Getting ready to take your shot · your shot For Important Safety Information, please see pages...

A step-by-step Injection Training Guide for the PLEGRIDY Pen and prefilled syringe

to takeGetting ready

your shot

For Important Safety Information, please see pages 50-51. Please review the enclosed full Prescribing Information, Medication Guide and Instructions for Use provided in this guide.


Questions? You can call us any time at 1.800.456.2255.

3

Welcome to PLEGRIDY®

The only interferon beta for relapsing MS you inject once every 2 weeks

We know that relapsing multiple sclerosis (MS) is a journey, and it’s not one you should take alone. Biogen—along with your healthcare team, care partner, and loved ones—is here for you.

This Injection Training Guide is designed to help you feel comfortable with the PLEGRIDY® (peginterferon beta-1a) injection technique. It provides detailed instructions and the do’s and don’t’s you need to know about the dosing and administration of PLEGRIDY.

Be sure to read through this entire guide carefully before your first injection. This is important because the PLEGRIDY injection technique may be different from your previous therapy.

If an MS-trained Nurse Educator from Biogen’s Above MS™ program is coming to your home to provide additional injection training, please keep this guide handy so you can go through it together.

You may be planning to begin treatment without the help of an Above MS Nurse Educator. If so, you can always change your mind later and decide to have an in-home visit, as needed.

Either way, you may have questions after you start your treatment. You should always reach out to your doctor with questions, as he or she will be your primary resource. Our Above MS team is always here as well, to answer any questions you may have. You can speak with a Nurse Educator 24 hours a day, 7 days a week.

The Above MS team will do everything they can to help make your experience with PLEGRIDY as smooth as possible throughout your journey.

Visit InjectingPLEGRIDY.com to view an online video about injecting with the PLEGRIDY Pen.

Please see additional dosing information on titration, administration instructions, and premedication for flu-like symptoms on page 51.


4

Table of contentsAbove MS™ Support Services ....................................................................................................................6

PLEGRIDY PenAbout the PLEGRIDY Pen and Starter Pack ........................................................................................ 9-10Getting started ......................................................................................................................................11-12To help you prepare .................................................................................................................................. 13Important things to know ..........................................................................................................................14Taking your shot ........................................................................................................................................ 15 Preparing for your injection ................................................................................................................ 17 Choosing your injection site ...............................................................................................................19 Giving your injection .....................................................................................................................22-24 After your injection ...................................................................................................................... 25-26 Storing PLEGRIDY® .................................................................................................................................. 27

PLEGRIDY prefilled syringeAbout the PLEGRIDY prefilled syringe and Starter Pack ................................................................... 31-32Getting started ................................................................................................................................... 33-34To help you prepare ................................................................................................................................. 35Important things to know ......................................................................................................................... 36Taking your shot ........................................................................................................................................37 Preparing for your injection ...................................................................................................................... 39 Choosing your injection site ...............................................................................................................41 Giving your injection .................................................................................................................... 43-45 After your injection ..............................................................................................................................47-48 Storing PLEGRIDY® ........................................................................................................................... 48

Indication and Important Safety Information. ..............................................................50-51

For Important Safety Information, please see pages 50-51. Please review the enclosed full Prescribing Information, Medication Guide and Instructions for Use provided in this guide.For Important Safety Information, please see pages 50-51. Please review the enclosed full Prescribing Information, Medication Guide and Instructions for Use provided in this guide.

5

servicessupport


6

Support is here if you need itThe Above MS™ program from Biogen is here for you with tips, tools, and information for your MS—and so much more:

• Support Coordinators offer one-on-one MS support over the phone

° General MS information

° Additional injection training information

• Peer Community

° Helps you connect with others living with MS

• Financial and Insurance Support

° Insurance counseling

° Benefit investigation

° $0 Copay Program and copay assistance, if you’re eligible

• Nurse Educators

° Available by phone 24/7 to answer questions

° Supplemental injection technique support for you and your care partner

Please keep in mind that your doctor is always your primary resource when it comes to your RMS and your treatment

Join the Above MS program. Call 1.800.456.2255 to get started.


