Skyrizi (Risankizumab)
IL-23 inhibitor for Crohn's disease and ulcerative colitis
Quick Facts About Skyrizi
Key Takeaways About Skyrizi
- Targeted biologic therapy: Skyrizi selectively blocks IL-23, a key driver of intestinal inflammation in Crohn's disease and ulcerative colitis
- Two-phase treatment: Treatment starts with intravenous infusions (induction), then transitions to self-administered subcutaneous injections every 8 weeks (maintenance)
- Avoid live vaccines: Do not receive live or live-attenuated vaccines during Skyrizi treatment; complete vaccinations before starting therapy
- Infection risk: Skyrizi may lower your ability to fight infections; report any signs of infection (fever, cough, flu-like symptoms) to your doctor promptly
- Not for children: Skyrizi is not recommended for patients under 18 years of age due to insufficient data in this population
What Is Skyrizi and What Is It Used For?
Skyrizi (risankizumab) is a prescription biologic medicine that blocks interleukin-23 (IL-23), a protein that causes inflammation. It is approved for treating adults with moderate to severe Crohn's disease and moderate to severe ulcerative colitis when previous treatments have been inadequate.
Skyrizi belongs to a class of medications known as interleukin-23 (IL-23) inhibitors. It contains the active substance risankizumab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody produced by recombinant DNA technology. IL-23 is a naturally occurring cytokine that plays a central role in regulating immune and inflammatory responses, particularly in the gastrointestinal tract.
In inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, the immune system mistakenly attacks the lining of the gastrointestinal tract, causing chronic inflammation, pain, diarrhea, and other debilitating symptoms. IL-23 is overproduced in these conditions, driving a cascade of inflammatory signals through activation of T-helper 17 (Th17) cells and other immune pathways. By selectively binding to the p19 subunit of IL-23 and blocking its interaction with the IL-23 receptor, risankizumab interrupts this inflammatory cycle and helps reduce intestinal inflammation.
Crohn's Disease
Crohn's disease is a chronic inflammatory condition that can affect any part of the gastrointestinal tract, from the mouth to the anus, though it most commonly involves the small intestine and the beginning of the large intestine. Skyrizi is indicated for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant of conventional therapy or a biologic agent. Clinical trials (ADVANCE, MOTIVATE, and FORTIFY) demonstrated that risankizumab achieved clinical remission in a significantly higher proportion of patients compared to placebo, with sustained remission maintained through one year of treatment.
Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory disease limited to the colon (large intestine) and rectum, characterized by continuous mucosal inflammation that typically begins in the rectum and extends proximally. Skyrizi is indicated for adults with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant of either conventional therapy or a biologic agent. The INSPIRE and COMMAND clinical trials showed that risankizumab induced and maintained clinical remission, with significant improvements in endoscopic outcomes and patient-reported quality of life.
Skyrizi is also approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults. However, the dosing regimen and formulation may differ for these indications. This article focuses primarily on the use of Skyrizi for inflammatory bowel disease (Crohn's disease and ulcerative colitis).
What Should You Know Before Taking Skyrizi?
Before starting Skyrizi, tell your doctor about any active infections, history of tuberculosis, recent or planned vaccinations, pregnancy or breastfeeding, and all other medications you are taking. Do not use Skyrizi if you have a serious active infection or are allergic to risankizumab.
Before your doctor prescribes Skyrizi, they will conduct a thorough medical assessment to ensure this treatment is appropriate for you. It is essential to provide your healthcare team with a complete medical history, including information about current and past infections, vaccination status, and any other medications or supplements you are taking.
