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Brand Names: Betaseron, Extavia

Generic Name: interferon beta-1b (Pronunciation: in ter FEAR on BAY ta 1b)

• What is interferon beta-1b (Betaseron)?
• What are the possible side effects of interferon beta-1b (Betaseron)?
• What is the most important information I should know about interferon beta-1b (Betaseron)?
• What should I discuss with my healthcare provider before using interferon beta-1b (Betaseron)?
• How should I use interferon beta-1b (Betaseron)?
• What happens if I miss a dose (Betaseron)?
• What happens if I overdose (Betaseron)?
• What should I avoid while using interferon beta-1b (Betaseron)?
• What other drugs will affect interferon beta-1b (Betaseron)?
• Where can I get more information?

What is interferon beta-1b (Betaseron)?

Interferon beta-1b is made from human proteins. Interferons help the body fight viral infections.

Interferon beta-1b is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

Interferon beta-1b may also be used for other purposes other than those listed in this medication guide.

What are the possible side effects of interferon beta-1b (Betaseron)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using interferon beta-1b and call your doctor at once if you have any of these serious side effects:

• depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;
• bruising, swelling, oozing, or skin changes where the injection was given;
• weight changes, pounding heartbeats, feeling too hot or cold;
• fever, chills, body aches, flu symptoms; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• weakness;
• headache;
• muscle pain or weakness;
• sleep problems (insomnia);
• stomach pain;
• swelling in your hands or feet;
• skin rash; or
• irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about interferon beta-1b (Betaseron)?

This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1b if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using interferon beta-1b, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, a bleeding or blood-clotting disorder, anemia (low red blood cells), or a history of depression or suicidal behavior.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1b if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

Interferon beta-1b is given as an injection under the skin, usually at bedtime every 48 hours (2 days). You may be given instructions on how to use your injections at home. You may be shown how to inject your medicine at home.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

To be sure this medication is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.