7

PLEGRIDY Penabout the


8

For Important Safety Information, please see pages 50-51. Please review the enclosed full Prescribing Information, Medication Guide and Instructions for Use provided in this guide.9

About the PLEGRIDY Pen and Starter PackRefer to these instructions if your doctor has prescribed the PLEGRIDY Pen Starter Pack. The PLEGRIDY Pen Starter Pack uses a color-coded system that lets you gradually build up to a full dose of PLEGRIDY® (peginterferon beta-1a). This helps in adjusting to the effects of PLEGRIDY.

Note: After using your orange and blue Starter Pack pens, you will transition to the gray PLEGRIDY administration dose pen (125 mcg), which you will use for each following dose. These instructions for injecting also apply to the PLEGRIDY administration dose pen.

Read the Instructions for Use before you start using PLEGRIDY and each time you get a refill. There may be new information. Please note that there is only one Instructions for Use document included in each 2-dose pack of PLEGRIDY. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Helpful hint: You might be wondering why you have to first inject using the Starter Pack. Your first injection of PLEGRIDY (orange pen) contains about half the medicine of a typical dose. Your second injection (blue pen) contains about three-quarters of a typical dose.

Talk to your doctor if you have any questions about PLEGRIDY. You can also call the Above MS™ support services team any time at 1.800.456.2255 or visit PLEGRIDY.com.

PLEGRIDY Pen


10

About the PLEGRIDY Pen and Starter Pack (cont’d)The PLEGRIDY Pen is a single-use, disposable autoinjector. It comes fully assembled, so you don’t have to attach a needle, see a needle, click a button, or push a plunger. Before you use the PLEGRIDY Pen for the first time, your healthcare provider should show you and/or your caregiver how to prepare and inject your PLEGRIDY Pen the right way. An Above MS™ Nurse Educator can also provide additional training on how to use the PLEGRIDY Pen and Starter Pack.

Read the Instructions for Use before you start using PLEGRIDY® (peginterferon beta-1a) and each time you get a refill. There may be new information. Please note that there is only one Instructions for Use document included in each 2-dose pack of PLEGRIDY. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

The PLEGRIDY Pen Starter Pack lets you gradually build up to a full dose of PLEGRIDY. It contains your first 2 injections, which gradually increase your PLEGRIDY dose. For each injection after that, use the gray administration dose pen:

For Day 1: One ORANGE pen containing 63 mcg of PLEGRIDY

For Day 15: One BLUE pen containing 94 mcg of PLEGRIDY

For Day 29: One GRAY pen containing 125 mcg of PLEGRIDY

(and every 14 days after that)


Getting started • Before you use your PLEGRIDY Pen for the first time, your healthcare provider should show you or your caregiver how

to prepare and inject your PLEGRIDY Pen the right way

• If you experience difficulty or have questions, call 1.800.456.2255

• PLEGRIDY Pen is for use under the skin only (subcutaneous)

• Each PLEGRIDY Pen can be used 1 time only. Do not share your PLEGRIDY Pen with anyone else. By sharing the pen, you may give an infection to them or get an infection from them

• Use PLEGRIDY® (peginterferon beta-1a) exactly as your healthcare provider tells you

Find a well-lit, clean, flat surface, and collect all the supplies you will need to give yourself an injection or to receive an injection from your caregiver or nurse:

Choose the correct prefilled pen from the Starter Pack:

Day 1: Choose ORANGE (63 mcg) for your first injection

Day 15: Choose BLUE (94 mcg) for your second injection

Day 29 (and every 14 days after that): Choose GRAY (125 mcg)

As a reminder, after using both pens in the Starter Pack, you will use the gray PLEGRIDY administration dose pen (125 mcg), which your doctor also prescribed for you. The gray pen will be used for your third and subsequent injections.