Contraindications
You must not use Skyrizi in the following situations:
- Hypersensitivity: If you are allergic to risankizumab or any of the other ingredients in Skyrizi (sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, water for injections)
- Active serious infection: If you have a clinically significant active infection, such as active tuberculosis (TB). Your doctor must assess and treat the infection before Skyrizi can be started
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before and during treatment with Skyrizi if any of the following apply to you:
- Current or recurrent infections: Skyrizi may lower your body's ability to fight infections. Tell your doctor immediately if you develop signs of an infection such as fever, flu-like symptoms, night sweats, fatigue, shortness of breath, a persistent cough, warm/red/painful skin, or a painful rash with blisters
- Tuberculosis (TB): Your doctor will test you for TB before starting Skyrizi. If you have latent TB, you may need treatment for TB before beginning Skyrizi therapy
- Vaccinations: You should not receive live or live-attenuated vaccines while being treated with Skyrizi. It is recommended to complete all age-appropriate immunizations before starting therapy. Inactivated vaccines can generally be given during treatment
Skyrizi can cause serious allergic reactions, including anaphylaxis, which may be life-threatening. Seek immediate medical attention if you experience any of the following symptoms:
- Difficulty breathing or swallowing
- Swelling of the face, lips, tongue, or throat
- Low blood pressure, which may cause dizziness or feeling faint
- Severe itching with a red rash or raised bumps
Serious allergic reactions (anaphylaxis) are rare, occurring in up to 1 in 1,000 patients.
Pregnancy and Breastfeeding
There is limited clinical data on the use of risankizumab during pregnancy. Animal reproductive studies have not shown direct harmful effects on fertility, embryo-fetal development, or postnatal development; however, as a precautionary measure, the use of Skyrizi during pregnancy should be avoided unless the potential benefit to the mother outweighs the potential risk to the fetus.
Women of childbearing potential should use effective contraception during treatment and for at least 21 weeks after the last dose of Skyrizi. This interval is based on the expected clearance time of the antibody from the body (approximately five half-lives).
It is not known whether risankizumab is excreted in human breast milk. Human IgG antibodies are known to be present in breast milk during the first few days after birth. A risk to the breastfed infant cannot be excluded. Discuss with your doctor whether to discontinue breastfeeding or to discontinue Skyrizi, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Driving and Using Machines
Skyrizi is not expected to affect your ability to drive or operate machinery. No studies on the effects on the ability to drive and use machines have been performed.
Important Information About Excipients
Skyrizi contains polysorbat 20 (0.24 mg per 180 mg dose; 0.48 mg per 360 mg dose), which may cause allergic reactions in some individuals. Inform your doctor if you have known allergies to polysorbates. The medicine also contains less than 1 mmol (23 mg) sodium per cartridge, meaning it is essentially sodium-free.
How Does Skyrizi Interact with Other Drugs?
Skyrizi has no known clinically significant drug-drug interactions with commonly used medications. The most important interaction is with live vaccines, which must be avoided during treatment. Always inform your healthcare provider about all medicines you are taking.
One of the advantages of risankizumab from a pharmacological standpoint is its favorable drug interaction profile. As a monoclonal antibody, risankizumab is not metabolized by cytochrome P450 (CYP) enzymes in the liver and does not interact with drug transporters, which are the most common sources of drug-drug interactions. This means that Skyrizi is unlikely to affect the blood levels of other medicines you may be taking, and vice versa.
However, there are some important considerations regarding concomitant treatments:
| Interacting Agent | Type | Effect | Recommendation |
|---|---|---|---|
| Live vaccines | Major | Risk of vaccine-strain infection due to immunosuppression | Avoid: Do not administer live or live-attenuated vaccines during treatment |
| Immunosuppressants (e.g., azathioprine, methotrexate) | Moderate | Potential additive immunosuppressive effect increasing infection risk | May be used together under specialist supervision; monitor for infections |
| Other biologics (e.g., TNF inhibitors, other IL inhibitors) | Major | Increased risk of immunosuppression and serious infections | Avoid: Combination with other biologic agents is not recommended |
| Inactivated vaccines | Minor | Immune response to vaccine may be slightly reduced | Can generally be administered; discuss timing with your doctor |
| CYP substrates (e.g., warfarin, statins, oral contraceptives) | None expected | No clinically significant interaction expected | No dose adjustment needed |
Although formal drug interaction studies with risankizumab are limited, population pharmacokinetic analyses have shown no clinically meaningful effects of concomitant corticosteroids, aminosalicylates (5-ASAs), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate) on risankizumab clearance. Nevertheless, always inform your doctor about every medication, herbal supplement, and over-the-counter product you are taking before starting Skyrizi.
