Injecting with the SKYRIZI On-Body Injector

SUPER:

INJECTING WITH THE SKYRIZI ON-BODY INJECTOR

Please see Important Safety Information near the end of this video.

Please see link for the full Prescribing Information, including the Medication Guide, for SKYRIZI.

SUPER/VOICEOVER (V.O.):

This demonstration is a guide to injecting with the SKYRIZI On-Body Injector, or OBI for short. It can be used as a supplemental resource as you make injecting SKYRIZI routine. Be sure to use the Instructions for Use that comes with your OBI as your main resource for injection training.

Read the Instructions for Use before you start using SKYRIZI and each time you get a refill.

USE1

SKYRIZI is a prescription medicine used to treat moderate to severe Crohn's disease in adults.

SAFETY CONSIDERATIONS1

SKYRIZI may cause serious side effects, including:

  • Serious allergic reactions:Stop using SKYRIZI and get emergency medical help right away if you get any symptoms of a serious allergic reaction.
  • Infections: SKYRIZI may increase your risk of infections. Before starting treatment, your doctor should check you for infections and tuberculosis. Tell your doctor right away if you have an infection or symptoms of one.

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.

  • Also, tell your doctor if you plan to or recently received a vaccine.

SKYRIZI may cause serious side effects, including:

  • Liver problems in Crohn’s disease: A person with Crohn’s disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your doctor will do liver blood tests before and during treatment and may stop treatment with SKYRIZI if you develop liver problems.

SUPER:

DAVE

DAVE (V.O.):

Hi, I’m Dave.

Today, I’m gonna show you how to inject SKYRIZI at home with the SKYRIZI On-Body Injector, or OBI for short.

Before you try to inject, you should be shown how to do it correctly by a healthcare professional and read the Instructions for Use that are folded inside your OBI box.

SUPER:

Imagery of Instructions for Use is for illustrative purposes only.

Keep electronic devices, including cell phones, at least 12 inches (30cm) from the OBI until injection is complete.

DAVE (V.O.):

This spells out everything you need to do, step-by-step.

This may seem like a long video, but the injection itself takes about 5 minutes once you press that start button.

SUPER:

1. Prepare

2. Pick

3. Peel

4. Place

5. Press

The “Instructions for Use” provide the most detailed direction for preparing and using SKYRIZI. Please read them before injecting.

DAVE (V.O.):

There are also 5 words that will help you remember. All of them begin with the letter “P.” But I’ll talk more about them later.

SUPER:

For additional help learning to inject, connect with your Nurse Ambassador*.

Just call 1.866.SKYRIZI (1.866.759.7494).

*Nurse Ambassadors are provided by AbbVie and do not work under the direction of your health care professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.

DAVE (V.O.):

If you have any questions, or need additional help with injecting, your Nurse Ambassador is there for you and trained to help. Just call 1.866.SKYRIZI.

SUPER:

CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE

SUPER:

STEP 1:

GET READY

Carton for illustrative purposes only.

DAVE (V.O.):

Let’s talk about getting ready.

Here’s some things that you’re gonna need:

SUPER:

2 ALCOHOL WIPES not included

COTTON BALL not included

SHARPS DISPOSAL CONTAINER not included

INSTRUCTIONS FOR USE

DAVE (V.O.):

2 alcohol wipes, a cotton ball or gauze pad—I got mine from the local pharmacy—a sharps disposal container, and the Instructions for Use.

SUPER:

Check expiration date on box.

DAVE (V.O.):

Then, take your box of SKYRIZI out of the fridge and leave the unopened box out until it warms to room temperature. That takes from 45 to up to 90 minutes.

SUPER:

Do not use SKYRIZI if the expiration date has passed.

Keep out of direct sunlight. Magnetic Resonance (MR) unsafe.

Allow to warm up naturally.

45 to 90 minutes

Leave unopened box at room temperature

Do not warm SKYRIZI in any other way (for example, do not warm it in a microwave or in hot water).

Wait at least 45 minutes up to a maximum of 90 minutes to allow SKYRIZI to warm.

