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:
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.
Your healthcare provider should show you how to properly inject before you start injecting on your own.
If you’re prescribed an OBI for your SKYRIZI induction doses (also called starter doses), you’ll receive an Induction Kit with 2 OBI devices.
Make sure you read the Instructions for Use included in your Induction Kit. Also, listen closely during the demonstration for specific instructions on preparing for your starter doses.
ANNOUNCER 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.
Your healthcare provider should show you how to properly inject before you start injecting on your own.
If you’re prescribed an OBI for your SKYRIZI induction doses (also called starter doses), you’ll receive an Induction Kit with 2 OBI devices.
Make sure you read the Instructions for Use included in your Induction Kit. Also, listen closely during the demonstration for specific instructions on preparing for your starter doses.
USES1
SKYRIZI is a prescription medicine used to treat adults with:
- moderately to severely active Crohn's disease.
- moderately to severely active ulcerative colitis.
SAFETY CONSIDERATIONS1
Do not use if you are allergic to SKYRIZI. SKYRIZI may cause serious side effects, including serious allergic reactions, an increased risk of infections, and liver problems.
- Stop using SKYRIZI and get emergency medical help right away if experiencing symptoms of a serious allergic reaction.
- Before starting treatment, your doctor may check for infections and tuberculosis. Tell your doctor right away about any infections or symptoms of infection and about planned or recent vaccines.
- Liver problems may happen while being treated for Crohn’s disease or ulcerative colitis that can lead to hospitalization. Your doctor will do liver blood tests before and during treatment and may stop SKYRIZI if liver problems develop.
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.
SUPER:
If you’re using the OBI device for your starter doses, each Induction Kit will include 2 OBI devices, 2 prefilled cartridges, and an induction specific Instructions for Use.
SUPER:
Imagery of Instructions for Use is for illustrative purposes only.
DAVE (V.O.):
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. This spells out everything you need to do, step-by-step.
SUPER:
Read the Instructions for Use before you start using SKYRIZI and each time you get a refill.
DAVE (V.O.):
This may seem like a long video...
SUPER:
Keep electronic devices including cell phones at least 12 inches (30 cm) from OBI until injection is complete.
DAVE (V.O.):
…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” provides the most detailed directions for preparing and using SKYRIZI. Please read it 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.
Remember, your healthcare provider should show you how to properly inject SKYRIZI before you start injecting on your own.
SUPER:
YOUR HEALTHCARE PROVIDER SHOULD SHOW YOU HOW TO PROPERLY INJECT SKYRIZI
DAVE (V.O.):
If you have any questions, a Skyrizi Complete Ambassador or doctor is there for you and trained to help, in- person or virtually. Just call 1.866.SKYRIZI or chat live 24/7 at SkyriziComplete.com
SUPER:
24/7 SUPPORT
Call 1.866.SKYRIZI (1.866.759.7494)
Live Chat at SkyriziComplete.com
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.
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:
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:
2 ALCOHOL WIPES not included
COTTON BALL not included
SHARPS DISPOSAL CONTAINER not included
INSTRUCTIONS FOR USE
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. The OBI will not work unless it has been left at room temperature for at least 45 minutes.
SUPER:
Check expiration date (EXP) on box.
Do not use SKYRIZI if the expiration date (EXP) has passed.
Leave unopened carton at room temperature to warm.
Keep out of direct sunlight.
Wait at least 45 minutes up to 90 minutes
SUPER:
If you’re starting SKYRIZI with the OBI, make sure you have the right OBI Kit. Your Induction Kit will have 2 OBI devices.
Wait at least 45 minutes up to a maximum of 90 minutes to allow SKYRIZI to warm. The OBI will not work if left at room temperature for less than 45 minutes.
Do not warm SKYRIZI in any other way (for example, do not warm it in a microwave or in hot water).
DAVE (V.O.):
Now that we are ready, take the plastic tray out of the box. Wash and dry your hands. And inside the package, you’ll find your OBI, a medication cartridge, and the Instructions for Use.