What Is the Correct Dosage of Skyrizi?
Skyrizi treatment begins with three intravenous infusion doses (induction phase), followed by subcutaneous injection doses every 8 weeks (maintenance phase). The exact doses differ between Crohn's disease and ulcerative colitis. Always follow your doctor's instructions.
Skyrizi dosing follows a two-phase approach: an induction phase using intravenous (IV) infusions administered by a healthcare professional, followed by a maintenance phase using subcutaneous (SC) injections that may be self-administered at home after appropriate training. The dosing regimens differ between Crohn's disease and ulcerative colitis.
Induction Phase (IV Infusion)
The induction doses are given as intravenous infusions by your doctor or nurse at a healthcare facility. You cannot give these doses yourself.
| Indication | Dose | Schedule |
|---|---|---|
| Crohn's Disease | 600 mg IV | Weeks 0, 4, and 8 (three doses total) |
| Ulcerative Colitis | 1,200 mg IV | Weeks 0, 4, and 8 (three doses total) |
Maintenance Phase (Subcutaneous Injection)
After completing the induction phase, you transition to maintenance dosing with subcutaneous injections. Your healthcare team will train you on how to self-administer the injection using the on-body injector device with the cartridge.
| Indication | Dose | Schedule |
|---|---|---|
| Crohn's Disease | 360 mg SC | First dose at week 12, then every 8 weeks |
| Ulcerative Colitis | 180 mg or 360 mg SC | First dose at week 12, then every 8 weeks |
The choice between 180 mg and 360 mg for ulcerative colitis maintenance therapy is determined by your doctor based on your individual clinical response during the induction phase and disease severity.
How to Administer the Subcutaneous Injection
Skyrizi subcutaneous doses are given using a cartridge loaded into a single-use on-body injector (adhesive injector). The injection can be administered in the front of the thighs or the abdomen (at least 5 cm from the navel). Key steps include:
- Remove the carton from the refrigerator and allow it to reach room temperature for at least 45 minutes (up to 90 minutes) before injection. Do not warm it by any other means
- Inspect the solution: it should be clear to yellow and may contain small white or transparent particles. Do not use if cloudy or if it contains flakes or large particles
- Clean the injection site with an alcohol swab and allow it to dry
- Load the cartridge into the on-body injector, attach it to the cleaned skin, and press the start button
- The injection takes up to 5 minutes to complete. A green status light confirms completion
- Dispose of the used injector in a sharps container. It contains batteries, electronics, and a needle
Missed Dose
If you miss a dose of Skyrizi, inject your dose as soon as you remember, then continue your regular dosing schedule. Do not inject a double dose to make up for a forgotten one. Contact your doctor if you are unsure about what to do.
Overdose
If you have injected more Skyrizi than prescribed or if the dose was given earlier than scheduled, contact your doctor. In clinical trials, doses up to 1,800 mg intravenously and 360 mg subcutaneously were administered without dose-limiting toxicity. There is no specific antidote for risankizumab overdose; treatment should be supportive and symptom-directed.
Do not stop using Skyrizi without first talking to your doctor. If you discontinue treatment, your symptoms may return. Your doctor will help you determine the best course of action if treatment needs to be adjusted.
What Are the Side Effects of Skyrizi?
The most common side effects of Skyrizi are upper respiratory tract infections, fatigue, fungal skin infections, injection site reactions, itching, headache, rash, and eczema. Serious but rare side effects include anaphylaxis and serious infections. Most side effects are mild to moderate.
Like all medicines, Skyrizi can cause side effects, although not everybody gets them. The safety profile of risankizumab has been well-characterized through extensive clinical trials involving thousands of patients with inflammatory bowel disease, psoriasis, and psoriatic arthritis. Overall, Skyrizi is considered to have a favorable safety profile compared to many other biologic therapies, with most adverse events being mild to moderate in severity.
