Brief Summary of
This information does not include all the important
information about Betaseron. For more information about
Betaseron go to www.BETASERON.com.
What is the most important information I should know
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, new or worse anxiety, trouble sleeping
(insomnia), acting aggressive, being angry, or violent,
acting on dangerous impulses, hallucinations, other
unusual changes in behavior or mood.
What is Betaseron?
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 is
similar to certain interferon proteins that are produced in
the body. It will not cure your MS but may decrease the
number of flare-ups of the disease.
It is not known if Betaseron is safe and effective in
Who should not take Betaseron?
Do not take Betaseron if you are allergic to interferon
beta-1b, to another interferon beta, to human
albumin, or mannitol. See the end of this leaflet for a
complete list of ingredients in Betaseron.
injection 0.3 mg
What should I tell my healthcare provider before
Before you take Betaseron, tell your healthcare provider
• have or have had depression (sinking feeling or
sadness), anxiety (feeling uneasy, nervous, or fearful
for no reason) or trouble sleeping
• have or have had liver problems
• have or have had blood problems such as bleeding
or bruising easily, low red blood cells (anemia) or
low white blood cells
• have or have had seizures
• have or have had heart problems
• are pregnant or plan to become pregnant. 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.
• are breastfeeding or plan to breastfeed. It is not
known if Betaseron passes into your breast milk. You
and your healthcare provider should decide if you will
take Betaseron or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines
you take, including prescription and nonprescription
medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to
show your healthcare provider and pharmacist when
you get a new medicine.
What are the possible side effects of Betaseron?
Betaseron may cause serious side effects. Call your
healthcare provider right away if you have any of the
serious side effects of Betaseron including:
• See “What is the most important information I should
know about Betaseron?”
• 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
It is important for you to change your injection site each
time you inject Betaseron. This will lessen the chance of
you having a serious skin reaction at the site where you
inject Betaseron. Avoid injecting Betaseron into an area of
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 their MS, to Betaseron, or to a combination of
both. If you have a seizure after taking Betaseron call
your healthcare provider right away.
The most common side effects of Betaseron include: low
white blood cell count, increases in your liver enzymes,
headache, increases in your muscle tension, pain, rash,
problems sleeping, stomach pain, weakness.
Tell your healthcare provider if you have any side effect
that bothers you or that does not go away.
These are not all the possible side effects of Betaseron.
For more information, ask your healthcare provider or
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
Keep Betaseron and all medicines out of the reach of
General information about the safe and effective use of
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use
Betaseron for a condition for which it was not
prescribed. Do not give Betaseron to other people, even
if they have the same symptoms that you have. It may
What are the ingredients in Betaseron?
Active ingredient: interferon beta-1b
Inactive ingredients: albumin (human), mannitol
Diluent contains sodium chloride solution.
Bayer HealthCare Pharmaceuticals Inc.