Injecting with the SKYRIZI On-Body Injector
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INJECTING WITH THE SKYRIZI ON-BODY INJECTOR
This demonstration is a guide to injecting with the SKYRIZI On-Body Injector (OBI). 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.
Please see Instructions for Use and Important Safety Information within the website.
Please see full Prescribing Information, including Medication Guide, and discuss with your doctor.
Voice Over (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.
On-screen text:
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 health care professional.
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Imagery of Instructions for Use is for illustrative purposes only.
Dave (V.O.):
And read the Instructions for Use that are folded inside your OBI box. 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.
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Keep electronic devices, including cell phones, at least 12 inches (30 cm) from the OBI until injection is complete.
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.
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- Prepare
- Pick
- Peel
- Place
- Press
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The "Instructions for Use" provide the most detailed direction for preparing and using SKYRIZI. Please read them before injecting.
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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.
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CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE
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STEP 1: GET READY
Carton for illustrative purposes only.
Dave (V.O.):
Let’s talk about getting ready.
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2 ALCOHOL WIPES not included
COTTON BALL not included
SHARPS DISPOSAL CONTAINER not included
INSTRUCTIONS FOR USE
Dave (V.O.):
Here’s some things that you’re gonna need: 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.
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Check expiration date on box.
Do not use SKYRIZI if the expiration date has passed.
Keep out of direct sunlight. Magnetic Resonance (MR) unsafe.
Allow to warm up naturally.
Dave (V.O.):
Then, take your box of SKYRIZI out of the fridge.
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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).
Dave (V.O.):
And leave the unopened box out until it warms to room temperature. That takes from 45 to up to 90 minutes.
On-screen text:
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.
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MEDICATION CARTRIDGE
OBI
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.
First, we’re gonna open this OBI tray.
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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.):
Pull back at the arrow to peel away the white paper that keeps the tray sealed.
Dave (V.O.):
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.
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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.
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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.
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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.
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Do not close the gray door before the prefilled cartridge is loaded.
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.
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Do not use OBI if you drop it, discover missing pieces, or it is damaged.
Dave (V.O.):
If it happens to be closed, just press firmly…left side…right here…and swing the door open.
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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.
On-screen text:
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,...
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CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE
Do not touch the needle cover or the needle.
Dave (V.O.):
..the OBI can no longer be used and you should call 1.866.SKYRIZI.
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STEP 2: SET UP ON-BODY INJECTOR
Dave (V.O.):
Now, let’s go over how to load the OBI with SKYRIZI.
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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.):
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. Put your OBI to the side for now.
Carefully remove your SKYRIZI cartridge from the plastic tray.
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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. If you spin it, on the cartridge label, there’s an expiration date.
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EXPIRATION DATE
Do not twist or remove prefilled cartridge top.
Do not use if the expiration date has passed.
Do not use if the liquid is cloudy, discolored, or contains flakes or large particles.
Dave (V.O.):
Be super careful not to twist or remove the top of the cartridge. 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. If the cartridge looks cracked or broken, don’t use it and call your specialty pharmacy.
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Do not use if the liquid has been frozen (even if thawed).
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.):
Gently clean the smaller bottom tip of the cartridge with your first alcohol wipe, like this. And once you’ve cleaned it, you’ll wanna keep it clean. So, take special care not to touch it.
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Do not touch the smaller bottom tip of the prefilled cartridge after cleaning.
Do not twist or remove the prefilled cartridge top.
Inject within 5 minutes of inserting the cartridge to keep medicine from drying out.
Dave (V.O.):
Now, load the cartridge, small side first, into the OBI. And firmly push down until you hear a “click.”
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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.
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STEP 3: PREPARING TO INJECT
Keep electronic devices, including cell phones, at least 12 inches (30 cm) from the OBI until injection is complete.
Dave (V.O.):
Let’s talk about how you prepare to inject.
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Pick your injection site.
Do not inject into areas of the skin that naturally fold or bulge because the On-Body Injector could fall off during wear.
STOMACH
THIGH
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.):
I’m going to inject 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. And check the instructions if you need help figuring out where to inject.
Dave (V.O.):
Now, clean your injection site with your second alcohol wipe and let it dry.
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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?
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LARGER
ADHESIVE COVER
SMALLER
ADHESIVE COVER
Dave (V.O.):
Being careful not to touch the needle cover or the needle behind it…
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Avoid pulling adhesive off or letting it fold and stick to itself.
Avoid touching the needle cover (needle inside).
Prepare the OBI for placement.
Dave (V.O.):
…peel the green tab on the larger cover to expose the adhesive.
Next, I’m gonna peel the green tab on the smaller cover. This will remove the clear plastic strip activating the OBI.
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Do not press the gray start button yet.
Dave (V.O.):
You’ll hear some “beeps,” and the status light on the OBI flashes blue.