Pen: Getting started


12

Getting started (cont’d)In addition to the pen, please make sure you have these additional supplies, which are not included in the pack:

• Alcohol wipe

• Gauze pad

• Adhesive bandage

• 1 sharps container for throwing away used needles and PLEGRIDY Pens. See “Disposing of your used PLEGRIDY Pens” on page 26

• A well-lit area and a clean, flat surface to work on, like a table

Helpful hint: If your PLEGRIDY® (peginterferon beta-1a) pharmacy did not provide these materials in your shipment, you can call to request them. You can also purchase them at your local pharmacy.


Please see Important Safety Information on back page and provided full Prescribing Information, Medication Guide, and Instructions for Use for additional Important Safety Information.

PLEGRIDY Pen or prefi lled syringe

Alcoholwipe

Gauzepad Bandage

Use this mat to help you prepare for your injection, so you will always have everything you need at your � ngertips. Do not inject until you have been properly trained by a healthcare provider.

Quick Tips• Follow any pre-injection instructions recommended by your doctor including

premedication for � u-like symptoms• Follow the preparation and injection instructions in the Injection Training Guide• Place the PLEGRIDY Pen or pre� lled syringe, alcohol wipe, gauze pad, and adhesive bandage on the mat• Wipe down the mat when � nished and save to reuse for your next injection

Please remember: Read the Instructions for Use that come with your prescription before you start using PLEGRIDY® (peginterferon beta-1a) and each time you get a re� ll.

If you have any questions about your therapy, call an Above MS™ Nurse Educator at 1.800.456.2255.

Preparation Mat

Example—Not for injection use.

Please see enclosed reusable full size mat.

13

To help you prepareRefer to your reusable Preparation Mat to help get organized for your injection. This will help you make sure you have all the supplies you need right there for your injection.


Green Stripes Visible

Injection Status Window

Medication Visible Before Injection

Body Medication Window Cap

Green Checkmark Visible Body

Medication Window Needle Cover


Yellow Plunger Visible After Injection

Needle

14

Note: Before taking your injection:

• Before you prepare your injection, take your PLEGRIDY Pen out of the refrigerator and let it come to room temperature for at least 30 minutes

° Do not use external heat sources such as hot water to warm your PLEGRIDY Pen

• Do not remove the cap until you are ready to inject

• Do not use more than 1 PLEGRIDY Pen every 14 days

Important things to knowGet to know the features of the PLEGRIDY Pen:

Parts of yourPLEGRIDY Pen

before useNote: The needle is covered by the needle cover and the needle will not be seen.

Do not touch or push on the needle cover. You could get a needle stick.

Parts of yourPLEGRIDY Pen

after use

Helpful hint: Talk to your doctor about taking

over-the-counter pain andfever reducers before and/

or after you inject PLEGRIDY® (peginterferon beta-1a).


15

Injecting with the PLEGRIDY Pen

your shottaking


16


Preparing for your injection Step 1: Collect your supplies and wash your hands

• Find a well-lit area and a clean, flat surface like a table and collect all the supplies you will need to give yourself or to receive an injection

• Wash your hands with soap and water

Step 2: Check your PLEGRIDY Pen


• Check the expiration date printed on your PLEGRIDY Pen (See Figure E)

° Do not use PLEGRIDY Pen past the expiration date

• Check the injection status window on your PLEGRIDY Pen. You should see green stripes in the injection status window (See Figure F)

° Do not use PLEGRIDY Pen if you do not see the green stripes in the injection status window

• Check the medication window on your PLEGRIDY Pen and make sure the PLEGRIDY® (peginterferon beta-1a) medicine is clear and colorless (See Figure G)

° Do not use PLEGRIDY Pen if the liquid is colored, cloudy, or has floating particles in it

° You might see air bubbles in the medication window. This is normal and will not affect your dose

Pen: Injection prep


18


Thigh Abdomen Back of Upper Arm

Figure H

19

Choosing your injection site Step 3: Choose your injection site

• PLEGRIDY Pen is for use under the skin only (subcutaneous)

• PLEGRIDY Pen should be injected into your thigh, abdomen, or the back of your upper arm (See Figure H)

