Finished product reference
Interferon Beta-1b
Injection, Powder, for Solution · Parenteral · 9600000 IU
- List code
- 12560
- Pharmacologic class
- Immunomodulator: recombinant interferon beta-1b
What it is and how it works
Interferon beta-1b is a non-glycosylated recombinant interferon beta produced in Escherichia coli. It modulates the immune response in multiple sclerosis by reducing pro-inflammatory cytokines, inhibiting T-cell activation and limiting leucocyte migration across the blood–brain barrier.
Indications
Relapsing–remitting multiple sclerosis, secondary progressive MS with active disease, and a single demyelinating event (clinically isolated syndrome) at high risk of developing MS.
Dosage and administration (summary)
250 micrograms by subcutaneous injection every other day, with gradual dose titration over the first weeks of treatment.
Contraindications
Hypersensitivity to natural or recombinant interferon beta, human albumin or excipients; current severe depression and/or suicidal ideation; decompensated liver disease.
Warnings and precautions
Depression and suicidal ideation, hepatic injury, thrombotic microangiopathy, nephrotic syndrome, blood dyscrasias and thyroid dysfunction may occur; monitor blood counts and liver and thyroid function. Injection-site reactions, including necrosis, and flu-like symptoms are common. Use with caution in patients with seizure disorders or cardiac disease.
Pregnancy
May be used during pregnancy if clinically needed, based on available registry data.
Storage and supply
Store below 25 °C; do not freeze.
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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