DAVE (V.O.):

Now that we are ready, take the plastic tray out of the box. Wash and dry your hands.

SUPER:

OBI

MEDICATION CARTRIDGE

Do not let the OBI get wet with water or any other liquids.

DAVE (V.O.):

And inside the package, you’ll find your OBI, a medication cartridge, and the Instructions for Use.

SUPER:

Do not use the On-Body Injector and prefilled cartridge if the white paper tray seal is missing or damaged and return the carton to the pharmacy.

DAVE (V.O.):

First, we’re gonna open this OBI tray. Pull back at the arrow to peel away the white paper that keeps the tray sealed.

Next, we need to remove this plastic cover. So, you have to find this rounded opening on the top. Insert your pointing finger into it and your thumb on the opposite side.

Lift off the cover. If you have any questions, just refer to those instructions. They show you exactly what to do.

Now, I’ll take the OBI out of the box.

SUPER:

STATUS LIGHT

START BUTTON

GRAY DOOR

MEDICINE WINDOW

DAVE (V.O.):

On the front, you’ll see the Status Light and the Start Button. Here’s the gray door, and the Medicine Window.

SUPER:

CLEAR PLASTIC STRIP

NEEDLE COVER

(WITH THE NEEDLE INSIDE)

ADHESIVE BACKING

GREEN PULL TABS

DAVE (V.O.):

Turning it around…there’s this clear plastic strip, the needle cover with the needle inside, and the adhesive backing. Here are 2 green pull tabs.

SUPER:

DOOR LATCH

DAVE (V.O.):

On the side, here’s the latch on the open gray door. You’ll notice that I’m holding the OBI by the side. Always be careful not to touch the back of the OBI, the needle cover, or the needle behind it.

SUPER:

Do not close the gray door before the prefilled cartridge is loaded.

Do not use OBI if you drop it, discover missing pieces, or it is damaged.

DAVE (V.O.):

Now, check to make sure the OBI is undamaged, and the gray door at the top is slightly open. Don’t close it.

If it happens to be closed, just press firmly on the left side…right here…and swing the door open.

SUPER:

Do not touch the gray start button until it is time to inject. It can be pressed 1 time only.

DAVE (V.O.):

Now, let’s look at the start button. It can only be pressed once, so be super careful not to press it until you’re ready to inject.

SUPER:

If the gray start button is pressed before placing it on your body, the OBI can no longer be used. Call 1.866.SKYRIZI (1.866.759.7494).

DAVE (V.O.):

If the gray start button is pressed before placing it on your body the OBI can no longer be used and you should call 1.866.SKYRIZI.

SUPER:

CALL 1.866.SKYRIZI

FOR 24/7 SUPPORT WITH

SKYRIZI COMPLETE

Do not touch the needle cover or the needle.

SUPER:

STEP 2:

SET UP ON-BODY INJECTOR

DAVE (V.O.):

Now, let’s go over how to load the OBI with SKYRIZI.

Always holding the OBI this way up, swing the gray door all the way to the right and only close it once the prefilled SKYRIZI cartridge is loaded.

SUPER:

Avoid touching the needle cover or needle on the back of the On-Body Injector. The needle is behind the needle cover.

DAVE (V.O.):

Put your OBI to the side for now. Carefully remove your SKYRIZI cartridge from the plastic tray.

SUPER:

LARGER PREFILLED CARTRIDGE TOP

SMALLER BOTTOM TIP

DAVE (V.O.):

You can see the top of the cartridge is larger than the bottom.

Through this window, there’s a white plunger and the medicine inside the cartridge.

SUPER:

Do not twist or remove prefilled cartridge top.

DAVE (V.O.):

If you spin it, on the cartridge label, there’s an expiration date.

SUPER:

Do not use if the expiration date has passed.

DAVE (V.O.):

Be super careful not to twist or remove the top of the cartridge.

SUPER:

Do not use if the liquid is cloudy, discolored, or contains flakes or large particles.

Do not use if the liquid has been frozen (even if thawed).

