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Interferon beta-1b solution

Generic Name: interferon beta-1b (IN-ter-FEER-on BAY-ta)
Brand Name: Examples include Betaseron and Extavia

Interferon beta-1b solution is used for:

Treating relapsing forms of multiple sclerosis (MS) to reduce the number of flare-ups and slow down the development of physical disability associated with MS.

Interferon beta-1b solution is a protein similar to one found in the body. Exactly how it works is not known.

Do NOT use interferon beta-1b solution if:

  • you are allergic to any ingredient in interferon beta-1b solution, to another interferon beta, to albumin products, or to mannitol
  • you are using another medicine that contains interferon beta-1b

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using interferon beta-1b solution:

Some medical conditions may interact with interferon beta-1b solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems, heart problems (eg, heart failure), thyroid problems, blood or bone marrow problems (eg, anemia, easy bleeding or bruising, low white blood cell levels), seizures, mood or mental problems (eg, depression), or suicidal thoughts or behaviors
  • if you have a history of trouble sleeping
  • if you drink alcohol

Some MEDICINES MAY INTERACT with interferon beta-1b solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Telbivudine because the risk of its side effects may be increased by interferon beta-1b solution
  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if interferon beta-1b solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use interferon beta-1b solution:

Use interferon beta-1b solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Interferon beta-1b solution comes with an extra patient information sheet called a Medication Guide. It also comes with detailed instructions for use. Read them carefully. Read them again each time you get interferon beta-1b solution refilled.
  • Interferon beta-1b solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using interferon beta-1b solution at home, a health care provider will teach you how to use it. Be sure you understand how to use interferon beta-1b solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Interferon beta-1b solution must be mixed before using it. Gently swirl interferon beta-1b solution to mix it. Do NOT shake interferon beta-1b solution. Shaking and even gentle mixing can cause foaming of the medicine. If there is foam, let the vial sit until the foam settles before using it.
  • Do not use interferon beta-1b solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle or a vein.
  • Rotate injection sites. Do not inject into an area of the body where the skin is irritated, red, bruised, infected, or scarred in any way. If you experience a break in the skin, blue-black discoloration of the skin, or fluid drainage from the injection site, contact your health care provider at once before continuing use of interferon beta-1b solution.
  • Use a new, unopened vial of interferon beta-1b solution and syringe for each injection. Throw away any unused medicine.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of interferon beta-1b solution, use it as soon as possible. Then use your next dose about 48 hours later. Do not use interferon beta-1b solution 2 days in a row. Do not use 2 doses at once. Check with your doctor if you are unsure what to do if you miss a dose.

Ask your health care provider any questions you may have about how to use interferon beta-1b solution.

Important safety information:

  • Do not change your dose of interferon beta-1b solution without checking with your doctor.
  • Some patients become depressed or suicidal while taking interferon beta-1b solution. If you begin to feel depressed or suicidal, contact your doctor.
  • Interferon beta-1b solution commonly causes flu-like symptoms (eg, fever, chills, sweating, tiredness, muscle aches). Talk to your doctor about whether you should take a nonprescription medicine for pain or fever reduction before or after taking interferon beta-1b solution.
  • Interferon beta-1b solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Interferon beta-1b solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Interferon beta-1b solution is not a cure for MS. Remain under the care of your doctor.
  • Interferon beta-1b solution contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used interferon beta-1b solution.
  • Lab tests, including complete blood cell counts, liver function, and thyroid function, may be performed while you use interferon beta-1b solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Interferon beta-1b solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Interferon beta-1b solution may cause harm to the fetus. It may cause you to miscarry. If you think you may be pregnant, contact your doctor right away. It is not known if interferon beta-1b solution is found in breast milk. Do not breast-feed while taking interferon beta-1b solution.

Possible side effects of interferon beta-1b solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Decreased sexual ability; flu-like symptoms (eg, low-grade fever, general body discomfort, unusual sweating); frequent urination; headache; mild pain, swelling, or redness at the injection site; mild stomach pain; muscle pain or weakness; nausea; trouble sleeping; unusual spotting or menstrual bleeding; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue-black skin discoloration, skin breakdown, oozing, or persistent pain or swelling around the injection site; chest pain; decreased coordination; fast or irregular heartbeat; feeling cold or hot all the time; muscle stiffness; new or worsening mental, mood, or behavior changes (eg, depression, anxiety, hallucinations, nervousness); persistent trouble sleeping; seizures; severe or persistent headache or dizziness; shortness of breath; suicidal thoughts or behaviors; swelling of the hands, ankles, or feet; swollen lymph nodes; symptoms of infection (eg, severe or persistent fever, chills, sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, unusual nausea or vomiting, right-sided stomach pain, loss of appetite, unusual tiredness); unusual bruising or bleeding; unusual weight gain or loss.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of interferon beta-1b solution:

Store interferon beta-1b solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Interferon beta-1b solution may be stored at temperatures between 59 and 86 degrees F (15 and 30 degrees C) for up to 3 months. After mixing, the medicine may be stored in the refrigerator but should be used within 3 hours after mixing. Do not freeze. Keep interferon beta-1b solution, as well as needles and syringes, out of the reach of children and away from pets.

General information:

  • If you have any questions about interferon beta-1b solution, please talk with your doctor, pharmacist, or other health care provider.
  • Interferon beta-1b solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take interferon beta-1b solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about interferon beta-1b solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to interferon beta-1b solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using interferon beta-1b solution.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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