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Getting started with once-a-week AVONEX A step-by-step guide to self-injections with AVONEX PEN ®

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Transcript of 1 3901-01-pdf pen-injection_guide_120421_final

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Getting started with once-a-week AVONEXA step-by-step guide to self-injections with AVONEX PEN®

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For important safety information, please see page 11 and full Prescribing Information and Medication Guide. 2

Table of contents

How to store AVONEX .................................... 3

AVONEX PEN injection process

Get ready............................................... 4

Prepare AVONEX PEN .......................... 5

Inject AVONEX ...................................... 7

Dispose of AVONEX PEN ..................... 9

ecoSharps ......................................................10

Important safety information .....................11

Your guide to once-a-week treatment for relapsing MSIf you’ve never given yourself an injection before, you’re probably a little nervous about the process. Don’t worry—once you’ve trained with your healthcare provider and had a little practice, it gets a lot easier.

Using AVONEX PEN may help. AVONEX PEN is a prefilled, single-use autoinjector with a covered needle that’s half the size of the standard needle for AVONEX prefilled syringe. Plus, it lets you treat your relapsing MS with one click, once a week.

This guide is designed to make starting treatment with once-a-week AVONEX PEN as simple as possible. Make sure you read through the entire guide once before your first training session with your healthcare provider.

You should also read the Instructions for Use in the AVONEX PEN package insert 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 to your healthcare provider about your MS or your treatment.

Your healthcare provider should show you or your care partner how to prepare AVONEX PEN and how to inject it the right way before you inject for the first time. Your healthcare provider should watch you inject AVONEX the first time you use AVONEX PEN. An AVONEX ActiveNurse™ is a valuable resource who can train you and your care partner, free of charge, in the comfort of your home. To schedule a training appointment, call 1-800-456-2255 today.

If you have any questions, just give us a call at 1-800-456-2255.

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For important safety information, please see page 11 and full Prescribing Information and Medication Guide. 3

How to store AVONEX

AVONEX PEN should be kept in the refrigerator (36°F-46°F or 2°C-8°C). If refrigeration is not available, you can keep your AVONEX PEN at room temperature (up to 77°F or 25°C) for up to 7 days.

Remember to take your AVONEX out of the refrigerator about 30 minutes before injecting to allow it to reach room temperature. Don’t use an external heat source, like hot water, to warm it.

Keep AVONEX from light and do not freeze it.

Never use an AVONEX PEN that has been improperly stored or exposed to conditions other than those recommended. If you have any questions, call MS ActiveSource® at 1-800-456-2255.

Traveling with AVONEX

If you’re going to be spending time away from home, follow these tips to make traveling with AVONEX as easy as possible:

Pack the supplies that you’ll need for your injections. Consider packing your AVONEX in a small cooler or insulated bag.

AVONEX PEN should be kept in the refrigerator. Check with your hotel to see if they provide refrigerators in their rooms. Be sure to keep your AVONEX away from the cooling element or freezer compartment.

If you’re traveling by car, don’t place AVONEX on the dashboard or in the trunk, even if it’s in an insulated bag.

If you’re flying, keep AVONEX in your carry-on luggage and remember to bring a copy of your prescription. Check the most current TSA requirements for injectable medications before you fly.

If needed, AVONEX can be kept at room temperature for up to seven days.

High 46°F

Low 36°F

77°F/25°C

High 46°F

Low 36°F

77°F/25°CHigh 46°F

Low 36°F

77°F/25°C

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For important safety information, please see page 11 and full Prescribing Information and Medication Guide.

AVONEX PEN injection process

Get ready Take one AVONEX PEN out of the refrigerator about 30 minutes before you plan on injecting to allow

it to reach room temperature. Do not use external heat sources such as hot water to warm it.

Find a well-lit, clean, flat work surface like a table and collect the supplies you’ll need from your AVONEX PEN package: •1AVONEXPEN • 1alcoholwipe •1sterileneedle • 1gauzepad •1AVONEXPENcover • 1adhesivebandage

Also, make sure your sharps container is close by.

Check the expiration date printed on AVONEX PEN, the AVONEX PEN Administration Dose Pack, and the outer carton. Do not use an AVONEX PEN past the expiration date.

Wash your hands with soap and water.