Below is a summary of the most commonly reported side effects, organized by their frequency of occurrence:
Very Common
May affect more than 1 in 10 people
- Upper respiratory tract infections (sore throat, nasal congestion, runny nose)
Common
May affect up to 1 in 10 people
- Fatigue (feeling tired)
- Fungal skin infections (tinea, candidiasis)
- Injection site reactions (redness, pain, swelling)
- Itching (pruritus)
- Headache
- Skin rash
- Eczema (dermatitis)
Uncommon
May affect up to 1 in 100 people
- Small raised red bumps on the skin (folliculitis)
- Hives (urticaria)
Rare
May affect up to 1 in 1,000 people
- Severe allergic reactions (anaphylaxis)
In clinical trials for Crohn's disease and ulcerative colitis, the overall infection rate was similar between risankizumab-treated patients and those receiving placebo. The incidence of serious infections was low and comparable across treatment groups. No new safety signals were identified in long-term extension studies of up to two years.
Contact your doctor or seek emergency care immediately if you experience:
- Signs of a serious allergic reaction: difficulty breathing or swallowing, swelling of face/lips/tongue/throat, dizziness or feeling faint
- Signs of a serious infection: fever, flu-like symptoms, night sweats, persistent cough, warm/red/painful skin, painful rash with blisters
Your doctor will decide whether you can continue using Skyrizi.
It is important to report any suspected side effects to your healthcare provider. Pharmacovigilance reporting helps regulatory agencies continuously monitor the benefit-risk balance of all approved medicines.
How Should You Store Skyrizi?
Store Skyrizi in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. If needed, it can be stored at room temperature (up to 25°C / 77°F) for up to 24 hours. Keep in the original packaging to protect from light.
Proper storage of Skyrizi is essential to maintain the stability and effectiveness of the medicine. Follow these storage guidelines carefully:
- Refrigerate: Store cartridges in the refrigerator at 2°C to 8°C (36°F to 46°F). This is the recommended long-term storage condition
- Do not freeze: Never freeze Skyrizi. If the solution has been frozen, even if subsequently thawed, it must not be used
- Room temperature storage: If necessary, the cartridge can be stored outside the refrigerator at up to 25°C (77°F) for a maximum of 24 hours. After this period, any unused medicine must be discarded
- Protect from light: Keep the cartridge in the original carton until ready for use to protect it from light
- Do not shake: Avoid shaking the carton, cartridge, or on-body injector
- Visual inspection: Before use, check that the solution is clear to yellow. Small white or transparent particles are normal. Do not use if the solution is cloudy, discolored, or contains flakes or large particles
- Expiration: Do not use Skyrizi after the expiration date (EXP) printed on the cartridge label and outer carton
- Keep out of reach of children
The on-body injector is for single use only. It contains batteries and electronics in addition to the needle. Dispose of the used injector in a designated sharps disposal container immediately after use. Do not throw it in household waste. Ask your pharmacist about local disposal guidelines.
What Does Skyrizi Contain?
Each Skyrizi cartridge contains either 180 mg or 360 mg of risankizumab as the active ingredient, along with inactive ingredients including sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections.
180 mg Cartridge
Each cartridge contains 180 mg risankizumab in 1.2 mL solution. The inactive ingredients (excipients) are:
- Sodium acetate trihydrate (buffering agent)
- Acetic acid (pH adjuster)
- Trehalose dihydrate (stabilizer)
- Polysorbate 20 (surfactant)
- Water for injections (solvent)
360 mg Cartridge
Each cartridge contains 360 mg risankizumab in 2.4 mL solution. The inactive ingredients are identical to those in the 180 mg cartridge.
Appearance and Packaging
Skyrizi solution for injection is a clear and colorless to yellowish liquid in a cartridge. The solution may contain small white or transparent particles, which is normal. Each package contains one cartridge and one single-use on-body injector (adhesive injector).
Skyrizi is manufactured by AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, and is distributed globally by AbbVie affiliates.
Frequently Asked Questions About Skyrizi
Skyrizi (risankizumab) is used to treat adults with moderate to severe Crohn's disease and moderate to severe ulcerative colitis. It is also approved for moderate to severe plaque psoriasis and active psoriatic arthritis. Skyrizi is typically prescribed when conventional therapies (such as corticosteroids, aminosalicylates, or immunomodulators) have not worked well enough, or when a patient has lost response to or cannot tolerate other biologic treatments.
