The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Generic Name: interferon beta-1a (IN-ter-FEER-on BAY-ta)
Brand Name: Avonex
Avonex vials are used for:
Treating relapsing forms of multiple sclerosis (MS) in certain patients to reduce the number of flare-ups and to slow down the development of physical disability associated with MS.
Avonex vials are a protein identical to one found in the body. Exactly how it works is not known. It is thought to interfere with certain substances in the body that cause flare-ups of MS.
Do NOT use Avonex vials if:
- you are allergic to any ingredient in Avonex vials, to another interferon beta medicine, or to albumin
Contact your doctor or health care provider right away if any of these apply to you.
Before using Avonex vials:
Some medical conditions may interact with Avonex vials. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other interferon medicine (eg, interferon alfa)
- if you have a history of liver problems or abnormal liver function tests, an autoimmune disease (eg, psoriasis, lupus, rheumatoid arthritis), bleeding problems, blood clots, thyroid problems, low blood cell counts (eg, red or white blood cells, platelets), heart problems (eg, heart failure), or seizures
- if you have a history of mental or mood problems (eg, depression), suicidal thoughts or behaviors, or alcohol abuse or dependence
- if you drink alcohol
Some MEDICINES MAY INTERACT with Avonex vials. 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 Avonex vials
- 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 Avonex vials 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 Avonex vials:
Use Avonex vials as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Avonex vials comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Avonex vials refilled.
- Avonex vials also comes with an additional patient leaflet with detailed instructions for use. Talk to your pharmacist if you have questions about this information.
- Avonex vials are usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Avonex vials at home, a health care provider will teach you how to use it. Be sure you understand how to use Avonex vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Avonex vials if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Use Avonex vials right away after mixing. It may be used for up to 6 hours after mixing if stored in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze.
- Avonex vials are for injection into a muscle. Use the proper technique taught to you by your doctor.
- Do not inject Avonex vials into an area where the skin is irritated, reddened, bruised, infected, or scarred.
- Be sure to rotate your injection site with each injection to avoid an injection site reaction.
- 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 Avonex vials, use it as soon as possible and skip your dose the following day. Do not take Avonex vials on 2 consecutive days. Return to your regular dosing schedule the following week. If you accidentally take Avonex vials on 2 consecutive days or take more than your prescribed dose, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Avonex vials.
Important safety information:
- Avonex vials may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Avonex vials with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not change your dose of Avonex vials or use more often than prescribed without checking with your doctor.
- Mental or mood problems (eg, depression) and suicidal thoughts or behaviors have been reported in patients taking Avonex vials. Contact your doctor right away if you experience new or worsening mental or mood problems (eg, aggression, anxiety, depression, hallucinations, irritability, nervousness) or suicidal thoughts or behaviors.
- Avonex vials may cause an injection site reaction, such as redness, swelling, or tenderness. Check your injection site 2 hours after you use Avonex vials. If you have a skin reaction and it does not go away in a few days, contact your doctor or nurse.
- Severe liver problems, including cases of liver failure and death, have been reported rarely in patients taking Avonex vials. Your risk of liver problems may be greater if you drink alcohol while you are using Avonex vials. Talk to your doctor before drinking alcohol while you are using Avonex vials.
- Avonex vials commonly causes flu-like symptoms. Talk to your doctor about whether you should take a nonprescription medicine for pain or fever reduction before or after taking Avonex vials.
- Avonex vials 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.
- Avonex vials 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.
- Avonex vials are not a cure for MS. Remain under the care of your doctor.
- Avonex vials 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 Avonex vials.
- Lab tests, including complete blood cell counts, liver function tests, and thyroid function tests, may be performed while you use Avonex vials. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Avonex vials should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Avonex vials while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Avonex vials, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Avonex vials:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; flu-like symptoms (eg, headache, tiredness, mild fever or chills, muscle aches, weakness); joint pain; mild stomach pain; nausea; pain, redness, swelling, or tenderness at the injection site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; mouth sores; blistered or peeling skin); change in vision; chest, jaw, or arm pain; confusion; fainting; fast or irregular heartbeat; new or worsening mental or mood problems (eg, aggression, anxiety, depression, hallucinations, irritability, nervousness); seizures; severe or persistent dizziness or light-headedness; severe or persistent pain, redness, swelling, or tenderness at the injection site; shortness of breath; sudden unexplained weight gain; suicidal thoughts or behaviors; swelling of the hands, ankles, legs, or feet; symptoms of infection (eg, fever; chills; persistent sore throat; painful, burning, or increased urination; bloody diarrhea; coughing up mucus); symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; severe stomach pain; unusual nausea, drowsiness, or tiredness; yellowing of the eyes or skin); symptoms of thyroid problems (eg, trouble concentrating, feeling cold or hot all the time, weight changes, skin changes); unusual bruising or bleeding; unusual tiredness or weakness.
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 Avonex vials:
Store Avonex vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If refrigeration is not available, Avonex vials can be stored at or below 77 degrees F (25 degrees C) for up to 30 days. Store away from heat, moisture, and light. Keep Avonex vials, as well as needles and syringes, out of the reach of children and away from pets.
- If you have any questions about Avonex vials, please talk with your doctor, pharmacist, or other health care provider.
- Avonex vials are 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 Avonex vials 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 Avonex vials. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Avonex vials. 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 Avonex vials.