mL · 0.5 mL
- List code
- 50202
- Pharmacologic class
- Immunomodulator and antiviral; pegylated interferon alfa-2a
What it is and how it works
Peginterferon alfa-2a is recombinant interferon alfa-2a conjugated to a 40 kDa branched polyethylene glycol, which prolongs its half-life and allows weekly dosing. It binds type I interferon receptors and induces antiviral, antiproliferative and immunomodulatory gene expression.
Indications
Chronic hepatitis B (HBeAg-positive or -negative) in adults and children from 3 years; chronic hepatitis C, usually in combination with ribavirin or other antivirals (now largely superseded by interferon-free direct-acting antiviral regimens).
Dosage and administration (summary)
Subcutaneous injection: adults 180 micrograms once weekly, for 48 weeks in chronic hepatitis B; duration in hepatitis C depends on genotype and regimen; dose reduced for neutropenia, thrombocytopenia or other toxicity.
Contraindications
Autoimmune hepatitis, severe hepatic dysfunction or decompensated cirrhosis, history of severe pre-existing cardiac disease, severe psychiatric disorders, uncontrolled thyroid disease, neonates (benzyl alcohol), and combination with telbivudine; ribavirin combination is contraindicated in pregnancy.
Warnings and precautions
Severe depression, suicidal ideation and other neuropsychiatric effects may occur; monitor closely. Causes neutropenia, thrombocytopenia, thyroid dysfunction, autoimmune disorders, ophthalmological disorders and hepatic decompensation in cirrhosis; regular blood counts, liver and thyroid tests are required. Influenza-like symptoms are common.
Pregnancy
Use only if clearly needed; combination with ribavirin is contraindicated and requires strict contraception in both female patients and female partners of male patients.
Storage and supply
Store at 2–8 °C in a refrigerator; do not freeze; protect from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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