How SKYRIZI (risankizumab-rzaa) Works
Voice Over (V.O.):
Doctor: Dan! Hi! Good to see you again.
Dan: You, too.
Doctor: How are you feeling since your last visit?
Dan: Well...my Crohn's symptoms have been getting harder to manage. Is there something else I can try?
Doctor: Good news, Dan. There's a treatment that can help get your Crohn's symptoms under control by targeting an underlying cause of your inflammation.
Dan: I'm listening.
Doctor: It's called SKYRIZI. It's meant to help people like you with moderate to severe Crohn's.
Dan: I've read about SKYRIZI. How does it work?
Doctor: Let me explain it this way. You’re an outdoorsman, right?
Dan: I am.
Doctor: So...imagine you're hiking...and you decide to explore...a cave. A cave that represents an inside look at the intestinal tract of someone with moderate to severe Crohn's.
Doctor: See how the walls are damaged? These rough areas represent inflammation. Inflammation is your body's natural defense against threats, and is normal.
Doctor: Now, the exact cause of Crohn's is not fully known, but when inflammation does get out of control, it may cause damage and contribute to your Crohn's symptoms.
Dan: What causes that excess inflammation in the first place?
Doctor: See this? This represents a protein made by your body called IL-23. IL-23 is one of the proteins that may contribute to excess inflammation when your body produces too much of it.
Doctor: This is where SKYRIZI comes in. SKYRIZI works by specifically targeting and binding to the excess IL-23.
Doctor: This can help reduce inflammation that may contribute to Crohn’s symptoms.
Doctor: Make sense?
Dan: Makes perfect sense. So what now?
Doctor: Because Crohn's is a chronic disease, it's important to find the right treatment for you. And as your doctor, my goal is to help you manage your symptoms and help reduce a source of excess inflammation. Skyrizi can help do that.
Dan: Sounds like SKYRIZI may be an option for me!
Doctor: Now, let's review the important safety information.
USE AND IMPORTANT SAFETY INFORMATION
SKYRIZI® (risankizumab-rzza) USE
SKYRIZI is a prescription medicine used to treat moderate to severe Crohn’s disease in adults.
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
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
- 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.
Please see the full Prescribing Information, including the Medication Guide, for SKYRIZI.
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.
© 2022 AbbVie. All rights reserved. SKYRIZI® and its design are registered trademarks of AbbVie Biotechnology Ltd.