Skyrizi works by selectively blocking interleukin-23 (IL-23), a protein in the body that plays a key role in driving inflammation. IL-23 activates immune cells called T-helper 17 (Th17) cells, which produce inflammatory cytokines that damage the intestinal lining. By binding to the p19 subunit of IL-23 and preventing it from interacting with its receptor, risankizumab reduces this inflammatory cascade and helps the gut lining to heal.
The most common side effects of Skyrizi include upper respiratory tract infections (such as sore throat and nasal congestion, affecting more than 1 in 10 patients), fatigue, fungal skin infections, injection site reactions (redness or pain), itching, headache, skin rash, and eczema. Most of these side effects are mild to moderate and manageable. Serious side effects such as anaphylaxis and serious infections are rare.
Skyrizi treatment has two phases. The induction phase consists of three intravenous (IV) infusion doses given at weeks 0, 4, and 8 by a healthcare professional. After the induction phase, the maintenance phase begins at week 12 with subcutaneous (under the skin) injections every 8 weeks using a single-use on-body injector with a cartridge. After appropriate training from your healthcare team, you can self-administer the subcutaneous injections at home.
There is limited data on Skyrizi use during pregnancy, and it is not known whether risankizumab can harm an unborn baby. As a precaution, women who can become pregnant should use effective contraception during treatment and for at least 21 weeks after the last dose. It is not known whether risankizumab passes into breast milk. Discuss with your doctor whether to continue breastfeeding or Skyrizi treatment, weighing the benefits of each.
You should not receive live or live-attenuated vaccines while being treated with Skyrizi, as the medicine suppresses part of the immune system and there is a risk of infection from the vaccine strain. Inactivated vaccines can generally be given during treatment, although the immune response may be slightly reduced. It is recommended to complete all age-appropriate vaccinations before starting Skyrizi therapy. Discuss your vaccination schedule with your healthcare provider.
References
This article is based on the following peer-reviewed sources and regulatory documents:
- European Medicines Agency (EMA). Skyrizi (risankizumab) – Summary of Product Characteristics. Last updated October 2025. Available at: ema.europa.eu/en/medicines/human/EPAR/skyrizi
- U.S. Food and Drug Administration (FDA). SKYRIZI (risankizumab-rzaa) – Prescribing Information. Revised 2025. Reference ID: 5359922.
- D'Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. The Lancet. 2022;399(10340):2015-2030. doi:10.1016/S0140-6736(22)00466-4
- Ferrante M, Panaccione R, Baert F, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. The Lancet. 2022;399(10340):2031-2046. doi:10.1016/S0140-6736(22)00466-4
- Louis E, Schreiber S, Engel T, et al. Risankizumab for ulcerative colitis: phase 3 INSPIRE induction and COMMAND maintenance trials. New England Journal of Medicine. 2024;391(14):1283-1296.
- Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. The Lancet. 2017;389(10080):1741-1755. doi:10.1016/S0140-6736(16)31711-1
- European Crohn's and Colitis Organisation (ECCO). ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. Journal of Crohn's and Colitis. 2024;18(10):1531-1555.
- American Gastroenterological Association (AGA). AGA Clinical Practice Guideline on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2024;166(4):521-542.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. 2023.
- British National Formulary (BNF). Risankizumab. National Institute for Health and Care Excellence (NICE). Accessed January 2026.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, consisting of licensed physicians and pharmacologists with specialist expertise in gastroenterology, inflammatory bowel disease, and clinical pharmacology.
iMedic Medical Editorial Team – specialists in gastroenterology and clinical pharmacology with documented academic background and clinical experience in inflammatory bowel disease management.
iMedic Medical Review Board – independent panel of medical experts who review all content according to international guidelines (EMA, FDA, ECCO, AGA). Evidence grading follows the GRADE framework.
Editorial Standards: All drug information on iMedic is based on approved regulatory documents (EMA SmPC, FDA Prescribing Information) and peer-reviewed clinical trial data. Content is reviewed and updated at least annually or when significant new safety information becomes available. We maintain strict editorial independence with no pharmaceutical industry funding or influence. Read our full editorial policy.