Interferon Beta-1b (in-ter-FEER-on BAY-ta-1b)

Reduces flare-ups of multiple sclerosis (MS).

Brand Name(s):

Betaseron, Extavia

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. This medicine is given every other day with 48 hours between doses.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• The powder medicine must be mixed with the liquid provided before it is given. Do not shake the medicine after you mix it.
• Use the medicine right away after you mix it. Each vial of medicine should be used only once. Do not save any unused medicine.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• You may also receive medicine to help prevent flu-like symptoms.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Wait at least 48 hours (2 days) between injections.
• If you store this medicine at home, keep it at room temperature, away from heat, moisture, and direct light. You may store the unopened vials at room temperature for up to 3 months.
• If you mix the medicine and can't give your shot right away, put the syringe or vial in the refrigerator for up to 3 hours. Do not freeze it.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding, or if you have liver disease, anemia, a bleeding disorder, heart failure, or a history of seizures, depression, or thoughts of suicide. Tell your doctor if you have a latex allergy.
• This medicine may cause the following problems:
  • Liver problems
  • Congestive heart failure
  • Depression or suicidal thoughts
  • Injection site reactions, including serious skin infection or damage (necrosis)
  • Pulmonary arterial hypertension (high blood pressure in the lungs)
  • Seizures
  • Lupus
• This medicine is made from donated human blood. All donated blood is tested for certain viruses. Although your risk for getting a virus from the medicine is very low, talk with your doctor if you have concerns.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Depression, thoughts of hurting yourself, unusual moods or behaviors
• Fever, chills, cough, sore throat, body aches, swollen or tender lymph glands
• Pain, burning, redness, swelling, or blue or black skin where the shot was given
• Rapid weight gain, swelling in your hands, ankles, or feet, trouble breathing, tiredness
• Rash, tingling, pain, paleness, or cold feeling in fingers or toes
• Seizures
• Severe or ongoing skin problem where the shot was given
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild redness, pain, or swelling where the shot is given
• Muscle pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088