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Needle cover

FoilAVONEX PEN cover

3 Always use a new AVONEX PEN and needle for each injection. Do not re-use an AVONEX PEN or needle.

3 Do not share your AVONEX PEN or needles.

3 Keep AVONEX PEN and needles out of the reach of children.

Blue activation button Tamper-evident cap

Body Injector shield (grooved area)

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For important safety information, please see page 11 and full Prescribing Information and Medication Guide. 5

AVONEX PEN injection process

Prepare AVONEX PEN

• Hold AVONEX PEN with the white tamper-evident cap (cap) pointing up.

•Checkthatthecapisintactandhasnotbeenremoved.Ifthecap has been removed or is not tightly attached, do not use it. Throw it away and get a new AVONEX PEN.

• With your other hand, grasp the cap and bend it at a 90° angle until it snaps off.

•Afterthecapcomesoff,you’llseetheglasstipofthesyringe. Do not touch the glass tip of the syringe.

• Place AVONEX PEN down on a flat work surface.

• Pull off the sterile foil from the needle cover.

•OnlyusetheneedlethatcomeswithyourAVONEXPEN.

• Hold AVONEX PEN with the glass syringe tip pointing up. Press the needle onto the AVONEX PEN glass syringe tip and gently turn the needle clockwise until it is firmly attached.

•Iftheneedleisnotfirmlyattached,itmayleak,andyoumaynotget your full dose of AVONEX.

•Donot remove the plastic cover from the needle.

BEFORE AFTER (glass syringe tip)

BEFORE AFTER (attached needle)

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For important safety information, please see page 11 and full Prescribing Information and Medication Guide.

AVONEX PEN injection process

Prepare AVONEX PEN (cont’d)

• Hold the body of AVONEX PEN in one hand with the needle and needle cover pointing away from you and other people. Do not remove the plastic cover from the needle.

• Using your other hand, hold onto the grooved injector shield tightly. Quickly pull up on the injector shield until it covers the needle all the way.

•Theplasticneedlecoverwillpopoffaftertheinjectorshieldhasbeenfullyextended.

•Whentheinjectorshieldisextendedcorrectly,you’llseethesafetylock(asmallblue rectangular area next to the oval medication display window).

• Check the oval medication display window and make sure the liquid is clear and colorless.

•Youmightseeairbubblesintheliquid.ThisisnormalandwillnotaffectyourdoseofAVONEX.

• Do not use AVONEX PEN if the liquid is colored, cloudy, or contains any lumps or particles. Throw away that AVONEX PEN and start over with a new one.

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BEFORE

AFTER (extended) Safety Lock

(visible)

Oval Medication Display Window

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AVONEX PEN injection process

Inject AVONEXYour healthcare provider or ActiveNurse should show you or your care partner how to prepare AVONEX PEN and how to inject it the right way before you inject for the first time. Your healthcare provider or ActiveNurse should watch you inject AVONEX the first time you use AVONEX PEN. Inject your AVONEX PEN exactly as your healthcare provider or ActiveNurse has shown you.

• AVONEX PEN should be injected into the muscle of your upper, outer thigh. Within this area there are several potential injection sites.

•Use a different injection site each week. Do not use the same injection site for each injection.

•Donot inject into an area of the body where the skin is irritated, reddened, bruised, infected, or scarred in any way.

•Donot push down on the injector shield and the blue activation button at the same time until you’re ready to give your injection.

• Choose an injection site and wipe the skin with an alcohol wipe. Let the injection site dry before injecting the dose.

•Donot touch this area again before giving the injection.

• Place AVONEX PEN on the injection site. Hold the body of AVONEX PEN at a 90º angle to the injection site, and make sure you can see the windows.

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For important safety information, please see page 11 and full Prescribing Information and Medication Guide.

High 46°F

Low 36°F

77°F/25°C

10 sec

AVONEX PEN injection process

Inject AVONEX (cont’d)• Keeping your fingers away from the blue activation button, firmly push the body

of AVONEX PEN down against your thigh to release the safety lock. Do not lift AVONEX PEN off of the injection site.

•Check to make sure the safety lock has been released. You’ll know the safety lock is released when the small blue rectangular area above the oval medication display window is gone.

• Continue to firmly maintain pressure and push AVONEX PEN down against the injection site, then push down on the blue activation button with your thumb. Keep AVONEX PEN pushed down against the injection site and slowly count to 10.

•Youwillhearaclickwhentheinjectionstarts. If you do not hear a click, your injection was not given correctly.

