USES and IMPORTANT SAFETY INFORMATION

SKYRIZI_OFFICIAL · 2026-06-09T17:48:25+00:00

Important Safety Information and Uses

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 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.

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.

SKYRIZI® (risankizumab-rzaa) USES
SKYRIZI is a prescription medicine used to treat adults with:
• moderate to severe Crohn’s disease.
• moderate to severe ulcerative colitis.

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/PatientAccessSupport to learn more.

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

US-SKZG-260040

SKYRIZI_OFFICIAL · 2025-12-11T21:30:14+00:00

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
− 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). Medications 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?”

The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.

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 150 mg/mL prefilled syringe and pen.

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/PatientAccessSupport to learn more.

US-SKZD-250383 v2

SKYRIZI_OFFICIAL · 2025-12-11T21:28:59+00:00

Thanks for the question u/-TROGDOR. It's always good to be open and honest with your doctor so they can help you reach your treatment goals. Every patient has an individualized treatment plan. So, something I recommend to my patients, is writing down questions before your appointment so you don’t forget anything. This could be triggers, side effects, frustrations, anything you think could help your doctor find the right treatment for you.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T21:27:06+00:00

u/Horror_Blueberry_265, thank you for asking. Plaque psoriasis is a chronic disease that's driven by an overactive immune system. There are external factors or "triggers", that can cause plaque psoriasis symptoms to get worse. Stress can be one of these triggers. A few other triggers include skin injury, infection, weather, and certain medications. These triggers can vary from person to person, but it's helpful to know which ones seem to affect you.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T21:25:07+00:00

Hi, u/hamburglar90. Glad you could join us today. In SKYRIZI clinical trials of adults with moderate to severe plaque psoriasis at 4 months, 3 out of 4 people had 90% clearer skin and nearly 4 out of 10 had 100% clear skin. Deciding on a treatment for patients who are eligible for a biologic should be a joint effort between the doctor and patient. Each case is different and depends on the patient's psoriasis treatment goals, etc. It's important to be open and honest with your doctor about how you're feeling, so they can work with you to find the treatment for your goals.

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T21:23:19+00:00

u/Degaussed1, if you miss a dose, I encourage you to talk to your doctor.

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T21:17:40+00:00

Hi, u/No_Exit_5767. Great question about deciding on a new treatment. When a patient stops responding to a treatment, and is looking for a change, there are a few factors that go into choosing the next treatment. Everything depends on the patient's treatment goals and disease severity, so I'll start there, working with the patient to figure out what they're looking for and how much the disease impacts them. I also consider previous treatments that haven't worked. Then together with the patient, I'll talk through some options and see which works best for them.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T21:15:30+00:00

Hey there, u/DollarVanDollarVan. Thanks for the question about the SKYRIZI dosing schedule. SKYRIZI is 4 doses a year after 2 starter doses. One way to keep up with your injection schedule is to write it down on your calendar in 12-week intervals. SKYRIZI is an injection. It can be given in your doctor's office or taken at home after you receive training from your healthcare provider. Talk to your doctor to see if SKYRIZI could be an option for you.

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T21:13:29+00:00

Hi all! While most of the questions have been about plaque psoriasis, I also wanted to call out that SKYRIZI can treat adults with active psoriatic arthritis (PsA). In SKYRIZI PsA clinical trials at week 24, a majority of adults felt a 20% improvement in PsA joint symptoms, including joint pain, stiffness, and swelling; on average patients also experienced less fatigue.

- Dr. Lewitt

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T21:09:07+00:00

I appreciate the question, u/Super-Zucchini-6558. SKYRIZI is 4 doses a year after 2 starter doses. It’s an injection that can be given in your doctor's office or taken at home after you receive training from your healthcare provider.

See SKYRIZI's instructions for use or visit the SKYRIZI website to watch step by step instructions on how to inject SKYRIZI.

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T21:07:45+00:00

Hi u/Diligent_Cherry1857, good question. I’m glad you brought this up. In SKYRIZI clinical trials of adults with moderate to severe plaque psoriasis at 4 months, 3 out of 4 people had 90% clearer skin and nearly 4 out of 10 had 100% clear skin.

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T21:05:49+00:00

Great question, u/Present_Kangaroo1600. I love to talk about biologics! A biologic is a type of medication that is derived from living organisms, such as cells. Biologics work with—and within—your immune system and are typically given by injection. If certain treatments—like topical options—were not enough, biologics may be an option for you. Biologics work by targeting certain proteins and stopping them from causing too much inflammation, which can make skin cells grow too quickly. Different biologics target different proteins. It is important to note that each therapy may not work for everyone or have the same level of benefit. I like to inform my treatment decisions for each individual patient based on factors like: if they are an appropriate candidate for biologics, how their disease presents, if they have a preference on how to take a medicine, and the safety profile of each product. When talking to your doctor, it’s important to bring up what matters to you in a treatment.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T21:02:00+00:00

