Skyrizi

Skyrizi (risankizumab-rzaa) is a prescription biologic medicine used to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Skyrizi can be used for moderate-to-severe plaque psoriasis or active psoriatic arthritis in adults and children 6 years and older, and moderately to severely active Crohn's disease or ulcerative colitis in adults.

Skyrizi works by blocking interleukin-23 (IL-23), a protein that drives inflammation in the skin, joints, and gut. By blocking IL-23, Skyrizi calms an overactive immune response and eases symptoms such as skin plaques, joint pain, and abdominal pain. Skyrizi is an interleukin-23 antagonist.

Skyrizi is given as an injection under the skin (subcutaneous injection) or as an IV infusion, depending on the condition being treated. After initial dosing, Skyrizi is given as an injection under the skin every 12 weeks for plaque psoriasis and psoriatic arthritis, and every 8 weeks for Crohn's disease and ulcerative colitis.

Skyrizi was first FDA-approved in 2019 for plaque psoriasis in adults, and later for psoriatic arthritis, Crohn's disease, and ulcerative colitis. In June 2026, approval was extended to children 6 years and older with plaque psoriasis or psoriatic arthritis.

Skyrizi is FDA-approved for:

• Moderate to severe plaque psoriasis in patients 6 years of age and older who are candidates for systemic therapy or phototherapy
• Active psoriatic arthritis in patients 6 years of age and older
• Moderately to severely active Crohn's disease in adults
• Moderately to severely active ulcerative colitis in adults

Skyrizi's mechanism of action is blocking interleukin-23 (IL-23), a protein in the immune system that triggers inflammation. In psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, the immune system is overactive and produces too much IL-23, which causes the symptoms of these conditions.

Skyrizi (risankizumab-rzaa) is a humanized monoclonal antibody, meaning it is an engineered protein designed to seek out and bind to a specific target. It attaches to the p19 subunit of IL-23, blocking IL-23 from connecting to its receptor on immune cells. This interrupts the inflammatory chain reaction that drives tissue damage in these conditions.

Skyrizi is given as an injection under the skin (subcutaneous) using a prefilled pen, prefilled syringe, or on-body injector, or as an IV infusion in a clinic, depending on the condition being treated.

• Use exactly as your healthcare provider tells you to use it.
• Your healthcare provider will tell you how much is right for you and how often you should receive it.
• Subcutaneous injections can be given at home after proper training from a healthcare provider.
• Adults can self-administer.
• In children 10 years of age and older, it is recommended that the 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.
• IV infusions for Crohn's disease and ulcerative colitis are given in a clinic or infusion center.
• On-body injector (OBI): some maintenance doses for Crohn's disease and ulcerative colitis use a wearable on-body injector placed on your skin. A healthcare provider or nurse will show you how to use it.

Do not change your dose or stop treatment without talking to your provider first.

Dispose of used needles and syringes in an approved sharps container, never in a regular trash can.

Risankizumab-rzaa affects your immune system. Before you start, your healthcare provider will check if you have an infection or tuberculosis, and make sure your vaccinations are up to date. This medicine can also cause serious allergic reactions and liver problems.

Serious infections

Skyrizi can increase your risk of serious infections. Do not start Skyrizi if you have an active, clinically important infection, and tell your provider if you have a chronic infection or infections that keep coming back. Your provider may pause treatment if you develop an infection. See serious side effects below for the signs to watch for.

Tuberculosis (TB)

Your provider will check you for TB before you start Skyrizi. If you have a history of TB or have active TB, your provider may treat you for TB before you begin Skyrizi. Your provider will also watch for signs of TB during and after treatment. Tell your provider if you have ever had TB or have been in close contact with someone who has it.

Liver problems

Skyrizi has been associated with drug-induced liver injury (hepatotoxicity). If you are being treated for moderately to severely active Crohn's disease or ulcerative colitis, your provider will check your liver enzymes and bilirubin before you start and during at least the first 12 weeks of treatment, and as needed after that.

Serious allergic reactions

Skyrizi can cause serious allergic reactions, including anaphylaxis. See serious side effects below for the symptoms that need emergency help.

Vaccines

Do not receive live vaccines during treatment. See drug interactions below for which vaccines this affects.

You should not use Skyrizi if you are allergic to it or any of the ingredients in this medicine. Before you start using Skyrizi, tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you have or ever had:

• an active, chronic, or recent infection;
• tuberculosis, been exposed to tuberculosis, or if you recently traveled;
• recently received or are scheduled to receive any vaccine; or
• liver disease.

Pregnancy

Tell your doctor if you are pregnant or planning to become pregnant. It is not known if this medicine can harm your unborn baby. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this medicine on the baby. The purpose of the pregnancy registry is to collect information about your health and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.

Breastfeeding

Before you start this medicine, tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if this medicine passes into your breast milk.

Common side effects

The most common Skyrizi side effects are upper respiratory infections (colds, sinus infections), headache, joint pain, fungal infections (athlete's foot, ringworm), and injection site reactions (redness, pain, bruising, swelling).

Side effects can vary depending on the condition being treated and whether you are in the starting (induction) or ongoing (maintenance) phase of treatment.

Serious side effects

Risankizumab-rzaa may cause serious side effects, including allergic reactions, infections, and liver problems.

