Interferon beta-1b is a prescription medicine indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is available as kits. MedsAcross supplies Interferon beta-1b for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Source: US FDA prescribing information
The mechanism of action of BETASERON (interferon beta-1b) in patients with multiple sclerosis is unknown.
Source: US FDA prescribing information
• For subcutaneous use only. • The recommended dose is 0.25 mg every other day. Generally, start at 0.0625 mg (0.25 mL) every other day, and increase over a six-week period to 0.25 mg (1 mL) every other day. • Reconstitute lyophilized powder with supplied diluent
Source: US FDA prescribing information
BETASERON is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation. History of hypersensitivity to natural or recombinant interferon beta, albumin or mannitol
Source: US FDA prescribing information
• Hepatic Injury: Monitor liver function tests and signs and symptoms of hepatic injury, consider discontinuing BETASERON if serious hepatic injury occurs. • Anaphylaxis and Other Allergic Reactions: Discontinue if anaphylaxis occurs. • Depression and Suicide: Advise patients to immediately report any symptom of depression and/or suicidal ideation, consider discontinuation of BETASERON if depression occurs. • Congestive Heart Failure (CHF): Monitor patients with CHF for worsening of cardiac symptoms, consider discontinuation of BETASERON if worsening of CHF occurs. • Injection Site Reactions Including Necrosis: Do not administer BETASERON into affected area until fully healed, if multiple lesions occur, change injection site or discontinue BETASERON until healing of skin lesions. • Leukopenia: Monitor complete blood count.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in more details in other sections of labeling: • Hepatic Injury • Anaphylaxis and Other Allergic Reactions • Depression and Suicide • Congestive Heart Failure • Injection Site Reactions Including Necrosis • Leukopenia • Thrombotic Microangiopathy • Pulmonary Arterial Hypertension • Flu-like Symptom Complex • Seizures • Drug Induced Lupus Erythematosus In controlled clinical trials, the most common adverse reactions (at least 5% more frequent on BETASERON than on placebo) were: injection site reaction, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia.
Source: US FDA prescribing information
Store BETASERON vials between 36°F to 86°F (2°C to 30°C). Do not freeze. Storage BETASERON and the diluent are for single-dose only. After reconstitution, if not used immediately, refrigerate the reconstituted solution and use within three hours.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Interferon beta-1b, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Betaseron kit | Bayer HealthCare Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Interferon beta-1b in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Interferon beta-1b and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Interferon beta-1b, including Betaseron.
Yes. The US FDA first approved Interferon beta-1b on 23 July 1993, according to Drugs@FDA.
Yes. Interferon beta-1b has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Interferon beta-1b is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Interferon beta-1b is classified under ATC code L03AB08 (Interferon beta-1b).
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