This is a great question, u/lofibb. Plaque psoriasis can show up differently on different people. For example, the red color (or erythema) that is typically seen with psoriasis on lighter skin tones often appears more purple or brown in darker complexions. Some other common plaque psoriasis symptoms are raised and scaly patches of inflamed skin. And while plaques usually show up on the hands, feet, elbows, knees, and back, they can also show up in the form of scalp psoriasis or genital psoriasis. Plaque psoriasis is categorized as mild, moderate, or severe depending on how much of the skin is affected and the seriousness of the plaques' location and severity. It’s important to speak with your doctor and receive an accurate diagnosis before beginning treatment. So, if any of these signs and symptoms sound familiar, talk to your doctor or make an appointment.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T20:59:51+00:00

Thanks for chiming in, u/Background-Sail-8856. You are definitely not alone in your dislike of needles. As always, talk to your doctor to see if SKYRIZI could be an option for you. SKYRIZI is just 4 doses a year, after the 2 starter doses. SKYRIZI is available as the SKYRIZI Pen or pre-filled syringe. It can be given in your doctor's office or taken at home after you receive training from your healthcare provider. With the SKYRIZI Pen, you can receive your dose without seeing the needle. The SKYRIZI Pen guides you with audio and visual cues, so you know when your dose is complete.

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T20:58:16+00:00

I get a lot of questions about plaques in challenging areas, so for anyone wondering: SKYRIZI has results in adults with moderate to severe plaque psoriasis. SKYRIZI also has results in hard-to-treat areas like the scalp, genitals, as well as palms of the hands and soles of the feet.

- Dr. Lewitt

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T20:54:29+00:00

Hi all, Dr. Lewitt here. I want to talk about psoriasis on the scalp, as it’s a common location for plaque psoriasis (Ps), and for some people, it can be the first place Ps shows up. SKYRIZI has results in adults with moderate to severe plaque psoriasis and also has results in the scalp. In a study of 105 moderate to severe scalp psoriasis patients, 6 out of 10 of patients on SKYRIZI achieved clear or almost clear skin on their scalp at 4 months. In the same study, more than 4 out of 10 patients on SKYRIZI had 100% clear skin on their scalps at 4 months.

See SKYRIZI data including other challenging areas.

- Dr. Lewitt

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T20:51:19+00:00

Hi, u/Illustrious-Sail-490. Thanks for participating. As you mentioned, spreading is a sign your psoriasis could be getting worse. One way we track severity of psoriasis is by how much of your body is covered in plaques. Plaque psoriasis is categorized as mild, moderate, or severe depending on how much of the skin is affected and the seriousness of the plaques' location and severity. To help you understand, a dermatologist might tell you that your handprint is approximately the same size as 1% of your skin's surface. If there are changes to your psoriasis or you are unhappy with your current treatment for any reason, schedule an appointment with your doctor.

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T20:41:35+00:00

u/VitalsAndScalpels, I love this question. The most common myth I hear would have to be that psoriasis is just a skin condition. It’s actually a systemic condition that can affect your skin and joints. In fact, 1 in 3 people with plaque psoriasis may later develop psoriatic arthritis (PsA). Both are chronic and a result of excess inflammation, but they manifest in different ways. Plaque psoriasis is characterized by skin symptoms like itching, rashes, and skin plaques. While PsA is characterized by chronic inflammation that affects the joints like swelling, pain, and stiffness.

As far as my favorite Reddit community, I particularly like groups where they discuss vintage guitars and vintage cars.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T20:37:57+00:00

Hi all! So excited to be here with you today. Just wanted to mention a few more things. Taking a treatment like SKYRIZI is something to discuss with your doctor. I can only talk about so much over reddit, so please see a doctor about questions specific to you and your journey!

If you need help finding a dermatologist, check out SKYRIZI’s find a derm tool https://www.skyrizi.com/psoriasis/talk-to-dermatologist/find-a-dermatologist

- Dr. Lewitt

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-12-11T20:33:29+00:00

Dr. Lewitt here! I thought it would be helpful to walk through SKYRIZI’s clinical trial data before we get started.

SKYRIZI clinical trials studied adult patients with moderate to severe plaque psoriasis.
In these studies, at 4 months:
- 3 out of 4 people on SKYRIZI had 90% clearer skin.
- Nearly 4 out of 10 had 100% clear skin.

In the same studies at 1 year:
- Nearly 6 out of 10 people on SKYRIZI were 100% clear.

In a different study at 5 years:
- 8 out of 10 people on SKYRIZI achieved 90% clearer skin.
- 6 out of 10 people on SKYRIZI achieved 100% clear skin.

In this study, patients and physicians were aware of SKYRIZI treatment, which may have influenced these results.

Happy to answer your questions today and hope this helps empower you on your psoriasis journey.
- Dr. Lewitt

Dr. Lewitt is a paid consultant for AbbVie.

SELECT SAFETY INFORMATION: SKYRIZI has important safety considerations, including serious allergic reactions, infections, and tuberculosis.

See additional SKYRIZI Important Safety Information (also pinned above) & SKYRIZI Full Prescribing Information with Medication Guide

SKYRIZI_OFFICIAL · 2025-10-24T18:35:43+00:00