Betaseron (interferon beta-1b)

Reviewed by: HU Medical Review Board | Last reviewed: April 2023

Betaseron® is an interferon beta approved to treat clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive MS (SPMS). It is a disease-modifying drug (DMD) given by subcutaneous injection (under the skin).1

Betaseron is intended to reduce the incidence of clinical exacerbations. An exacerbation is the appearance of a new clinical symptom or the clinical worsening of a previous symptom that lasts for a minimum of 24 hours. Betaseron is prescribed for people who present MRI results that contain features consistent with multiple sclerosis lesions.1

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.1

What are the ingredients in Betaseron?

The active ingredient in Betaseron is interferon beta-1b.1

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.1

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:1

  • 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

These are not all the possible side effects of Betaseron. Talk to your doctor about what to expect when taking Betaseron. You also should call your doctor if you have any changes that concern you when taking Betaseron.

Other things to know about Betaseron

Before starting Betaseron, talk with your doctor if you:1

  • 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. Based on data from animal studies, Betaseron can harm an unborn baby. It should be used only if the potential benefit of Betaseron therapy exceeds risk to the fetus.

People with the above conditions should be monitored closely while taking Betaseron. Before beginning treatment for MS, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.1

For more information, read the full prescribing information of Betaseron.

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