Interferon Beta-1b, Injection

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KEY POINTS

• This medicine is given by injection to reduce the frequency of attacks caused by multiple sclerosis. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause depression, thoughts of suicide, and other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: biological response modulator;

Generic and brand names: interferon beta-1b, injection; Betaseron; Extavia

What is this medicine used for?

This medicine is given by injection (shots) just under the skin to reduce the frequency of attacks caused by multiple sclerosis (MS).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, or to albumin or mannitol
• A blood disorder
• Depression or thoughts of suicide
• Heart problems
• Kidney or liver disease
• Seizures
• Thyroid problems

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Using this medicine while you are pregnant may cause you to have a miscarriage or harm your unborn baby. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is given by subcutaneous (under the skin) injections. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. If your healthcare provider is giving you the shots, keep all your appointments.

Sometimes you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Change your injection site each time you inject this medicine. Do not inject this medicine into an area of skin that is sore, reddened, infected or has other problems.

What if I miss a dose?

If you miss a dose, take your next dose as soon as you remember. However, do not take this medicine 2 days in a row. If you accidentally take more than the prescribed dose or take it 2 days in a row, contact your healthcare provider right away.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine can cause depression and thoughts of suicide. If you have these symptoms, or if you have unusual mood or behavior changes, contact your healthcare provider right away.

You may develop a reaction at the spot where you inject the medicine. This is usually temporary, but if reactions continue or get worse, contact your healthcare provider.

You may develop flulike symptoms (fever, chills, muscle aches) when you first start this treatment. Taking medicines for fever and pain relief on the days you use this medicine may help relieve these symptoms. Ask your healthcare provider about this.

You need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine is made from human blood. It is tested for viruses such as hepatitis and HIV. The risk of getting an infection from this medicine is very low, but it is still possible. Talk with your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe depression or thoughts of suicide; unusual mood or behavior changes; hallucinations; chest pain; fast heartbeat; broken skin, sores, bruising, swelling, oozing, or severe pain at the injection site; unusual bruising or bleeding; extreme tiredness or weakness; yellowing of skin or eyes; unexplained or severe stomach pain; swelling in hands, ankles, or feet; shortness of breath; swollen or painful lymph glands; unexplained fever; trouble urinating; vision changes; seizures.

Other: Fever, chills, tiredness, sweating, headache, stomach pain, diarrhea, constipation, vomiting, trouble sleeping, menstrual problems, muscle or joint pain, stuffy nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• HIV medicines such as delavirdine (Rescriptor), didanosine (Videx), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), and zidovudine (Retrovir)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature before it is mixed. Protect from heat, high humidity, and bright light. Refrigerate medicine after it is mixed and use it within 3 hours. Discard any medicine left in the vial. Put used needles in rigid puncture-resistant containers with lids or caps, such as heavy plastic bleach bottles with screw caps. DO NOT throw needles directly into garbage cans or dumpsters.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.