Momentum - Summer 2013

Brief Summary of
Medication Guide
Betaseron® (bay-ta-seer-on)
Interferon beta-1b
(in-ter-feer-on beta-one-be)

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 about Betaseron?

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 children.

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.

(interferon beta-1b)

injection 0.3 mg

6800505BS

521-154-0002-13

What should I tell my healthcare provider before taking Betaseron?

Before you take Betaseron, tell your healthcare provider if you:

• 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 pharmacist.

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 children.

General information about the safe and effective use of Betaseron.

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 harm them.