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Important Safety Information

Do not take BETASERON® (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol. See additional Important Safety Information below.

Important Safety Information
Prescribing Information and Medication Guide
Do not take BETASERON® (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol.
See additional Important Safety Information below.

What is BETASERON®?

Interferons are proteins that affect immune system activity.

BETASERON® (interferon beta-1b) is a type of protein called interferon that occurs naturally in the body. Interferons are proteins whose properties mainly affect the activity of the immune system.4

BETASERON is a prescription medicine used to reduce the number of relapses in people with relapsing forms of multiple sclerosis (MS). This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis. BETASERON will not cure MS but may decrease the number of flare-ups of the disease.

The way BETASERON works is unknown. BETASERON will not cure your MS but may help decrease how often you experience multiple sclerosis flare-ups. Flare-ups (also called relapses or exacerbations) may cause damage to your nerves.4

BETASERON is thought to reduce RRMS relapses by:

  • Blocking certain immune system cells—called T cells—from attacking myelin, the material that protects your nerve fibers
  • Stopping certain types of proteins from activating the immune system to attack your myelin

The exact mechanism of action of interferon beta-1b in patients with multiple sclerosis is unknown.4

The BENEFIT study

The 2-year BENEFIT study evaluated the efficacy and safety of BETASERON in patients with clinically isolated syndrome (CIS). 292 patients received BETASERON and 176 patients received placebo, for a total of 468 patients in the study.4

The BENEFIT study findings:

  1. Early treatment with BETASERON helped significantly delay the time to a second flare-up (conversion to clinically definite MS) compared with placebo.4,5
  2. In the study, common adverse events (AEs) associated with BETASERON included injection-site reactions and flu-like symptoms.4

Indications

BETASERON® (interferon beta-1b) is a prescription medicine used to reduce the number of relapses in people with relapsing forms of multiple sclerosis (MS). This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis. BETASERON will not cure MS but may decrease the number of flare-ups of the disease.


Important Safety Information

Do not take BETASERON (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol.

BETASERON can cause serious side effects, including:

Liver Problems Including Liver Failure. Symptoms of liver problems may include yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting, bruising easily or bleeding problems. Your healthcare provider will do blood tests to check for these problems while you take BETASERON.

Serious Allergic Reactions. Serious allergic reactions can happen quickly and may happen after your first dose of BETASERON or after you have taken BETASERON many times. Symptoms may include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or skin bumps.

Depression or Suicidal Thoughts. Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse or worry you: thoughts about suicide or dying, new or worse depression (sinking feeling or sadness), new or worse anxiety (feeling uneasy, nervous or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being angry, or violent, acting on dangerous impulses, hallucinations, other unusual changes in behavior or mood.

Other possible serious side effects with BETASERON include:

Heart Problems. BETASERON may worsen heart problems including congestive heart failure. Symptoms of heart problems may include swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, not being able to lay flat in bed.

Injection Site Problems. Serious skin reactions can happen in some people including areas of severe damage to skin and the tissue below the skin (necrosis). These reactions can happen anywhere you inject BETASERON. Symptoms of injection site problems may include swelling, redness, or pain at the injection site, fluid drainage from the injection site, breaks in your skin or blue-black skin discoloration. Change your injection site each time you inject BETASERON as it will lessen the chance of you having a serious skin reaction. Avoid injecting BETASERON into an area of the skin that is sore, reddened, infected or has other problems.

Flu-like Symptoms. BETASERON can cause flu-like symptoms including fever, chills, tiredness, sweating, muscle aches when you first start to use it. These symptoms may decrease over time. Taking medicines for fever and pain relief on the days you are using BETASERON may help decrease these symptoms.

Seizures. Some people have had seizures while taking BETASERON, including people who have never had seizures before. It is not known if the seizures were related to MS, to BETASERON, or to a combination of both. If you have a seizure after taking BETASERON call your healthcare provider right away.

Blood Problems. You may have a drop in the levels of infection-fighting white blood cells, red blood cells, or cells that help you form blood clots. If drops in levels are severe, they can lessen your ability to fight infections, make you feel tired or sluggish or cause you to bruise or bleed easily.

Risk to Pregnancy:
BETASERON can harm your unborn baby. BETASERON may cause you to lose your baby (miscarry). If you become pregnant while taking BETASERON call your healthcare provider right away. You and your healthcare provider should decide if you should continue to take BETASERON.

Most Common Side Effects:
The most common side effects of BETASERON include low white blood cell count, increases in your liver enzymes, headache, increase in your muscle tension, pain, rash, problems sleeping, stomach pain, weakness. These are not all the possible side effects of BETASERON.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Tell your healthcare provider about all the medicines you take and your medical conditions.

Please see the full Prescribing Information and Medication Guide for additional information and talk to your healthcare provider.