Serious allergic reactions. Stop using this medicine and get emergency medical help right away if you get any symptoms of a serious allergic reaction:

• fainting, dizziness, feeling lightheaded (low blood pressure)
• swelling of face, eyelids, lips, mouth, tongue, or throat
• trouble breathing or throat tightness
• chest tightness
• skin rash, hives
• itching

Infections. This medicine may lower the ability of your immune system to fight infections. You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection, such as:

• fever, sweats, or chills
• muscle aches
• weight loss
• cough or shortness of breath
• blood in your mucus (phlegm)
• warm, red, or painful skin or sores on your body different from your psoriasis
• diarrhea or stomach pain
• burning when you urinate or urinating more often than normal

Liver problems (hepatotoxicity). Your healthcare provider may stop treatment if you develop liver problems. Tell your healthcare provider right away if you have symptoms including unexplained rash, nausea, vomiting, loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Your treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In clinical trials, Skyrizi worked better than placebo for all four approved conditions: plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Skyrizi for plaque psoriasis

In trial PsO-1 (ultIMMa-1), 75% of adults with plaque psoriasis using Skyrizi had nearly clear skin (PASI 90, a 90% or greater improvement) at 16 weeks, compared with 5% on placebo.

Skyrizi for psoriatic arthritis

In trial PsA-1 (KEEPsAKE-1), 56.3% of adults with psoriatic arthritis using Skyrizi had at least a 20% improvement in tender and swollen joints and other signs of disease activity (ACR20 response) at 16 weeks, compared with 33.4% on placebo. At 24 weeks, 57.3% of adults using Skyrizi had an ACR20 response, compared with 33.5% on placebo.

Skyrizi for Crohn's disease

In trial CD-1 (ADVANCE), 45% of adults with Crohn's disease using Skyrizi were in clinical remission at 12 weeks, compared with 25% on placebo. Clinical remission means low disease activity, measured as a Crohn's Disease Activity Index (CDAI) score below 150.

Skyrizi for ulcerative colitis

In trial UC-1 (INSPIRE), 36% of adults with ulcerative colitis using Skyrizi had visible healing of the colon lining (endoscopic improvement) at 12 weeks, compared with 12% on placebo. Endoscopic improvement means a score of 1 or less on a camera exam of the colon, with no fragile tissue (friability).

For plaque psoriasis and psoriatic arthritis, Skyrizi is injected under the skin at Week 0 and Week 4, then every 12 weeks. For Crohn's disease, treatment starts with either 3 IV infusions at Weeks 0, 4, and 8, or injections under the skin at Weeks 0, 2, 4, and 8. For ulcerative colitis, treatment starts with 3 IV infusions at Weeks 0, 4, and 8. For both Crohn's disease and ulcerative colitis, treatment continues with an injection under the skin at Week 12 and every 8 weeks after that.

IV infusions are given by a healthcare provider over at least 1 hour (600 mg) or at least 2 hours (1,200 mg). For Crohn's disease and ulcerative colitis, your doctor will use the lowest maintenance dose that keeps your condition under control. Children aged 6 to under 10 should have their injections given by an adult; children 10 and older can inject with an adult supervising.

If you miss an injection you give yourself at home. Inject the dose as soon as you remember, then go back to your regular schedule. Do not inject two doses at once to make up for a missed one. Call your healthcare provider if you are not sure what to do.

If you miss an infusion appointment. IV starter doses for Crohn's disease and ulcerative colitis are given in a clinic at Weeks 0, 4, and 8. If you miss one of these appointments, call the clinic to reschedule rather than waiting for your next planned visit.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

The Skyrizi prescribing information does not list any known drug interactions. In studies in people with plaque psoriasis, Crohn's disease, or ulcerative colitis, Skyrizi did not meaningfully change how the body breaks down several common medicines, including caffeine, warfarin, omeprazole, metoprolol, and midazolam. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Vaccines

Do not receive live vaccines while using Skyrizi. Examples of live vaccines include MMR (measles, mumps, rubella), chickenpox (varicella), and the nasal spray flu vaccine. There are other live vaccines, including some travel vaccines, so ask your healthcare provider whether a vaccine is live before you receive it.

Before you start Skyrizi, your healthcare provider should check that you have had all vaccinations recommended for your age. If you need a live vaccine, it should be given before treatment starts.

It is not known how well live or non-live vaccines work in people using Skyrizi.

Not all possible drug interactions are listed here.

• Store in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze. Discard if it has been frozen.
• Do not shake Skyrizi.
• Keep Skyrizi in its original carton to protect it from light until you are ready to use it.
• Before injecting, remove the pen or syringe from the refrigerator and allow it to warm to room temperature for 15 to 90 minutes (depending on the formulation), without removing it from the carton.
• Diluted IV solutions can be stored refrigerated for up to 20 hours, or at room temperature below 77°F (25°C) for up to 8 hours after preparation.
• Do not use Skyrizi after the expiration date on the carton.
• Keep out of reach of children.
• Skyrizi is not made with natural rubber latex.

Dispose of unused medication through a medication take-back program. Ask your pharmacist or healthcare provider for the nearest location. If no take-back program is available, ask your pharmacist how to dispose of Skyrizi safely.

The cost for prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our Skyrizi price guide page for more information about the cost of Skyrizi.

You may also be eligible for a Skyrizi savings card or coupon. Ask your doctor or pharmacist if you qualify.

Active ingredient: risankizumab-rzaa

Inactive ingredients for 55 mg/0.37 mL prefilled syringe, 150 mg/mL prefilled pen or prefilled syringe, 180 mg/ 1.2 mL prefilled syringe or prefilled cartridge, 360 mg/2.4 mL prefilled cartridge, and 600 mg/ 10 mL vial inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate, trehalose, and Water for Injection, USP

Manufacturer: AbbVie Inc., North Chicago, IL 60064