Momentum - Summer 2012

Medication Guide AVONEX® (a-vuh-necks)

(interferon beta-1a)
Injection for intramuscular use

Read this Medication Guide before you start using AVONEX, and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

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. Behavioral health problems including depression, suicidal thoughts or hallucinations. 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)

2. Liver problems, or worsening of liver problems includ-
ing liver failure and death. Symptoms may include:
• nausea
• loss of appetite
• tiredness
• dark colored urine
and pale stools
During your treatment with AVONEX you will need to see
your healthcare provider regularly and have regular blood
tests to check for side effects.

3. Serious allergic reactions and skin reactions. Symptoms may include:

• 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

What is AVONEX?

AVONEX is a form of a protein called beta interferon that occurs naturally in the body. AVONEX is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis.

AVONEX will not cure your MS but may decrease the number of flare-ups of the disease and slow the occurrence of some of the physical disability that is common in people with MS. MS is a life-long disease that affects your nervous system by destroying the protective covering (myelin) that surrounds your nerve fibers.

The way AVONEX works in MS is not known.

It is not known if AVONEX is safe and effective in children.

Who should not use AVONEX?

Do not take AVONEX if you:

• are allergic to interferon beta, albumin (human), or any of the ingredients in AVONEX. See the end of this Medication Guide for a complete list of ingredients in AVONEX.

What should I tell my healthcare provider before using AVONEX?

Before taking AVONEX, tell your healthcare provider if you:

• 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
• yellowing of your skin or
the white part of your eye
• bleeding more easily than
normal
• confusion
• sleepiness
• have or had seizures (epilepsy)

• Infections. Some people who take AVONEX may get an infection. Symptoms of an infection may include: ° fever ° chills ° pain or burning with urination ° urinating often ° bloody diarrhea ° coughing up mucus • Thyroid problems. Some people taking AVONEX develop changes in their thyroid function. Symptoms of thyroid changes include: ° problems concentrating ° feeling cold or hot all the time ° weight changes (gain or loss)

° skin changes

Tell your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of AVONEX include:
• Flu-like symptoms. Most people who take AVONEX have
flu-like symptoms early during the course of therapy.
Usually, these symptoms last for a day after the injection.
You may be able to manage these flu-like symptoms by
taking over-the-counter pain and fever reducers. For
many people, these symptoms lessen or go away over
time. Symptoms may include:
° muscle aches
° fever
° tiredness
° chills
Call your doctor for medical advice about side effects. You
may report side effects to FDA at 1-800-FDA-1088.

How should I store AVONEX?

• Store AVONEX in the refrigerator at 36°F to 46°F (2°C to 8°C).

• Do not freeze AVONEX. Do not use AVONEX that has been frozen.

• Do not store AVONEX above 77°F ( 25°C).

• Keep AVONEX away from light.

• Do not use AVONEX past the expiration date.

• If you cannot refrigerate your AVONEX vials, you can store your AVONEX vials at 77°F ( 25°C) for up to 30 days. After mixing, the AVONEX solution should be used immediately, within 6 hours when stored refrigerated at 36°F to 46°F (2°C to 8°C).

• If you cannot refrigerate your AVONEX PEN and AVONEX prefilled syringes, you can store your AVONEX PEN and AVONEX prefilled syringes up to 77°F ( 25°C) for up to 7 days.

Keep AVONEX vials, prefilled syringes, pens and all other medicines out of the reach of children.

General advice about the safe and effective use of AVONEX.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AVONEX for a condition for which it was not prescribed. Do not give AVONEX to other people, even if they have the same symptoms that you have, it may harm them.

This Medication Guide summarizes the most important information about AVONEX. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about AVONEX that is written for healthcare professionals.

What are the ingredients in AVONEX?

Active ingredient: interferon beta-1a

Inactive ingredients: • Vial with freeze-dried (lyophilized) powder: albumin ( human), sodium chloride, dibasic sodium phosphate, and monobasic sodium phosphate.

• Single-Use Prefilled Syringe: sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride, polysorbate 20 in water for injection.

• Single-Use Prefilled Autoinjector Pen: sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride, polysorbate 20 in water for injection.