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 including liver failure and death. Symptoms may include:

   nausea loss of appetite tiredness dark colored urine and pale stools

   yellowing of your skin or the white part of your eye bleeding more easily than normal confusion sleepiness

   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
• 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), such as psoriasis, systemic lupus erythematosus, or rheumatoid arthritis
• drink alcohol
• are pregnant or plan to become pregnant. It is not known if AVONEX will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with AVONEX.
• are breastfeeding or plan to breastfeed. It is not known if AVONEX passes into your breast milk. You and your healthcare provider should decide if you will use AVONEX or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

How should I use AVONEX?

• Your healthcare provider should show you how to prepare and measure your dose of AVONEX and how to inject your AVONEX before you use AVONEX for the first time.
• Your healthcare provider or nurse should watch the first AVONEX injection you give yourself.
• AVONEX is given once a 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:
  • Vial with freeze-dried (lyophilized) powder
  • Prefilled syringe (can be used with the AVOSTARTGRIP™ titration kit)
  • Single-Use Prefilled Autoinjector Pen (AVONEX® PEN™)

Your healthcare provider will decide which one is best for you. See the Instructions for Use at the end of this Medication Guide for detailed instructions for preparing and injecting your dose of AVONEX.

• Always use a new, unopened AVONEX vial, prefilled syringe, or single-use prefilled autoinjector pen for each intramuscular injection.

What are the possible side effects of AVONEX?

AVONEX can cause serious side effects including:

• See “What is the most important information I should know about AVONEX?”
• Heart problems, including heart failure. While AVONEX is not known to have any direct effects on the heart, a few patients 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.
• Seizures. Some patients have had seizures while taking AVONEX, including patients who have never had seizures before.
• 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.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:
BIOGEN IDEC INC.
14 Cambridge Center
Cambridge, MA 02142 USA
©1996-2012 Biogen Idec Inc. All rights reserved.
1-800-456-2255

Revised 02/2012

Medication Guide Appendix: Instructions for Preparing and Giving a Dose with an AVONEX® Vial

Storing AVONEX® Vials

Prior to use, AVONEX® should be refrigerated (36-46°F or 2-8°C) but can be kept for up to 30 days at room temperature (77°F or 25°C). You should avoid exposing AVONEX® to high temperatures and freezing. After mixing, AVONEX® solution should be used immediately, within 6 hours when stored refrigerated at 36-46°F or 2-8°C. Do not freeze the AVONEX® solution.

How do I prepare and inject a dose of AVONEX®?

Find a well-lit, clean, flat work surface like a table and collect all the supplies you will need to give yourself or receive an injection. You may want to take one AVONEX® Administration Dose Pack out of the refrigerator about 30 minutes before you plan on injecting your dose to allow it to reach room temperature. A room temperature solution is more comfortable to inject.

You will need the following supplies:

• vial of AVONEX® (white to off-white powder or cake)
• vial of diluent, single-use (Sterile Water for Injection, USP)
• 3 mL syringe
• blue MICRO PIN® (vial access pin)
• sterile needle
• alcohol wipes
• gauze pad
• adhesive bandage
• a puncture resistant container for disposal of used syringes, needles, and MICRO PINS.

Preparing the AVONEX® solution

It is important to keep your work area, your hands, and your injection site clean to minimize risk of infection. You should wash your hands prior to preparing the medication.

1. Check the expiration date on the AVONEX® vial and the vial of diluent; do not use if the medication or diluent is expired.
2. Remove the caps from the vial of AVONEX® and the vial of diluent, and clean the rubber stopper on the top of each vial with an alcohol wipe.

   

3. Attach the blue MICRO PIN® to the syringe by turning clockwise until secure. NOTE: Over-tightening can make the MICRO PIN® difficult to remove.

   

4. Pull the MICRO PIN® cover straight off; do not twist. Save the cover for later use.

   

5. Pull back the syringe plunger to the 1.1 mL mark.

   

6. Firmly push the MICRO PIN® down through the center of the rubber stopper of the diluent vial.

   

7. Inject the air in the syringe into the diluent vial by pushing down on the plunger until it cannot be pushed any further.
8. Keeping the MICRO PIN® in the vial, turn the diluent vial and syringe upside down.
9. While keeping the MICRO PIN® in the fluid, slowly pull back on the plunger to withdraw 1.1 mL of diluent into the syringe.

