Full Prescribing Information Medication Guide

IMPORTANT SAFETY INFORMATION AND USE

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.

SKYRIZI® (risankizumab-rzaa) USE

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

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.

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SKYRIZI® and its design are registered trademarks of AbbVie Biotechnology Ltd.

US-SKZG-220265