DAVE (V.O.):

Make sure the medicine inside looks clear or yellow—and it does—and if it has tiny white or clear particles, or even a few bubbles, don’t worry. That’s normal.

SUPER:

CALL THE PHARMACY

THAT SUPPLIED YOUR OBI FOR RETURN INSTRUCTIONS

Do not use the prefilled cartridge if you drop it, discover missing pieces, or it is damaged.

DAVE (V.O.):

If the cartridge looks cracked or broken, don’t use it and call your specialty pharmacy.

Gently clean the smaller bottom tip of the cartridge with your first alcohol wipe, like this…And once you’ve cleaned it…

SUPER:

Do not touch the smaller bottom tip of the prefilled cartridge after cleaning.

DAVE (V.O.):

…you’ll want to keep it clean. So, take special care not to touch it.

SUPER:

Do not twist or remove the prefilled cartridge top.

DAVE (V.O.):

Now, load the cartridge, small side first, into the OBI. And firmly push down until you hear a “click.” (SFX: CLICK)

SUPER:

Inject within 5 minutes of inserting the cartridge to keep medicine from drying out.

Start the injection within 5 minutes

Do not close the gray door if the prefilled cartridge is not fully inserted or is missing.

DAVE (V.O.):

Close the door right away so your medicine doesn’t dry out by squeezing firmly until you hear it “snap” shut. (SFX: SNAP)

SUPER:

STEP 3:

PREPARING TO INJECT

Keep electronic devices, including cell phones, at least 12 inches (30cm) from the OBI until injection is complete.

DAVE (V.O.):

Let’s talk about how you prepare to inject.

SUPER:

Pick your injection site.

DAVE (V.O.):

I’m going to inject to in my right thigh today, but you can inject in your stomach or the front of either thigh. Just make sure it’s a firm, flat area of the skin with no clothing in the way.

SUPER:

STOMACH

THIGH

Do not inject into areas of the skin that naturally fold or bulge because the On-Body Injector could fall off during wear.

Do not inject into skin that is sore, bruised, red hard, scarred, or has stretch marks, moles or excessive hair. You can trim the excessive hair from the injection area.

DAVE (V.O.):

And check the instructions if you need help figuring out where to inject.

Now, clean your injection site with your second alcohol wipe, and let it dry.

SUPER:

Do not touch the cleaned injection area before placing the OBI on the skin.

DAVE (V.O.):

Next, get ready to place the OBI onto your skin. Remember the 2 green pull tabs on the back of the OBI?

SUPER:

LARGER ADHESIVE COVER

SMALLER ADHESIVE COVER

DAVE (V.O.):

Being careful not to touch the needle cover or the needle behind it, peel the green tab on the larger cover to expose the adhesive.

SUPER:

Avoid pulling adhesive off or letting it fold and stick to itself.

Avoid touching the needle cover (needle inside).

SUPER:

Prepare the OBI for placement.

DAVE (V.O.):

Next, I’m gonna peel the green tab on the smaller cover. This will remove the clear plastic strip, activating the OBI (SFX: BEEP).

SUPER:

Do not press the gray start button yet.

Do not touch the needle cover or the needle.

DAVE (V.O.):

You’ll hear some “beeps”, and the status light on the OBI flashes blue. That tells you that the OBI is ready for use and the OBI’s lights and sounds are starting to guide you through the injection.

SUPER:

STATUS LIGHT

FLASHING BLUE

Do not pull the adhesive material off OBI or allow the sticky side to fold and stick to itself.

If the status light does not flash blue, call 1.866.SKYRIZI (1.866.759.7494)

If the status light flashes red, the OBI is not working properly.

Do not continue using it. Call 1.866.SKYRIZI for assistance.

DAVE (V.O.):

Once you’ve pulled the green pull tabs, you’ve got to place the OBI on your skin.

Be sure to proceed to the next step without delay.

SUPER:

2 INCHES

FROM BELLY BUTTON

DAVE (V.O.):

If you’re injecting into your stomach, hold your skin so the surface is firm and flat, at least 2 inches from your belly button. Now if I sit up straight, I find it keeps my skin from folding. You don’t need to pull the skin flat if you are injecting in the front of your thigh, though.