° Do not inject into an area of your body where the skin is irritated, reddened, bruised, infected, or scarred

• Change (rotate) your injection site for each injection. Do not use the same injection site for each injection

• Choose an injection site and wipe your skin with an alcohol wipe

• Let your injection site dry on its own before injecting your dose ° Do not touch this area again before giving your injection

• Do not take off the PLEGRIDY Pen cap until you are ready to inject

Helpful hint:

• Don’t inject near your joints (for instance, if you are injecting into your thigh, put a hand on your hip and a hand on your knee, and inject somewhere in between)

Helpful hints: • Wipe injection site in a circular motion (inside

out), and let dry on its own

• Rotate areas of injection with each dose to minimize the likelihood of injection site reactions

Pen: Choosing injection site


20


21

Instructions for injecting with the PLEGRIDY Pen

injectiongiving your

Pen: Giving your injection


22

Figure I

Figure J

Giving your injection

Cap

Needle Cover

90º

Step 4: Remove the PLEGRIDY Pen cap

• Pull the PLEGRIDY Pen cap straight off and set it aside (See Figure I)

° Do not recap your PLEGRIDY Pen

° The needle is covered by the needle cover and the needle will not be seen (See Figure I)

° Do not touch or push down on the needle cover, you could get a needle stick

• Your PLEGRIDY Pen is ready to inject after the cap is removed

Step 5: Place your PLEGRIDY Pen on your injection site

• Place your PLEGRIDY Pen on your chosen injection site

° You should hold your PLEGRIDY Pen at a 90° angle to your injection site so that you can see the green stripes in the injection status window (See Figure J)

° Do not use your PLEGRIDY Pen unless you see green stripes in the injection status window

Helpful hint: Once you take the cap off, avoid touching the tip of the pen again.

Helpful hint: Do not inject into an area of the body where the skin is irritated, reddened, bruised, infected, or scarred in any way.


Figure K

Figure L

Clicking Starts

Click! Click! Click!

Clicking Stops

Step 6: Give your PLEGRIDY Pen injection

• Firmly press and hold down your PLEGRIDY Pen on your injection site.

This will insert the needle and start your injection (See Figure K)

° You will hear a “clicking” sound

• Hold your PLEGRIDY Pen firmly down on your injection site until the “clicking” sound has stopped

° Do not lift your PLEGRIDY Pen off your injection site until the “clicking” sound stops and you see green checkmarks in the injection status window

• After the “clicking” sound has stopped, check the injection status window. You should see green checkmarks in the injection status window (See Figure L)

Helpful hint: Once you have the pen positioned over the injection site you have chosen, bring the pen straight down. This will help make sure you are holding the pen at a 90° angle.

POSITION and PRESS the PLEGRIDY Pen to inject your medicine once every 2 weeks.

Please see additional dosing information on titration, administration instructions, and premedication for flu-like symptoms on page 51.


24

Figure M

Step 7: Remove your PLEGRIDY Pen from your injection site

• Lift your PLEGRIDY Pen from your injection site. The needle cover will be covering all of the needle (See Figure M)

If you have a problem with your injection or are not certain you were successful in delivering your dose,

call us at 1.800.456.2255. We are always here to help.


After your injection

Step 8: Check to make sure you have received your full dose of PLEGRIDY® (peginterferon beta-1a)

• Check the injection status window. You should see green checkmarks in the injection status window (See Figure N)

• Check the medication window. You should see a yellow plunger in the medication window (See Figure O)

° If you see blood at your injection site, wipe it off with gauze and apply an adhesive bandage


Helpful hints:

• Gently massage the injection area

• Cool the injection site after the injection by placing something cold on it, like a gel pack

• Check the injection site after 2 hours for redness, swelling, and tenderness

• Keep the injection site out of direct sunlight for prolonged periods of time

Remember to record your injection in your PLEGRIDY Planner—and set an injection reminder for your next injection date in 14 days.