SUPER:
- OBI
- MEDICATION CARTRIDGE
Do not let the OBI get wet with water or any other liquids.
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.
SUPER:
Do not use the OBI and prefilled cartridge if the white paper tray seal is missing or damaged and return the carton to the pharmacy.
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.
On the front, you’ll see the status light and the start button. Here’s the gray door and the medicine window.
SUPER:
-MEDICINE WINDOW
-GRAY DOOR
-STATUS LIGHT
-START BUTTON
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:
-ADHESIVE BACKING
-NEEDLE COVER
(WITH THE NEEDLE INSIDE)
-CLEAR PLASTIC STRIP
-GREEN PULL TABS
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.
SUPER:
- DOOR LATCH
DAVE (V.O.):
Always be careful not to touch the back of the OBI, the needle cover, or the needle behind it.
SUPER:
Do not touch the needle cover or the needle.
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.
SUPER:
Do not close the gray door before the prefilled cartridge is loaded.
DAVE (V.O.):
If it happens to be closed, just press firmly on the left side…right here…and swing the door open.
SUPER:
Do not use OBI if you drop it, discover missing pieces, or it is damaged.
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.
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:
Do not touch the gray start button until it is time to inject. It can be pressed 1 time only.
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).
24/7 SUPPORT
Call 1.866.SKYRIZI (1.866.759.7494)
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 OBI. 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.
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:
- LARGER PREFILLED CARTRIDGE TOP
- SMALLER BOTTOM TIP
- WHITE PLUNGER
- MEDICINE
DAVE (V.O.):
If you spin it, on the cartridge label, there’s an expiration date.
Be super careful not to twist or remove the top of the cartridge.
SUPER:
Do not twist or remove the larger prefilled cartridge top.
Do not use if the expiration date (EXP) has passed.
DAVE (V.O.):
Make sure the medicine inside looks clear or yellow—and it does—
SUPER:
Do not use if the liquid is cloudy, discolored, or contains flakes or large particles.
DAVE (V.O.):
—and if it has tiny white or clear particles, or even a few bubbles, don’t worry. That’s normal.
SUPER:
Do not use if the liquid has been frozen (even if thawed).
DAVE (V.O.):
If the cartridge looks cracked or broken, don’t use it, and call your specialty pharmacy.
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.):
Gently clean the smaller bottom tip of the cartridge with your first alcohol wipe, like this…
And once you’ve cleaned it...you’ll want to keep it clean. So, take special care not to touch it.
SUPER:
Do not touch the smaller bottom tip of the prefilled cartridge after cleaning.
DAVE (V.O.):
Now, this is important, you need to start the injection within 5 minutes after loading the prefilled cartridge into the OBI. Waiting more than 5 minutes will dry out the medicine and the OBI will not work afterwards. You might want to set a timer.
SUPER:
Start the injection within 5 minutes after inserting the prefilled cartridge into the OBI
Waiting will dry out the medicine and the OBI will not work afterwards
Set a timer for 5 minutes
DAVE (V.O.):
Now, load the cartridge, small side first, into the OBI. And firmly push down until you hear a “click” (SFX: CLICK). Close the door right away so your medicine doesn’t dry out by squeezing firmly until you hear it “snap” shut. (SFX: SNAP)
Remember, you need to start the injection within 5 minutes after inserting the prefilled cartridge into the OBI. Waiting any longer will dry out the medicine and the OBI will not work afterwards.
SUPER:
Do not twist or remove the prefilled cartridge top.
Insert the medicine cartridge straight into the OBI
Firmly press the prefilled cartridge top until you hear a “click”
Close the gray door firmly until you hear a “snap”
Do not close the gray door if the prefilled cartridge is not fully inserted or is missing.
Start the injection within 5 minutes
Make sure that you start the injection within 5 minutes after inserting the prefilled cartridge into the OBI.
Waiting will dry out the medicine and the OBI will not work afterwards.
DAVE (V.O.):
Let’s talk about how you prepare to inject.
