Finished product reference

Interferon Beta-1a

Injection, Powder, for Solution · Parenteral · 6000000 IU

List code
2667
Pharmacologic class
Immunomodulator: recombinant interferon beta-1a

What it is and how it works

Interferon beta-1a is a glycosylated recombinant protein identical in amino-acid sequence to human interferon beta. In multiple sclerosis it reduces pro-inflammatory cytokine production, inhibits T-cell activation and migration across the blood–brain barrier and enhances anti-inflammatory mediators.

Indications

Relapsing forms of multiple sclerosis (relapsing–remitting MS, and clinically isolated syndrome at high risk of conversion), to reduce relapse frequency and slow disability progression.

Dosage and administration (summary)

Depending on the product: 30 micrograms by intramuscular injection once weekly, or 22–44 micrograms by subcutaneous injection three times weekly with dose titration at initiation; pegylated interferon beta-1a 125 micrograms subcutaneously every 2 weeks.

Contraindications

Hypersensitivity to natural or recombinant interferon beta or excipients; current severe depression and/or suicidal ideation; initiation in pregnancy is not generally recommended (see product information).

Warnings and precautions

Depression and suicidal ideation, hepatic injury, thrombotic microangiopathy, nephrotic syndrome, blood dyscrasias, thyroid dysfunction and injection-site reactions or necrosis may occur; monitor full blood count, liver and thyroid function. Flu-like symptoms are common at initiation and can be reduced with dose titration and analgesics. 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 at 2–8 °C; do not freeze; may be kept below 25 °C for a limited period if the product information permits.

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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