Medication Status Window

Figure N

Figure O

Pen: After injection


26

After your injection (cont’d)Step 9: Disposing of your used PLEGRIDY Pens

• Put your used PLEGRIDY Pens in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) PLEGRIDY Pens in your household trash

• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

° Made of a heavy-duty plastic

° Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out

° Upright and stable during use

° Leak resistant, and

° Properly labeled to warn of hazardous waste inside the container

• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container

Step 10: Check your injection site

• PLEGRIDY® (peginterferon beta-1a) may commonly cause redness, pain, or swelling of your skin at the injection site

• Call your healthcare provider right away if your injection site becomes swollen and painful or the area looks infected and does not heal within a few days

Please note: Full Instructions for Use are included with this guide.


How should I store PLEGRIDY®?• Store PLEGRIDY® (peginterferon beta-1a) in the refrigerator between 36°F to 46°F (2°C to 8°C)

• If needed, PLEGRIDY may be stored between 36°F to 77°F (2°C to 25°C) for up to 30 days in total

• Keep PLEGRIDY in the original carton to protect it from light

• Do not freeze PLEGRIDY

• Keep PLEGRIDY Pens, needles, and all medicines out of the reach of children


28


29

prefilled syringeabout the PLEGRIDY®


30


About the PLEGRIDY prefilled syringe and Starter PackRefer to these instructions if your doctor has prescribed the PLEGRIDY prefilled syringe Starter Pack. The PLEGRIDY prefilled syringe Starter Pack uses a color-coded system to help you start PLEGRIDY® (peginterferon beta-1a).

Note: After using your orange and blue Starter Pack syringes, you will transition to the gray PLEGRIDY administration dose prefilled syringe (125 mcg), which you will use for each dose following the first 2 doses contained in the Starter Pack. These instructions for injecting also apply to the PLEGRIDY administration dose prefilled syringe.

Read the Instructions for Use before you start using PLEGRIDY and each time you get a refill. There may be new information. Please note that there is only one Instructions for Use document included in each 2-dose pack of PLEGRIDY. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Helpful hint: You might be wondering why you have to first inject using the Starter Pack. Your first injection of PLEGRIDY (orange syringe) contains about half the medicine of a typical dose. Your second injection (blue syringe) contains about three-quarters of a typical dose. Talk to your doctor if you have any questions.

PLEGRIDY prefilled syringe (PFS)


32

About the PLEGRIDY prefi lled syringe and Starter Pack (cont’d)Before you use the PLEGRIDY prefi lled syringe for the fi rst time, your healthcare provider should show you and/or your caregiver how to prepare and inject with the PLEGRIDY prefi lled syringe the right way. An Above MS™ Nurse Educator can also provide additional training on how to use the PLEGRIDY prefi lled syringe and Starter Pack.

The PLEGRIDY prefi lled syringe Starter Pack contains your fi rst 2 injections, which gradually increase your dose ofPLEGRIDY® (peginterferon beta-1a). For each injection after that, use the gray administration dose syringe:

For Day 1: One ORANGE syringe containing 63 mcg of PLEGRIDY

For Day 15: One BLUE syringe containing 94 mcg of PLEGRIDY

For Day 29: One GRAY syringe containing 125 mcg of PLEGRIDY

(and every 14 days after that)


Getting started • Before you use your PLEGRIDY prefilled syringe for the first time, your healthcare provider should show you or your

caregiver how to prepare and inject your PLEGRIDY prefilled syringe the right way


• PLEGRIDY prefilled syringe is for use under the skin only (subcutaneous)

• Each PLEGRIDY prefilled syringe can be used 1 time only. Do not share your PLEGRIDY prefilled syringe with anyone else. By sharing the needle, you may give an infection to them or get an infection from them

• Use PLEGRIDY® (peginterferon beta-1a) exactly as your healthcare provider tells you

Choose a well-lit, clean, flat surface, and collect all the supplies you will need to give yourself an injection or to receive an injection from your caregiver or nurse.

