Betaseron Solution

Betaseron Solution is used for:

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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.

Betaseron Solution is a protein identical to one found in the body. How Betaseron Solution works is not fully understood. It is thought to interfere with other chemicals in the body that cause flare-ups of MS.

Do NOT use Betaseron Solution if:

• you are allergic to any ingredient in Betaseron Solution

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

Before using Betaseron Solution:

Some medical conditions may interact with Betaseron 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, thyroid problems, blood problems (eg, anemia), bone marrow depression, seizures, mood or mental problems, or suicidal thoughts or behaviors

Some MEDICINES MAY INTERACT with Betaseron Solution. However, no specific interactions with Betaseron Solution are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Betaseron 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 Betaseron Solution:

Use Betaseron Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Betaseron Solution comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Betaseron Solution refilled.
• Betaseron Solution is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Betaseron Solution at home, carefully follow the injection procedures taught to you by your health care provider.
• If Betaseron Solution contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• 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 Betaseron Solution.
• 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. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Betaseron Solution, use it as soon as possible. However, your next injection should be scheduled about 48 hours later. Do not use Betaseron Solution on 2 consecutive days. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Betaseron Solution.

Important safety information:

• Betaseron Solution may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Betaseron Solution. Using Betaseron Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Some patients become depressed or suicidal while taking Betaseron Solution. If you begin to feel depressed or suicidal, contact your doctor.
• Betaseron Solution commonly causes flu-like symptoms (eg, fever, chills, tiredness, muscle aches). Talk to your doctor about whether you should take a nonprescription medicine for pain or fever reduction before or after taking Betaseron Solution.
• Betaseron Solution may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• Betaseron Solution may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
• Betaseron Solution CONTAINS ALBUMIN, which comes from human blood. There is an extremely rare risk of developing a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease. No cases of viral disease or Creutzfeldt-Jakob disease from albumin have been identified.
• LAB TESTS, including blood cell counts, liver function tests, and thyroid function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Betaseron Solution with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Betaseron Solution may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Betaseron Solution during pregnancy. It is unknown if Betaseron Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Betaseron Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Betaseron 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:

Constipation;changes in menstrual cycle; diarrhea; dizziness; drowsiness; flu-like symptoms (eg, low-grade fever, chills, general body discomfort); frequent urination; headache; joint pain; muscle pain or weakness; nausea; redness, pain, or swelling at the injection site; stomach upset; sweating; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue-black discoloration or skin breakdown around the injection site; chest pain; confusion; fast or irregular heartbeat; feeling cold or hot all the time; infection; mood or mental changes (eg, depression); persistent or high fever; seizures; severe anxiety or nervousness; severe headache or dizziness; severe stomach pain; suicidal thoughts or behaviors; unexplained swelling or weight gain; unusual bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately.

Store Betaseron Solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. After mixing, the medicine may be stored in the refrigerator, but should be used within 3 hours after mixing. Do not freeze. Keep Betaseron 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 Betaseron Solution, please talk with your doctor, pharmacist, or other health care provider.
• Betaseron 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.

This information is a summary only. It does not contain all information about Betaseron Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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