Betaseron (interferon beta-1b)

Reviewed by: HU Medical Review Board | Last reviewed: February 2022. | Last updated: April 2022

Betaseron® is an interferon beta indicated for clinically isolated syndrome (CIS), relapsing-remitting MS, and active secondary progressive MS (SPMS). It is a disease-modifying drug (DMD) administered by subcutaneous injection (under the skin). Betaseron is intended to reduce the incidence of clinical exacerbations. An exacerbation is the appearance of a new clinical sign/symptom or the clinical worsening of a previous sign/symptom that persists for a minimum of 24 hours. Betaseron is prescribed for people who present MRI results that contain features consistent with multiple sclerosis lesions.

What is an interferon?

Betaseron is an interferon, a group of glycoproteins produced naturally in the body in response to viral infections. Lyophilized Betaseron is a sterile, white to off-white powder, injected after being reconstituted with the diluent solution supplied. Each vial contains albumin and mannitol. The active ingredient in Betaseron is interferon beta-1b.

How does Betaseron work?

The way Betaseron works is not well understood. It is thought to act by reducing inflammation and the immune response that attacks the body’s myelin.

What are the possible side effects?

Many clinical trials evaluated the safety and efficacy of Betaseron. The most common side effects experienced by those taking Betaseron include:

  • Injection site reactions
  • Flu-like symptoms
  • Abdominal pain
  • Depression
  • Elevated liver enzymes
  • Blood count abnormalities
  • Headache
  • Asthenia (i.e.lack of energy or physical weakness)
  • Insomnia
  • Rash

This is not an exhaustive list of all potential side effects of Betaseron. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Betaseron, contact your doctor or healthcare provider immediately.

Flu-like symptoms can generally be treated with over-the-counter pain relief medications.

Things to know about Betaseron

Betaseron is a sterile powder that contains no preservatives and comes in a single-use vial for reconstitution. It should be stored at room temperature. Betaseron can also be administered with an electronic auto-injector called Betaconnect. Before starting Betaseron talk with your doctor if you:

  • Have a history of hypersensitivity to natural or recombinant interferon beta or human albumin, or mannitol.
  • Have hepatic (liver) injury
  • Have a history of anaphylaxis
  • Have a history of depression or suicidal ideation. Any new symptoms of depression, suicidal ideation, and/or psychosis should be reported immediately to your doctor.
  • Have congestive heart failure
  • Experience injection site reactions or necrosis
  • Have low blood counts
  • Have Thrombotic Microangiopathy (damage to small blood vessels in vital organs)
  • Have flu-like symptoms
  • Experience development of new autoimmune disorders
  • Are pregnant or planning to get pregnant, as there is limited information on the use of Betaseron in pregnancy. It should be used only if the potential benefit of Betaseron therapy exceeds risk to the fetus.

Individuals with the above conditions should be monitored closely while taking Betaseron.

For additional details, read the full prescribing information of Betaseron.

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