Risankizumab

What it is used for

SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. active psoriatic arthritis in adults and pediatric patients 6 years of age and older. moderately to severely active Crohn's disease in adults.

moderately to severely active ulcerative colitis in adults. 1.1 Plaque Psoriasis SKYRIZI ® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults and pediatric patients 6 years of age and older.

1.3 Crohn’s Disease SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults. 1.4 Ulcerative Colitis SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

The most important thing to know

SKYRIZI 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) ● chest tightness ● swelling of your face, eyelids, lips, mouth, tongue, or throat ● skin rash, hives ● trouble breathing or throat tightness ● 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 ● muscle aches ● weight loss ● cough ● warm, red, or painful skin or sores on your body different from your psoriasis ● diarrhea or stomach pain ● shortness of breath ● burning when you urinate or urinating more often than normal ● blood in your mucus (phlegm) See “

Side effects, and when to stop

” for more information about side effects. What is SKYRIZI? SKYRIZI is a prescription medicine used to treat: moderate to severe plaque psoriasis in adults and children 6 years of age and older who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). active psoriatic arthritis in adults and children 6 years of age and older.

moderate to severe Crohn’s disease in adults. moderate to severe ulcerative colitis in adults. It is not known if SKYRIZI is safe and effective in children under 6 years of age with moderate to severe plaque psoriasis or active psoriatic arthritis. It is not known if SKYRIZI is safe and effective in children with Crohn’s disease or ulcerative colitis.

Who should not use SKYRIZI? Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the end of this Medication Guide for a complete list of ingredients in SKYRIZI. 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. If you become pregnant while taking SKYRIZI, you are encouraged to enroll in the Pregnancy Registry.

The purpose of the pregnancy registry is 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.

How should I use SKYRIZI? See the detailed “Instructions for Use” that comes with SKYRIZI for information on how to prepare and inject a dose of SKYRIZI, and how to properly throw away (dispose of) a used SKYRIZI prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector. Use SKYRIZI exactly as your healthcare provider tells you to use it.

Your healthcare provider will tell you how much SKYRIZI is right for you and how often you should receive it. Before self-injecting with SKYRIZI prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector, your healthcare provider should show you how to inject SKYRIZI. For children 6 years of age and older: In children 10 years of age and older, it is recommended that SKYRIZI prefilled pen or prefilled syringe be given by an adult or with an adult watching (supervision).

In children 6 years to less than 10 years of age, SKYRIZI should be given by an adult. If you miss your SKYRIZI dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do. If you inject more SKYRIZI than prescribed, call your healthcare provider right away.

Adults and children 6 years of age and older with moderate to severe plaque psoriasis or active psoriatic arthritis will receive SKYRIZI as an injection under the skin (subcutaneous injection) using the prefilled pen or prefilled syringe. Adults with moderately to severely active Crohn’s disease or moderately to severely active ulcerative colitis will receive their starter doses with SKYRIZI through a vein in the arm (intrave

Storing it

Store SKYRIZI in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze SKYRIZI. Do not shake SKYRIZI. Keep SKYRIZI in the original carton to protect it from light. SKYRIZI is not made with natural rubber latex. Keep SKYRIZI and all medicines out of the reach of children.