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Do not touch the needle cover or the needle.
STATUS LIGHT
FLASHING BLUE
Do not pull the adhesive material off OBI or allow the sticky side to fold and stick to itself.
Dave (V.O.):
That tells you the OBI is ready for use and the OBI’s lights and sounds are starting to guide you through the injection.
On-screen text:
If the status light does not flash blue, call 1.866.SKYRIZI (1.866.759.7494).
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.
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If the status light flashes red, the OBI is not working properly.
Do not continue using it. Call 1.866.SKYRIZI for assistance.
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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’re injecting in the front of your thigh, though.
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Watch blue light when placing OBI. Once the OBI is placed, do not move it.
STATUS LIGHT
FLASHING BLUE
Do not place the OBI on clothes. Only place on bare skin.
Dave (V.O.):
Place the OBI onto your skin so you can see the blue status light.
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Do not move or adjust the OBI after it has been placed on your skin.
Dave (V.O.):
And run your finger around the adhesive to make sure the OBI really sticks to your skin. Now you’re ready to inject.
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STEP 4: TIME TO INJECT
Only press the gray start button one time.
Dave (V.O.):
To start, press the start button firmly.
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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).
CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE
Dave (V.O.):
You’ll hear a “click” and might feel a needle pinch. That’s normal.
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”, and the status light will now flash green. That means you’ve started injecting!
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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 body, carefully remove it from skin.
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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.
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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.
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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.
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The injection is not finished until the status light is solid green.
Dave (V.O.):
When the injection is done, the OBI alerts you again, and it stops automatically. You’ll hear a third “beep”, and the flashing green status light will change to solid green.
On-screen text:
STATUS LIGHT
SOLID GREEN
If the OBI comes off during the injection, it can no longer be used.
Do not reapply it and call 1.866.SKYRIZI.
Dave (V.O.):
Now, all that’s left is to take off the OBI.
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Do not put your fingers on the back side of the OBI when removing it from your skin.
Avoid touching the needle cover or needle on the back of the OBI.
Dave (V.O.):
Grab the corner of the adhesive to peel the OBI off your skin. Nice and easy.
Avoid touching the needle cover or needle on the back of the OBI.
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STATUS LIGHT
OFF
Dave (V.O.):
Now once it’s removed, you’ll hear a few “beeps”, and the status light will turn off completely.
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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.
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Do not rub the injection site.
Dave (V.O.):
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.
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STEP 5: DISPOSING OF YOUR OBI
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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.
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Do not throw away (dispose of) the used OBI in your household trash.
For more information about disposing on your own, visit www.SKYRIZI.com or call your Nurse Ambassador.
Dave (V.O.):
But 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.
If you don’t have a sharps disposal container, you can get one through your Nurse Ambassador.
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LET’S REVIEW
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- Prepare
- Pick
- Peel
- Place
- Press
Dave (V.O.):
Let’s do a quick recap. Remember the 5 P’s as you inject.
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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.
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PICK YOUR INJECTION SITE
Dave (V.O.):
Pick the place on your body where you’re going to inject.
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PEEL TO REVEAL THE ADHESIVE
Dave (V.O.):
Peel the 2 green pull tabs to reveal the adhesive without touching the needle.
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PLACE THE OBI ON YOUR SKIN
Dave (V.O.):
Place the OBI onto your skin. Make sure you can see that status light.
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PRESS AND RELEASE 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, the green light goes solid.
I hope you’ve seen that injecting at home with the OBI is something you can do.
On-screen text:
If you are looking for in-person training before you start injecting on your own, talk to your health care 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.
On-screen text:
CALL 1.866.SKYRIZI FOR 24/7 SUPPORT WITH SKYRIZI COMPLETE
Dave (V.O.):
Connect with them over the phone, in video chat, or in person. With this support, you’ve got this.
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USE
SKYRIZI is a prescription medicine used to treat moderate to severe Crohn’s disease in adults.
SAFETY CONSIDERATIONS
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.
Please see Use and Important Safety Information within the website.
Please see accompanying full Prescribing Information, including Medication Guide, and discuss with your doctor.
V.O.:
SAFETY CONSIDERATIONS
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.
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SAFETY CONSIDERATIONS1
SKYRIZI may cause serious side effects, including:
- Liver problems in Crohn’s disease: A person with Crohn’s disease who received SKYRIZI by intravenous infusion 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.
Reference: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
Please see Use and Important Safety Information within the website.
Please see accompanying full Prescribing Information, including Medication Guide, and discuss with your doctor.
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.
US-SKZG-220534
Please see Use and Important Safety Information within the website.
Please see accompanying full Prescribing Information, including Medication Guide, and discuss with your doctor.
V.O.:
SKYRIZI may cause serious side effects, including:
Liver problems in Crohn’s disease: A person with Crohn’s disease who received SKYRIZI by intravenous infusion 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.
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.