Betaseron SolutionGeneric Name: Interferon Beta-1b
(IN-ter-FEER-on BAY-ta)Brand Name:
Betaseron 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.
Betaseron Solution is a protein similar to one found in the body. Exactly how it works is not known.
Do NOT use Betaseron Solution if:
- you are allergic to any ingredient in Betaseron Solution, including albumin
- 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.
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, easy bleeding or bruising), bone marrow problems, seizures, mood or mental problems (eg, depression), or suicidal thoughts or behaviors
Some MEDICINES MAY INTERACT with Betaseron Solution. However, no specific interactions with Betaseron Solution are known at this time.
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.
- An extra patient leaflet is available with Betaseron Solution. Talk to your pharmacist if you have questions about this information.
- Betaseron Solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Betaseron Solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Betaseron Solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Betaseron Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- 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 Betaseron Solution.
- Keep this product, as well as syringes and needles, out of the reach of children and 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 Betaseron Solution, use it as soon as possible. Then use your next dose about 48 hours later. Do not use Betaseron 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 Betaseron Solution.
Important safety information:
- 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, 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 Betaseron Solution.
- Betaseron 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.
- Betaseron 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.
- Betaseron 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 Betaseron Solution.
- Lab tests, including complete blood cell counts, liver function, and thyroid function, may be performed while you use Betaseron Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Betaseron Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Betaseron Solution if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Betaseron Solution is found in breast milk. If you are or will be breast-feeding while you use Betaseron Solution, check with your doctor. Discuss any possible 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:
Decreased sexual ability; flu-like symptoms (eg, low-grade fever, chills, general body discomfort; unusual sweating); frequent urination; headache; joint pain; mild pain, swelling, or redness at the injection site; muscle pain or weakness; nausea; stomach upset; 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 discoloration, skin breakdown, oozing, or persistent pain or swelling around the injection site; chest pain; decreased coordination; feeling cold or hot all the time; mood or mental changes (eg, depression, anxiety, nervousness, severe or persistent trouble sleeping); muscle stiffness; 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, right-sided stomach pain); 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.Proper storage of Betaseron Solution:
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.
- 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.
- Betaseron Prescribing Information (FDA)
- Betaseron Consumer Overview
- Betaseron Advanced Consumer (Micromedex) - Includes Dosage Information
- Interferon Beta-1b Professional Patient Advice (Wolters Kluwer)
- Extavia Prescribing Information (FDA)
- Extavia Consumer Overview