SUPER:
STEP 3
PREPARING TO INJECT
Keep electronic devices including cell phones at least 12 inches (30 cm) from OBI until injection is complete.
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.
SUPER:
Pick your injection site.
- THIGH
- STOMACH
Do not inject into areas of the skin that naturally fold or bulge because the OBI could fall off during wear.
DAVE (V.O.):
And check the instructions if you need help figuring out where to inject.
SUPER:
Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks, moles or excessive hair. Trim excessive hair if needed.
DAVE (V.O.):
Now, clean your injection site with your second alcohol wipe,…and let it dry.
SUPER:
If you are using 2 OBIs for your starter dose, choose a different site that’s at least 2 inches apart from your first site for your second injection.
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:
Turn the OBI over to find both green pull tabs.
DAVE (V.O.):
Being careful not to touch the needle cover or the needle behind it,…
SUPER:
- LARGER
ADHESIVE COVER
- SMALLER
ADHESIVE COVER
Do not touch the needle cover (needle inside) or the needle.
DAVE (V.O.):
…peel the green tab… on the larger cover to expose…the adhesive.
SUPER:
Peel away the large section using the green pull tab to expose the adhesive.
Do not pull the adhesive material off the OBI or allow the sticky side to fold and stick to itself.
Do not touch the needle cover (needle inside) or the needle.
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:
Peel away the small section using the green pull tab to expose the adhesive.
This will remove the clear plastic strip, activating the OBI.
DAVE (V.O.):
You’ll hear some “beeps,” and the status light on the OBI flashes blue.
SUPER:
Do not press the gray start button yet.
- STATUS LIGHT
FLASHING BLUE
The status light will flash blue when the OBI is activated.
If the status light does not flash blue, call 1.866.SKYRIZI (1.866.759.7494).
DAVE (V.O.):
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:
If the status light flashes red and beeps are heard, the OBI is not working properly. Do not continue to use it.
Call 1.866.SKYRIZI (1.866.759.7494) for assistance. If OBI is attached to body, carefully remove from skin.
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:
Remember, you need to start the injection within 5 minutes after inserting the prefilled cartridge into the OBI.
Waiting will dry out the medicine and the OBI will not work afterwards.
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.
SUPER:
2 INCHES
FROM BELLY BUTTON
DAVE (V.O.):
Now if I sit up straight, I find it keeps my skin from folding.
SUPER:
Make sure to adjust your posture (sit up straight) to avoid skin folds and bulges.
DAVE (V.O.):
You don’t need to pull the skin flat if you are injecting in the front of your thigh, though.
SUPER:
You do not need to pull the skin flat for the front of left thigh or right thigh.
DAVE (V.O.):
If you're using the OBI for your SKYRIZI starter doses, you'll be using two devices. You’ll place and inject the first device before you place the second device.
For the second injection, choose a different site at least 2 inches apart from the previous one.
Place the OBI onto your skin so you can see…
SUPER:
If you're using the OBI for your SKYRIZI starter doses, you'll be using two devices. You’ll place and inject the first device before you place the second device.
For the second injection, choose a different site at least 2 inches apart from the previous one.
SUPER:
Do not place the OBI on clothes. Only place on bare skin.
DAVE (V.O.):
… the blue status light.
SUPER:
- STATUS LIGHT
FLASHING BLUE
Do not place the OBI on clothes. Only place on bare 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.
SUPER:
- STATUS LIGHT
FLASHING BLUE
Do not move or adjust the OBI after it has been placed on your skin.
DAVE (V.O.):
Remember, you need to start the injection within 5 minutes after inserting the prefilled cartridge into the OBI.
Waiting more than 5 minutes will dry out the medicine and the OBI will not work afterwards.
SUPER:
Start the injection within 5 minutes
Remember, you need to start the injection within 5 minutes after inserting the prefilled cartridge into the OBI. Waiting will dry out the medicine and the OBI will not work afterwards.
