What is the most important information I should know about AVONEX?
AVONEX can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking AVONEX.
1. Depression, suicidal thoughts, hallucinations or other behavioral health problems. Some people taking AVONEX may develop mood or behavior problems including:

• irritability (getting upset easily)
• depression (feeling hopeless or feeling bad about yourself)
• nervousness
• anxiety
• aggressive behavior
• thoughts of hurting yourself or suicide
• hearing or seeing things that others do not hear or see (hallucinations)

• itching
• swelling of the face, eyes, lips, tongue or throat
• trouble breathing
• anxiousness
• feeling faint
• skin rash, hives, sores in your mouth, or your skin blisters and peels

• are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior.
• have or had bleeding problems or blood clots.
• have or had low blood cell counts.
• have or had liver problems.
• have or had seizures. (epilepsy).
• have or had heart problems.
• have or had thyroid problems.
• have or had any kind of autoimmune disease (where the body's immune system attacks the body's own cells).
• drink alcohol.
• have or have had an allergic reaction to rubber or latex. The tip cap of the AVONEX prefilled syringe and prefilled autoinjector Pen contain natural rubber latex.
• are pregnant or plan to become pregnant. It is not known if AVONEX can harm your unborn baby.
• are breastfeeding or plan to breastfeed. AVONEX may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take AVONEX.

• See the Instructions for Use for detailed instructions for preparing and injecting your dose of AVONEX.
• A healthcare provider should show you how to prepare your dose of AVONEX and how to inject your AVONEX before you use it for the first time.
• A healthcare provider or nurse should watch the first AVONEX injection you give yourself.
• AVONEX is given 1 time each week by injection into the muscle (intramuscular injection).
• Inject AVONEX exactly as your healthcare provider tells you.
• Your healthcare provider will tell you how much AVONEX to inject and how often to inject AVONEX. Do not inject more than your healthcare provider tells you to.
• Do not change your dose unless your healthcare provider tells you to.
• Change (rotate) your injection site you choose with each injection. This will help decrease the chance that you will have an injection site reaction.
• Do not inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way.
• AVONEX comes as a:
  • Single-dose prefilled syringe (can be used with the AVOSTARTGRIP™ titration kit)
  • Single-dose prefilled autoinjector Pen (AVONEX PEN®)
• After 2 hours check your injection site for redness, swelling or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your healthcare provider.
  

• See “What is the most important information I should know about AVONEX?”
• Injection site reactions. AVONEX may cause redness, pain, itching, or swelling at the place where your injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider.
• Heart problems, including heart failure. Some people who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking AVONEX. If you already have heart failure, AVONEX may cause your heart failure to get worse. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using AVONEX.
  • Some people using AVONEX may have other heart problems including:
    • low blood pressure
    • fast or abnormal heart beat
    • chest pain
    • heart attack or a heart muscle problem (cardiomyopathy)
• Blood problems. AVONEX can affect your bone marrow and cause low red and white blood cell, and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising.
• Thrombotic microangiopathy (TMA). TMA is a condition that involves injury to the smallest blood vessels in your body. TMA can also cause injury to your red blood cells (the cells that carry oxygen to your organs and tissues) and your platelets (cells that help your blood clot) and can sometimes lead to death. Your healthcare provider may tell you to stop taking AVONEX if you develop TMA.
• Pulmonary arterial hypertension. Pulmonary arterial hypertension can occur with interferon beta products, including AVONEX. Symptoms may include new or increasing fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms.
• Seizures. Some people have had seizures while taking AVONEX, including people who have never had seizures before. Tell your healthcare provider right away if you have a seizure.
• Autoimmune diseases. Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use AVONEX.
  
  

• Flu-like symptoms. Most people who take AVONEX have flu-like symptoms especially early during the course of therapy. Usually, these symptoms last for a day after the injection. Symptoms may include:
  • muscle aches
  • fever
  • tiredness
  • chills
    

• Single-Dose Prefilled Syringe: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for inject]tion.
• Single-Dose Prefilled Autoinjector Pen: arginine hydrochloride, glacial acetic acid, polysorbate 20, sodium acetate trihydrate in water for injection.