SUPER:

Watch blue light when placing OBI. Once the OBI is placed, do not move it.

DAVE (V.O.):

Place the OBI onto your skin so you can see the blue status light. And run your finger around the adhesive to make sure the OBI really sticks to your skin. Now you’re ready to inject.

SUPER:

STATUS LIGHT

FLASHING BLUE

Watch blue light when placing OBI. Once the OBI is placed, do not move it.

Do not place the OBI on clothes. Only place on bare skin.

Do not move or adjust the OBI after it has been placed on your skin.

SUPER:

STEP 4:

TIME TO INJECT

DAVE (V.O.):

To start…press the start button firmly. (SFX: CLICK) You’ll hear a “click” and might feel a needle pinch. That’s normal.

SUPER:

Only press the gray start button one time.

Do not continue to use the On-Body Injector if the status light flashes red. Carefully remove it from the skin if the status light flashes red. Call 1.866.SKYRIZI (1.866.759.7494)

SUPER:

CALL 1.866.SKYRIZI

FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE

If the status light flashes red, the OBI is not working properly. Do not continue to use it. Call 1.866.SKYRIZI for assistance. If the OBI is attached to the body, carefully remove it from skin.

DAVE (V.O.):

If the status light flashes red, the OBI isn’t working properly. So just call 1.866.SKYRIZI.

If the OBI is attached to your skin, carefully remove it.

You’ll hear a second “beep” (SFX: BEEP) and the status light will now flash green. That means you’ve started injecting!

SUPER:

STATUS LIGHT

FLASHING GREEN

DAVE (V.O.):

You’ll hear pumping sounds as the OBI delivers the medicine. The light keeps flashing green until your injection is complete and you’ve gotten the full dose.

SUPER:

Completed injection may take up to 5 minutes.

DAVE (V.O.):

That may take up to 5 minutes because the OBI is giving you the right amount of medicine at the right pace.

SUPER:

During the injection, moderate physical activity can be done, such as walking, reaching, or bending.

DAVE (V.O.):

Feel free to move around while this is happening, but don’t do anything too strenuous. When the injection is done, the OBI alerts you again, and it stops automatically. You will hear a third “beep” (SFX: BEEP) and the flashing green status light will change to solid green.

SUPER:

STATUS LIGHT

SOLID GREEN

The injection is not finished until the status light is solid green.

If the OBI comes off during the injection, it can no longer be used.

DAVE (V.O.):

Now, all that’s left is to take off the OBI.

SUPER:

Do not reapply it and call 1.866.SKYRIZI.

DAVE (V.O.):

Grab the corner of the adhesive to peel the OBI off your skin.

SUPER:

Do not put your fingers on the back side of the OBI when removing it from your skin.

DAVE (V.O.):

Nice and easy.

SUPER:

Avoid touching the needle cover or needle on the back of the OBI.

DAVE (V.O.):

Avoid touching the needle cover or needle on the back of the OBI.

Now once it’s removed, you’ll hear a few “beeps” (SFX: BEEPS), and the status light will turn off completely.

SUPER:

STATUS LIGHT

OFF

If you are unsure about the amount of medicine on your skin, give your Nurse Ambassador a call or call 1.866.SKYRIZI.

DAVE (V.O.):

Now, check where you’ve injected. If you see a few small drops of medicine on your skin, that’s okay. Press a cotton ball or gauze pad and hold for 10 seconds. Go easy. Don’t rub. Slight bleeding at the injection site is normal.

SUPER:

Do not rub the injection site.

SUPER:

STEP 5:

DISPOSING OF YOUR OBI

STATUS LIGHT OFF

MEDICINE WINDOW FILLED

If the white plunger does not fill the medicine window, call 1.866.SKYRIZI (1.866.759.7494).

DAVE (V.O.):

Check to see that the green light is off, and the plunger fills the medicine window—from top to bottom—just to make sure you’re done.