•Ifyoudon’thearaclick,makesurethattheinjectorshieldisextended,thesafetylockis completely released, and that you’re firmly maintaining pressure and pushing down against the injection site. Press the blue activation button with your thumb again. If you still don’t hear a click, call 1-800-456-2255.

• After you count to 10, pull AVONEX PEN straight out of the skin. Apply pressure to the injection site with the gauze pad for a few seconds or rub the site gently in a circular motion.

•If you see blood after you press the injection site for a few seconds, wipe it off with gauze and apply an adhesive bandage.

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Safety Lock(visible)

Safety Lock(released)

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AVONEX PEN injection process

Dispose of AVONEX PEN

• Check the circular display window on AVONEX PEN to make sure that it’s yellow. This is to be sure that you have been given your full dose.

•If you didn’t receive your full dose of AVONEX, throw away that AVONEX PEN and call your doctor. Do not re-use that AVONEX PEN.

• Do not hold the AVONEX PEN cover with your hands. Place the AVONEX PEN cover on a flat work surface. Line up the exposed needle with the hole of the AVONEX PEN cover, and insert the needle directly into the opening.

• Firmly press AVONEX PEN down until you hear a click to seal the needle. You may need to hold both hands around the AVONEX PEN body to snap the AVONEX PEN cover into place.

• Throw away used AVONEX PENs and needles in a sharps container or some type of hard plastic or metal container with a screw cap, such as a detergent bottle or coffee can.

•Checkwithyourhealthcareproviderabouttherightwaytothrowawaythecontainer.There may be local or state laws about how to throw away used AVONEX PENs and needles.

•Do not throw away used AVONEX PENs and needles in household trash or recycling bins.

•After two hours, check the 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 doctor or nurse.

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“Click”

Circular Display Window

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ecoSharps™

Easy on you. Easy on the environment.Now there’s a simple and environmentally friendly way to make sure your AVONEX PENs don’t end up in a landfill.

When you enroll in ecoSharps, we’ll send you a free sharps container. When the container is full, just mail it back to us in the prepaid box provided, and we’ll send you a replacement container.

What happens to your used AVONEX PENs? They’ll be sterilized and broken down into a raw material that can be used in construction materials. You can feel comfortable knowing that you’ve safely disposed of your AVONEX PENs.

Visit AVONEXecoSharps.com or call 1-800-456-2255 to enroll in ecoSharps. We’ll take care of the rest.

ecoSharps™

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IndicationAVONEX® (interferon beta-1a) is approved by FDA to treat relapsing forms of multiple sclerosis (MS) to decrease the number of flare-ups and slow the occurrence of some of the physical disability that is common in people with MS. AVONEX is approved for use in people who have experienced a first attack and have lesions consistent with MS on their MRI.

Important Safety InformationBefore beginning treatment, you should discuss with your healthcare provider the potential benefits and risks associated with 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.

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, and hearing or seeing things that others do not hear or see (hallucinations).

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, and 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.

Serious allergic reactions and skin reactions. Symptoms may include itching, swelling of the face, eyes, lips, tongue or throat, trouble breathing, anxiousness, feeling faint, and skin rash, hives, sores in your mouth, or your skin blisters and peels.

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.

Do not take AVONEX if you are allergic to interferon beta, albumin (human), or any of the ingredients in 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

Indication and Important Safety Information

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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.

AVONEX can cause serious side effects including: 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, and heart attack or 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, and 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, and 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, and chills.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information and Medication Guide on AVONEX.com for additional important safety information. This information is not intended to replace discussions with your healthcare provider.

Indication and Important Safety Information (cont’d)

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AVONEX, MS ACTIVESOURCE, BIOGEN IDEC, and their respective logos are registered trademarks of Biogen Idec. AVONEX PEN is a registered trademark of Biogen Idec. ECOSHARPS and MS ACTIVESOURCE are sponsored by Biogen Idec. ECOSHARPS, ACTIVENURSES, and their respective logos are trademarks of Biogen Idec.

© 2013 Biogen Idec. All rights reserved. Printed in U.S.A. 05/13 AVX-1001882

With you, every step of the wayIf the injection process seems overwhelming, remember—you’re not alone.

Now that you’ve read through this guide, call 1-800-456-2255. You can schedule one-on-one training with an ActiveNurse, get answers

to your questions about AVONEX, and more. We’re here to help.