Betaferon 50 mcg/1 ml powder for solution for injection, 15 sets: profile, composition and research

Reference page for Betaferon 50 mcg/1 ml powder for solution for injection, 15 sets. Active substance: Интерферон бета-1b / Interferon beta-1b.

Key facts

What interferon beta-1b is

Betaferon is a medicine based on recombinant interferon beta-1b. It is a protein close in structure to the natural human interferon, and it is supplied as a powder from which a solution for injection is prepared.

Interferons are part of the body's natural defence system. They take part in immunity, including reactions linked to viruses and inflammation. That property is the basis of the medicine's use in multiple sclerosis.

A pack holds 15 sets: a vial of powder and its solvent. The solution is prepared just before injection, because the ready mixture does not keep.

Composition and form

The vial contains about 300 mcg (9.6 million IU) of recombinant interferon beta-1b. Once dissolved in 1 ml it gives a solution of about 250 mcg (8.0 million IU) per ml.

The excipients of the powder are human albumin and mannitol. The solvent is a sodium chloride solution with water for injections.

The medicine is given subcutaneously. That means the solution enters the fatty tissue under the skin rather than a muscle or a vein, and is absorbed gradually.

How interferon beta-1b works

In multiple sclerosis immune cells attack myelin, the sheath around nerve fibres in the central nervous system. Interferon beta-1b affects the balance of the signalling molecules that immune cells use to communicate.

It shifts activity towards anti-inflammatory mechanisms and reduces the passage of activated lymphocytes through the blood-brain barrier. As a result, focal inflammation in the nervous system eases.

The medicine does not repair myelin that is already damaged. Its action targets the course of the disease, which is why treatment is long and requires regular follow-up with a neurologist.

Approved uses

The prescribing information names relapsing-remitting multiple sclerosis and the secondary progressive form in patients who continue to have relapses. The medicine is prescribed after the diagnosis and the form of the disease are established.

The dose is chosen by a physician. Treatment usually starts with a smaller volume and builds to the full dose to soften reactions at the beginning. The schedule and the duration are set by a neurologist, not by a reference page.

Published research

Primary sources, verified against PubMed:

• Long-term experience with interferon beta-1b (Betaferon) in multiple sclerosis., PubMed 16170497 (J Neurol, 2005).
• Interferon-beta-1b: a review of its use in multiple sclerosis., PubMed 21128695 (CNS Drugs, 2011).
• Current perspectives on interferon Beta-1b for the treatment of multiple sclerosis., PubMed 25182864 (Adv Ther, 2014).
• Management of patients receiving interferon beta-1b for multiple sclerosis: report of a consensus conference., PubMed 8559358 (Neurology, 1996).

Listed for reference. Publication of a study is not a claim about this particular product.

Precautions

• This is a prescription medicine. Prescribing, dosing and follow-up belong to a neurologist.
• Flu-like symptoms, fever and muscle aches are common reactions at the start. A physician may advise ways to ease them.
• Injection-site reactions are possible: redness, soreness, a lump. Injection sites should be rotated.
• Interferon can affect the liver and the blood, so treatment is accompanied by monitoring tests.
• A history of depression or suicidal thoughts calls for particular caution and specialist supervision.
• In pregnancy and breastfeeding the decision belongs to a physician. Tell them about every medicine you take.

Frequently asked