Choose the correct prefilled syringe from the Starter Pack:

Day 1: Choose ORANGE (63 mcg) for your first injection

Day 15: Choose BLUE (94 mcg) for your second injection

Day 29 (and every 14 days after that): Choose GRAY (125 mcg)

As a reminder, after using both prefilled syringes in the Starter Pack, you will use the gray PLEGRIDY administration dose prefilled syringe (125 mcg), which your doctor also prescribed for you. The gray prefilled syringe will be used for your third and subsequent injections.

PFS: Getting started


34

Getting started (cont’d)In addition to the prefilled syringe, please make sure you have these additional supplies which are not included in the pack:

• Alcohol wipe

• Gauze pad

• Adhesive bandage

• 1 sharps container for throwing away used needles and PLEGRIDY prefilled syringes. See “Disposing of your used PLEGRIDY prefilled syringes” on page 47

• A well-lit area and a clean, flat surface to work on, like a table

Helpful hint: If your PLEGRIDY® (peginterferon beta-1a) pharmacy did not provide these materials in your shipment, you can call to request them. You can also purchase them at your local pharmacy.


Please see Important Safety Information on back page and provided full Prescribing Information, Medication Guide, and Instructions for Use for additional Important Safety Information.

PLEGRIDY Pen or prefi lled syringe

Alcoholwipe

Gauzepad Bandage

Use this mat to help you prepare for your injection, so you will always have everything you need at your � ngertips. Do not inject until you have been properly trained by a healthcare provider.

Quick Tips• Follow any pre-injection instructions recommended by your doctor including

premedication for � u-like symptoms• Follow the preparation and injection instructions in the Injection Training Guide• Place the PLEGRIDY Pen or pre� lled syringe, alcohol wipe, gauze pad, and adhesive bandage on the mat• Wipe down the mat when � nished and save to reuse for your next injection

Please remember: Read the Instructions for Use that come with your prescription before you start using PLEGRIDY® (peginterferon beta-1a) and each time you get a re� ll.

If you have any questions about your therapy, call an Above MS™ Nurse Educator at 1.800.456.2255.

Preparation Mat

Example—Not for injection use.

Please see enclosedreusable full size mat.

35

To help you prepareRefer to your reusable Preparation Mat to help get organized for your injection. This will help you make sure you have all the supplies you need right there for your injection.


Medicine Syringe Body PlungerNeedle Cover

36

Important things to knowParts of your PLEGRIDY prefi lled syringe:

Before taking your injection:

• Before you prepare your injection, take your PLEGRIDY prefi lled syringe out of the refrigerator and let it come to room temperature for at least 30 minutes

° Do not use external heat sources such as hot water to warm your PLEGRIDY prefi lled syringe

• Do not use more than 1 PLEGRIDY prefi lled syringe every 14 days

Helpful hint: Follow any pre-injection instructions provided by your doctor.


Injecting with the PLEGRIDY prefilled syringe

your shottaking



38


Figure E

Expiration Date

MedicineFigure D

39

Preparing for your injection Step 1: Collect your supplies and wash your hands

• Find a well-lit area and a clean, fl at surface like a table and collect all the supplies you will need to give yourself or to receive an injection

• Wash your hands with soap and water

Step 2: Check your PLEGRIDY prefi lled syringe

• Check the expiration date printed on your PLEGRIDY prefi lled syringe (See Figure D)

° Do not use PLEGRIDY prefi lled syringe past the expiration date

• Check that your PLEGRIDY® (peginterferon beta-1a) medicine is clear andcolorless (See Figure E)

° Do not use PLEGRIDY prefi lled syringe if the liquid is colored, cloudy,or has fl oating particles in it

° You might see air bubbles in your PLEGRIDY medicine. This is normal and will not affect your dose

PFS: Injection prep


40


Thigh Abdomen Back of Upper Arm

41

PFS: Choosing injection site

Choosing your injection site Step 3: Choose your injection site

• PLEGRIDY prefi lled syringe is for use under the skin only (subcutaneous)

• PLEGRIDY prefi lled syringe should be injected into your thigh, abdomen, or the back of your upper arm (See Figure F) ° Do not inject into an area of your body where the skin is irritated, reddened, bruised, infected, or scarred