SUPER:
STEP 4
TIME TO INJECT
Do not touch the gray start button until you place the OBI loaded with the prefilled cartridge onto your skin and are ready to inject.
DAVE (V.O.):
Before you press the gray start button, make sure you’ve loaded the prefilled cartridge into the OBI and the OBI is fixed securely to your skin with the adhesive.
SUPER:
Do not touch the gray start button until you place the OBI loaded with the prefilled cartridge onto your skin and are ready to inject.
DAVE (V.O.):
If you're using the OBI for your SKYRIZI starter doses, prepare the second injection and repeat the process with the second OBI device after your first injection has started.
If the gray start button is pressed before the OBI is placed on your body, it can no longer be used.
SUPER:
If you're using the OBI for your SKYRIZI starter doses, prepare the second injection and repeat the process with the second OBI device after your first injection has started.
If the gray start button is pressed before the OBI is placed on your body, it can no longer be used.
Do not touch the gray start button until you place the OBI loaded with the prefilled cartridge onto your skin and are ready to inject.
DAVE (V.O.):
To start, firmly press, then release, the gray start button (SFX: CLICK).
You can only press the start button 1 time.
SUPER:
Firmly press start button one time only until you hear a “click”
If the gray start button is pressed before the OBI is placed on your body, it can no longer be used.
DAVE (V.O.):
You’ll hear a “click” and might feel a needle pinch. That’s normal.
SUPER:
Firmly press start button one time only until you hear a “click”
You can only press the start button 1 time, otherwise OBI activation may be delayed.
DAVE (V.O.):
You’ll hear “beeps” (SFX: BEEPS)…
SUPER:
Listen for beep-beep-beep then check for flashing green status light
Check the status light when the OBI beeps.
DAVE (V.O.):
…and the status light will now flash green. That means you’ve started injecting!
SUPER:
Listen for beep-beep-beep then check for flashing green status light
During the injection, the status light will continue to flash green.
DAVE (V.O.):
You’ll hear pumping sounds (SFX: PUMPING) as the OBI delivers the medicine. The light keeps flashing green until your injection is complete and you’ve gotten the full dose.
SUPER:
You will hear pumping sounds as the OBI delivers the medicine.
DAVE (V.O.):
If the status light flashes red, the OBI isn’t working properly. So just call 1.866.SKYRIZI.
SUPER:
24/7 SUPPORT
Call 1.866.SKYRIZI (1.866.759.7494)
Do not continue to use the OBI if status light flashes red and beeps. Carefully remove from skin if the status light flashes red and beeps. Call 1.866.SKYRIZI (1.866.759.7494).
DAVE (V.O.):
If the OBI is attached to your skin, carefully remove it.
SUPER:
Do not continue to use the OBI if status light flashes red and beeps. Carefully remove from skin if the status light flashes red and beeps. Call 1.866.SKYRIZI (1.866.759.7494).
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:
It may take up to 5 minutes to complete the full dose of SKYRIZI medicine.
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.
SUPER:
During the injection, moderate physical activity can be done, such as walking, reaching, and bending.
The OBI will stop on its own.
DAVE (V.O.):
You will hear “beeps” (SFX: BEEPS)…and the flashing green status light will change to solid green.
SUPER:
-STATUS LIGHT
-SOLID GREEN
After the injection is finished, you will hear beeps and the status light will change to solid green.
DAVE (V.O.):
Now, all that’s left is to take off the OBI.
SUPER:
If the OBI comes off during the injection, it can no longer be used.
DAVE (V.O.):
Grab the corner of the adhesive to peel the OBI off your skin.
SUPER:
Do not reapply it, and call 1.866.SKYRIZI (1.866.759.7494).
DAVE (V.O.):
Nice and easy.
SUPER:
Do not put your fingers on the back side of the OBI when removing it from your skin.
DAVE (V.O.):
Avoid touching the needle cover or needle on the back of the OBI.
SUPER:
Avoid touching the needle cover or needle on the back of the OBI.
