6800503BS
Brief Summary of
Medication Guide
Betaseron® (bay-ta-seer-on)
Interferon beta-1b
(in-ter-feer-on beta-one-be)
Please read this leaflet carefully before you start to use Betaseron®
and each time your prescription is refilled since there may be new
information. The information in this medication guide does not take
the place of talking with your doctor or healthcare professional.
What is the most important information I should know
about Betaseron?
Betaseron will not cure multiple sclerosis (MS) but it has been
shown to decrease the number of flare-ups of the disease.
Betaseron can cause serious side effects, so before you start taking
Betaseron, you should talk to your doctor about the possible
benefits of Betaseron and its possible side effects to decide if
Betaseron is right for you. Potential serious side effects include:
• Depression. Some patients treated with interferons,
including Betaseron, have become seriously depressed
(feeling sad). Some patients have thought about or have
attempted to kill themselves. Depression (a sinking of spirits
or sadness) is not uncommon in people with multiple
sclerosis. However, if you are feeling noticeably sadder or
helpless, or feel like hurting yourself or others, you should tell
a family member or friend right away and call your doctor or
health care provider as soon as possible. Your doctor may ask
that you stop using Betaseron. Before starting Betaseron, you
should also tell your doctor if you have ever had any mental
illness, including depression, and if you take any medications
for depression.
• Liver problems. Your liver may be affected by taking
Betaseron and a few patients have developed severe liver
injury. Your healthcare provider may ask you to have regular
blood tests to make sure that your liver is working properly. If
your skin or the whites of your eyes become yellow or if you
are bruising easily, you should call your doctor immediately.
• Risk to pregnancy. If you become pregnant while taking
Betaseron you should stop using Betaseron immediately and
call your doctor. Betaseron may cause you to lose your baby
(miscarry) or may cause harm to your unborn child. You and
your doctor will need to decide whether the potential benefit of
taking Betaseron is greater than the potential risks to your
unborn child.
A pregnancy registry has been established to monitor
pregnancy outcomes of women exposed to Betaseron while
pregnant. Providers are encouraged to obtain information on
line at www.BetaseronPregnancyRegistry.com and register
patients by calling 1-800-478-7049.
• Allergic reactions. Some patients taking Betaseron have
had severe allergic reactions leading to difficulty breathing and
swallowing; these reactions can happen quickly. Allergic
reactions can happen after your first dose or may not happen
until after you have taken Betaseron many times. Less severe
allergic reactions such as rash, itching, skin bumps or
swelling of the mouth and tongue can also happen. If you think
you are having an allergic reaction, stop using Betaseron
immediately and call your doctor.
• Injection site problems. Betaseron may cause redness,
pain or swelling at the place where an injection was given. A
few patients have developed skin infections or areas of severe
skin damage (necrosis). If one of your injection sites becomes
swollen and painful or the area looks infected and it doesn't
heal within a few days, you should call your doctor.
• Seizures - Some patients have had seizures while taking
Betaseron, including some patients who have never had
seizures before. It is not known whether the seizures were
related to the effects of their MS, to Betaseron, or to a
combination of both. If you have a seizure while taking
Betaseron, you should stop taking Betaseron and call your
doctor right away.
• Heart problems - While Betaseron is not known to have
direct effects on the heart, a few patients who did not have a
history of heart problems developed heart muscle problems or
congestive heart failure after taking Betaseron. Some of the
symptoms of heart problems are swollen ankles, shortness of
breath, decreased ability to exercise, fast heartbeat, tightness
in chest, increased need to urinate at night, and not being able
to lay flat in bed. If you develop these symptoms or any heart
problems while taking Betaseron, you should call your doctor
right away.
Manufactured by:
Bayer HealthCare Pharmaceuticals Inc.
