Interferon beta-1b is used to treat is used to treat relapsing forms of multiple sclerosis (MS). interferon beta-1b will not cure MS, but it may decrease flare-ups.

Interferon beta-1b may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of a serious allergic reaction, such as a rash, itching, or swelling in your mouth or tongue.

Some people have thoughts about suicide while taking interferon beta-1b. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Interferon beta-1b can harm your liver. Call your doctor at once if you have nausea, vomiting, itching, bruising or bleeding, or yellowing of your skin or eyes.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Interferon beta-1b is injected under the skin, usually every other day. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject interferon beta-1b. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

You will need frequent medical tests.

Store unmixed interferon beta-1b and the diluent at cool room temperature away from moisture and heat.

After mixing, store the medicine in the refrigerator and use within 3 hours. Do not freeze.

Each single-use vial (bottle) or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside. Throw away any interferon beta-1b that is not used within 3 months.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Multiple Sclerosis:

Initial dose: 0.0625 mg subcutaneously every other day, and increased (in 25% increments) every 2 weeks, over a 6 week period, to maintenance dose
Maintenance dose: 0.25 mg subcutaneously every other day

Schedule for dose titration:
Weeks 1 and 2: 0.0625 mg subcutaneously every other day (25% of recommended dose)
Weeks 3 and 4: 0.125 mg subcutaneously every other day (50% of recommended dose)
Weeks 5 and 6: 0.1875 mg subcutaneously every other day (75% of recommended dose)
Week 7 and beyond: 0.25 mg subcutaneously every other day (100% of recommended dose)

Use: For the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

You should not use interferon beta-1b if you are allergic to interferon beta, albumin, or mannitol.

Tell your doctor if you have ever had:

• liver disease;

• heart problems;

• a seizure;

• depression, anxiety, or sleep problems;

• a bleeding or blood-clotting disorder;

• low white blood cell (WBC) counts;

• anemia (lack of red blood cells); or

• an allergy to latex.

Tell your doctor if you are pregnant or breastfeeding.

Use the missed dose as soon as you remember. Then wait at least 48 hours (2 days) before using another injection, and restart your dosing schedule at that time. Do not use more than one injection every 48 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid injecting interferon beta-1b into skin that is sore, red, or infected.

Avoid drinking alcohol. It may increase your risk of liver problems.

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

Some patients using interferon medicines have become very depressed or had thoughts of suicide. Report any new or worsening symptoms of depression to your doctor, such as: mood or behavior changes, anxiety, trouble sleeping, hallucinations, or if you feel impulsive, hostile, aggressive, depressed, or have thoughts about suicide or hurting yourself.

Interferon beta-1b may cause serious side effects. Stop using interferon beta-1b and call your doctor at once if you have:

• fever, chills, sweating, tiredness, body aches;

• a seizure;

• pain, swelling, redness, or skin changes where an injection was given;

• heart problems--chest tightness, swelling, rapid weight gain, trouble lying flat in bed, feeling short of breath;

• liver problems--nausea, vomiting, itching, easy bruising, unusual bleeding, dark urine, jaundice (yellowing of your skin or eyes); or

• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Common side effects of interferon beta-1b may include:

• low white blood cell counts;

• abnormal liver function tests;

• headache, weakness;

• sleep problems (insomnia);

• stomach pain;

• muscle pain, stiffness, or weakness;

• rash;

• flu symptoms; or

• a skin reaction where the medicine was injected.

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.

Other drugs may affect interferon beta-1b, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.