• Change (rotate) your injection site for each injection. Do not use the same injection site for each injection

• Choose an injection site and wipe your skin with an alcohol wipe

• Let your injection site dry on its own before injecting your dose ° Do not touch this area again before giving your injection

• Do not take off the PLEGRIDY prefi lled syringe needle coveruntil you are ready to inject

Helpful hint:

• Don’t inject near your joints (for instance, if you are injecting into your thigh, put a hand on your hip and a hand on your knee, and inject somewhere in between)

Helpful hints: • Wipe injection site in a circular motion (inside

out), and let dry on its own

• Rotate areas of injection with each dose to minimize the likelihood of injection site reactions

Figure F


42

43

Instructions for injecting with the PLEGRIDY prefilled syringe

injectiongiving your

PFS: Giving your injection

43



44

Figure G

Needle Cover

Needle

Step 4: Remove the PLEGRIDY prefilled syringe needle cover

• With 1 hand, hold your PLEGRIDY prefilled syringe. With your other hand, firmly hold the needle cover and pull the needle cover straight off the needle (See Figure G)

° Throw away the needle cover after your injection. Do not recap your PLEGRIDY prefilled syringe

° Do not touch the needle

Giving your injection


Figure H

Figure J

90º

Step 5: Give your PLEGRIDY prefilled syringe injection

• With 1 hand, use your thumb and first finger and pinch the skin around your cleaned injection site (See Figure H)

• With your other hand, hold your PLEGRIDY prefilled syringe like a pencil. Use a quick dart-like motion and insert the needle at a 90° angle into your skin (See Figure I)

• After the needle is in, let go of your skin

• Slowly push the plunger down until the syringe is empty (See Figure J)

° Do not take your PLEGRIDY prefilled syringe out of your injection site until you have slowly pushed the plunger all the way down

• Pull the needle straight out of your skin (See Figure K)

° If you see blood at your injection site, wipe it off with gauze and apply an adhesive bandage

• Do not recap your PLEGRIDY prefilled syringe

• Do not reuse your PLEGRIDY prefilled syringe

If you have a problem with your injection or are not certain you were successful in delivering your dose, call us at 1.800.456.2255. We are always here to help.

Figure I

Figure K


46


After your injectionStep 6: Disposing of your used PLEGRIDY prefilled syringes

• Put your used PLEGRIDY prefilled syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) PLEGRIDY prefilled syringes in your household trash

• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

° Made of a heavy-duty plastic

° Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out

° Upright and stable during use

° Leak resistant, and

° Properly labeled to warn of hazardous waste inside the container

• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container

PFS: After injection


48

After your injection (cont’d)Step 7: Check your injection site• PLEGRIDY® (peginterferon beta-1a) may commonly cause redness, pain, or swelling of your skin at the injection site

• Call your healthcare provider right away if your injection site becomes swollen and painful or the area looks infected and does not heal within a few days

Helpful hints:

• Gently massage the injection area

• Cool the injection site after the injection by placing something cold on it, like a gel pack

• Check the injection site after 2 hours for redness, swelling, and tenderness

• Keep the injection site out of direct sunlight for prolonged periods of time

• Don’t forget to record your injection in your PLEGRIDY Planner

• Make sure you have an injection reminder set for your next injection date in 14 days

How should I store PLEGRIDY®?• Store PLEGRIDY in the refrigerator between 36°F to 46°F (2°C to 8°C)

• If needed, PLEGRIDY may be stored between 36°F to 77°F (2°C to 25°C) for up to 30 days in total

• Keep PLEGRIDY in the original carton to protect it from light

• Do not freeze PLEGRIDY

• Keep PLEGRIDY prefilled syringes, needles, and all medicines out of the reach of children


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Important

Safety Information

safety informationimportant

IndicationPLEGRIDY® (peginterferon beta-1a) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS).