DAVE (V.O.):
Now once it’s removed, you’ll hear a few “beeps” (SFX: BEEPS), and the status light will turn off completely.
SUPER:
After removing the OBI, you will hear several beeps and the status light will turn off.
- STATUS LIGHT
OFF
The needle cover will cover the needle when the OBI is removed from the skin.
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:
It is normal to see a few small drops of liquid on your skin after removing the OBI. If you see more than a few small drops of liquid left on your skin, call 1.866.SKYRIZI (1.866.759.7494).
Press a cotton ball or gauze pad over the injection site on your skin and hold for 10 seconds.
Do not rub the injection site.
SUPER:
STEP 5
DISPOSING OF YOUR OBI
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:
- MEDICINE WINDOW FILLED
- STATUS LIGHT OFF
If the used white plunger does not fill the medicine window, call 1.866.SKYRIZI (1.866.759.7494).
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.
SUPER:
Leave the prefilled cartridge in the OBI.
Do not throw away (dispose of) the used OBI in your household trash.
SUPER:
LET’S REVIEW
Reminder: if you're using the OBI for your SKYRIZI starter doses, you'll need 2 OBI devices, 2 prefilled cartridges, and the induction specific Instructions for Use.
DAVE (V.O.):
Let’s do a quick recap.
Remember the 5 Ps as you inject.
SUPER:
1. Prepare
2. Pick
3. Peel
4. Place
5. Press
DAVE (V.O.):
Prepare to inject by gathering alcohol wipes, gauze pads or cotton balls, and your sharps disposal container…
SUPER:
PREPARE EVERYTHING YOU’LL NEED
DAVE (V.O.):
…while your SKYRIZI is warming up to room temperature outside of the fridge.
SUPER:
Wait at least 45 minutes up to 90 minutes
Wait at least 45 minutes up to a maximum of 90 minutes to allow SKYRIZI to warm.
DAVE (V.O.):
That takes from 45 to up to 90 minutes.
SUPER:
The OBI will not work unless it has been left at room temperature for at least 45 minutes.
DAVE (V.O.):
Wash and dry your hands and remember to start the injection within 5 minutes.
SUPER:
Remember, start the injection within 5 minutes
Waiting will dry out the medicine and the OBI will not work afterwards.
DAVE (V.O.):
Pick the place on your body where you’re going to inject.
SUPER:
PICK YOUR INJECTION SITE
DAVE (V.O.):
Peel the 2 green pull tabs to expose the adhesive without touching the needle.
SUPER:
PEEL TO EXPOSE THE ADHESIVE
DAVE (V.O.):
Place the OBI onto your skin. Make sure you can see that status light.
SUPER:
PLACE THE OBI ONTO YOUR SKIN
STATUS LIGHT FLASHING BLUE
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.
SUPER:
FIRMLY PRESS AND RELEASE THE GRAY START BUTTON WHEN READY TO INJECT
DAVE (V.O.):
I hope you’ve seen that injecting at home with the OBI is something you can do.
The Instructions for Use are there to guide you through it.
An Ambassador is dedicated to helping you learn to inject, either in person or virtually, after you receive initial training from your healthcare provider. An Ambassador can support you…
SUPER:
AMBASSADOR SUPPORT
Your healthcare provider should show you how to properly inject before you start injecting on your own.
DAVE (V.O.):
…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:
24/7 SUPPORT
Call 1.866.SKYRIZI (1.866.759.7494)
Live Chat at SkyriziComplete.com
SUPER/ANNOUNCER V.O.:
IMPORTANT SAFETY INFORMATION1
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 may 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)
- 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 or visit https://glowpregnancyregistry.com 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 may happen while being treated for Crohn’s disease or ulcerative colitis: 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 at least 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 and ulcerative colitis include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, urinary tract infection, and rash.
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.
Dosage forms: SKYRIZI (risankizumab-rzaa) 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/PatientAccessSupport to learn more.
Please see link for the full Prescribing Information, including the Medication Guide, for SKYRIZI.
SUPER:
Reference: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
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