   

10. Gently tap the syringe with your finger to make any air bubbles rise to the top. If bubbles are present, slowly press the plunger in (to push just the bubbles out through the needle). Make sure there is still 1.1 mL of diluent in the syringe.

    

11. Slowly pull the MICRO PIN® out of the diluent vial.
12. Carefully insert the MICRO PIN® through the center of the rubber stopper of the vial of AVONEX®. NOTE: Off-center punctures can push the stopper into the vial. If the stopper falls into the vial, do not use.
13. Slowly inject the diluent into the vial of AVONEX®. DO NOT aim the stream of diluent directly on the AVONEX® powder. Too direct or forceful a stream of diluent onto the powder may cause foaming, and make it difficult to withdraw AVONEX®.

    

14. Without removing the syringe, gently swirl the vial until the AVONEX® is dissolved. DO NOT SHAKE.

    

15. Check to see that all of the AVONEX® is dissolved. Check the solution in the vial of AVONEX®. It should be clear to slightly yellow in color and should not have any particles. Do not use the vial if the solution is cloudy, has particles in it or is a color other than clear to slightly yellow.
16. Turn the vial and syringe upside down. Slowly pull back on the plunger to withdraw 1.0 mL of AVONEX®. If bubbles appear, push solution slowly back into the vial and withdraw the solution again.

    

17. With the vial still upside down, tap the syringe gently to make any air bubbles rise to the top. Then press the plunger in until the AVONEX® is at the top of the syringe. Check the volume (should be 1.0 mL) and withdraw more medication if necessary. Withdraw the MICRO PIN® and syringe from the vial.
18. Replace the cover on the MICRO PIN® and remove from the syringe with a counterclockwise turn.
19. Attach the sterile needle for injection to the syringe turning clockwise until the needle is secure. A secure attachment will prevent leakage during the injection.

    

Selecting an injection site

You should use a different site each time you inject. This can be as simple as switching between thighs (if you are always injecting yourself), or if another person is helping you, you can rotate between your upper arms and your thighs. Keeping a record of the date and location of each injection will help you.

Do not inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way. The best sites for intramuscular injection are the thigh and upper arm:

• thigh

  

• upper arm

  

Injecting the AVONEX® dose

1. Use a new alcohol wipe to clean the skin at one of the recommended intramuscular injection sites. Then, pull the protective cover straight off the needle; do not twist the cover off.
2. With one hand, stretch the skin out around the injection site. Hold the syringe like a pencil with the other hand, and using a quick motion insert the needle at a 90° angle, through the skin and into the muscle.
3. Once the needle is in, let go of the skin and use that hand to gently pull back slightly on the plunger. If you see blood come into the syringe, withdraw the needle from the injection site and put pressure on the site with a gauze pad. You will need to replace the needle and choose and clean a new site for injection.
4. If no blood came into the syringe, slowly push the plunger in until the syringe is empty.

   

5. Hold a gauze pad near the needle at the injection site and pull the needle straight out. Use the pad to apply pressure to the site for a few seconds or rub gently in a circular motion.

   

6. If there is bleeding at the site, wipe it off and, if necessary, apply an adhesive bandage.
7. Dispose of the used syringe, needle and blue MICRO PIN® in your puncture resistant container. DO NOT USE a syringe, MICRO PIN®, or needle more than once. The AVONEX® and diluent vials should be put in the trash.

Disposal of syringes and needles

There may be special state and/or local laws for disposing of used needles and syringes. Your doctor, nurse or pharmacist should provide you with instructions on how to dispose of your used needles and syringes.

• Always keep your disposal container out of the reach of children.
• DO NOT throw used needles and syringes into the household trash and DO NOT RECYCLE.

Manufactured by:
Biogen Idec Inc.
14 Cambridge Center
Cambridge, MA 02142 USA
©1996-2011 Biogen Idec Inc. All rights reserved.
1-800-456-2255

Appendix Revision Date: 11/2004

I63005-11

*Micro Pin® is the trademark of B. Braun Medical Inc.