Peginterferon Alfa-2b

What it is and how it works

Peginterferon alfa-2b is recombinant interferon alfa-2b covalently conjugated to a 12 kDa linear polyethylene glycol, prolonging its half-life. It binds type I interferon receptors and induces antiviral, antiproliferative and immunomodulatory effects.

Indications

Chronic hepatitis C in adults and children from 3 years, in combination with ribavirin or other antivirals (largely superseded by interferon-free regimens); adjuvant treatment of resected high-risk melanoma in some markets.

Dosage and administration (summary)

Subcutaneous injection once weekly, dose calculated by body weight (for hepatitis C typically 1.5 micrograms/kg weekly with ribavirin); duration depends on genotype, regimen and response.

Contraindications

Autoimmune hepatitis or other autoimmune disease, severe hepatic dysfunction or decompensated cirrhosis, severe pre-existing cardiac disease, severe psychiatric conditions, uncontrolled thyroid disease and epilepsy or CNS dysfunction; ribavirin combination is contraindicated in pregnancy.

Warnings and precautions

Neuropsychiatric effects including severe depression and suicidal behaviour may occur. Bone marrow suppression, thyroid dysfunction, retinopathy, autoimmune and ischaemic events, and hepatic decompensation require regular monitoring of blood counts, liver and thyroid function and eye examinations. Influenza-like symptoms and fatigue are common.

Pregnancy

Use only if clearly needed; combination with ribavirin is contraindicated and requires effective contraception in both sexes during and after treatment.

Storage and supply

Store as specified by the manufacturer (powder usually at 2–8 °C); reconstituted solution should be used promptly or refrigerated for a limited time.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.