SUPER:

Do not throw away (dispose of) the used OBI in your household trash.

DAVE (V.O.):

One last thing. Take the used OBI with the prefilled SKYRIZI cartridge still inside and drop them both into a sharps disposal container, like this one.

SUPER:

For more information about disposing on your own, visit www.SKYRIZI.com or call your Nurse Ambassador.

DAVE (V.O.):

If you don’t have a sharps disposal container, you can get one through your Nurse Ambassador.

SUPER:

LET’S REVIEW

DAVE (V.O.):

Let’s do a quick recap.

SUPER:

1) Prepare

2) Pick

3) Peel

4) Place

5) Press

DAVE (V.O.):

Remember the 5 P’s as you inject.

SUPER:

PREPARE EVERYTHING YOU’LL NEED

DAVE (V.O.):

Prepare to inject by gathering alcohol wipes, gauze pads or cotton balls, and your sharps disposal container while your SKYRIZI is warming up to room temperature outside of the fridge. Wash and dry your hands.

SUPER:

PICK YOUR INJECTION SITE

DAVE (V.O.):

Pick the place on your body where you’re going to inject.

SUPER:

PEEL TO REVEAL THE ADHESIVE

DAVE (V.O.):

Peel the 2 green pull tabs to reveal the adhesive without touching the nfont-UniversLT-65-Boldeedle.

SUPER:

PLACE THE OBI ON YOUR SKIN

DAVE (V.O.):

Place the OBI onto your skin. Make sure you can see that status light.

SUPER:

PRESS AND RESLEASE THE GRAY START BUTTON

DAVE (V.O.):

Press and release the gray start button to begin. You’ll see a flashing green light, and when the injection is complete (SFX: BEEP), the green light goes solid.

I hope you’ve seen that injecting at home with the OBI is something you can do.

SUPER:

If you are looking for in-person training before you start injecting on your own, talk to your healthcare provider or call 1.866.SKYRIZI.(1.866.759.7494).

DAVE (V.O.):

The Instructions for Use are there to guide you through it.

Your Nurse Ambassador is dedicated to helping you learn to inject every step of the way. Connect with them over the phone, in video chat, or in person. With this support, you’ve got this.

SUPER:

If you are looking for in-person training before you start injecting on your own, talk to your healthcare provider or call 1.866.SKYRIZI (1.866.759.7494).

CALL 1.866.SKYRIZI

FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE

SUPER/V.O.:

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)?

SKYRIZI is a prescription medicine that may cause serious side effects, including:

Serious allergic reactions:

  • Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
    • fainting, dizziness, feeling lightheaded (low blood pressure)
    • swelling of your face, eyelids, lips, mouth, tongue, or throat
    • trouble breathing or throat tightness
    • chest tightness
    • skin rash, hives
    • itching

Infections:

SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

  • Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
    • fever, sweats, or chills
    • cough
    • shortness of breath
    • blood in your mucus (phlegm)
    • muscle aches
    • warm, red, or painful skin or sores on your body different from your psoriasis
    • weight loss
    • diarrhea or stomach pain
    • burning when you urinate or urinating more often than normal

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed in the section “What is the most important information I should know about SKYRIZI?”
  • have an infection that does not go away or that keeps coming back.
  • have TB or have been in close contact with someone with TB.
  • have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.
  • are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.
  • become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.

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

What are the possible side effects of SKYRIZI?

SKYRIZI may cause serious side effects. See “What is the most important information I should know about SKYRIZI?”

Liver problems in Crohn’s disease: A person with Crohn’s disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine.

The most common side effects of SKYRIZI in people treated for Crohn’s disease include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection.

These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.

Use SKYRIZI exactly as your healthcare provider tells you to use it.

SKYRIZI is available in a 600 mg/10 mL vial for intravenous infusion and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

SUPER:

Reference: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.

Please see link for the full Prescribing Information, including the Medication Guide, for SKYRIZI.

© 2023 AbbVie. All rights reserved. SKYRIZI® and its design are registered trademarks of AbbVie Biotechnology Ltd.

US-SKZG-230191