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

PLEGRIDY can cause serious side effects. Call your healthcare provider right away if you have any of the symptoms listed below.• Liver problems, or worsening of liver problems including liver

failure and death. Symptoms may include yellowing of your skin or the white part of your eye, nausea, loss of appetite, tiredness, bleeding more easily than normal, confusion, sleepiness, dark colored urine, and pale stools. During your treatment with PLEGRIDY you will need to see your healthcare provider regularly. You will have regular blood tests to check for these possible side effects

• Depression or suicidal thoughts. Symptoms may include new or worsening depression (feeling hopeless or bad about yourself), thoughts of hurting yourself or suicide, irritability (getting upset easily), nervousness, or new or worsening anxiety

Do not take PLEGRIDY if you are allergic to interferon beta or peginterferon beta-1a, or any of the other ingredients in PLEGRIDY.

Before taking PLEGRIDY, 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 liver problems, low blood cell counts, bleeding

problems, heart problems, seizures (epilepsy), thyroid problems, or any kind of autoimmune disease

• Take prescription and over-the-counter medicines, vitamins, and herbal supplements

• Are pregnant or plan to become pregnant. It is not known if PLEGRIDY will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with PLEGRIDY

• Are breastfeeding or plan to breastfeed. It is not known if PLEGRIDY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use PLEGRIDY

PLEGRIDY can cause additional serious side effects including: • Serious allergic reactions. Serious allergic reactions can

happen quickly. Symptoms may include itching, swelling of the face, eyes, lips, tongue, or throat, trouble breathing, feeling faint, anxiousness, skin rash, hives, or skin bumps

• Injection site reactions. PLEGRIDY may commonly cause redness, pain or swelling at the place where the injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected and it does not heal within a few days. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider

• Heart problems, including congestive heart failure. While PLEGRIDY is not known to have any direct effects on the heart, some people who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking interferon beta. If you already have heart failure, PLEGRIDY may cause your heart failure to get worse. Call your healthcare provider right away if you have

Indication and Important Safety Information

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worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using PLEGRIDY®

° Some people using PLEGRIDY may have other heart problems, including low blood pressure, fast or abnormal heart beat, chest pain, heart attack, or a heart muscle problem (cardiomyopathy)

• 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 interferon beta

• Blood problems and changes in your blood tests. PLEGRIDY can decrease your white blood cells or platelets, which can cause an increased risk of infection, bleeding or anemia, and can cause changes in your liver function tests. Your healthcare provider should do blood tests while you use PLEGRIDY to check for side effects

• Seizures. Some people have had seizures while taking PLEGRIDY, including people who have never had seizures before

The most common side effects of PLEGRIDY include: • Flu-like symptoms. Many people who take PLEGRIDY

have flu-like symptoms early in the course of therapy. These symptoms are not really the flu. You cannot pass it on to anyone else. Symptoms may include headache, muscle and joint aches, fever, chills or tiredness

° You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers and drinking plenty of water. For many people, these symptoms lessen or go away over time

Important Dosing Information• See the Instructions for Use for detailed instructions to

prepare for and to inject your dose of PLEGRIDY • A healthcare provider should show you how to inject your

PLEGRIDY before you use it for the first time• When you first use PLEGRIDY, your healthcare provider

may tell you to slowly increase your dose so that you can adjust to the effects of PLEGRIDY before using the full dose. You should use a PLEGRIDY Starter Pack to slowly adjust your dose when you begin treatment

• PLEGRIDY is given by injection under the skin (subcutaneous injection) of your stomach, back of upper arm, or thigh 1 time every 14 days

• Change the site you choose with each injection to help decrease the chance that you will have an injection site reaction

• Talk to your doctor about premedication for management of potential flu-like symptoms

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1.800.FDA.1088.

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

We hope this Injection Training Guide has been helpful. For more information about PLEGRIDY® (peginterferon beta-1a)—and to view a video demonstration on injecting with the PLEGRIDY Pen—visit InjectingPLEGRIDY.com.

© 2016 Biogen. All rights reserved. 02/16 PLG-US-0495

225 Binney Street, Cambridge, MA 02142 1.800.456.2255 PLEGRIDY.com

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