Pronunciation: sky-RIZZ-ee
Generic name: risankizumab [ RIS-an-KIZ-ue-mab ]
Dosage form: vial, autoinjector pen, prefilled syringe, prefilled cartridge (supplied on-body injector)
Drug class: Interleukin inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 16, 2025.

What is Skyrizi?

Skyrizi (risankizumab) is a prescription biologic medication used to treat plaque psoriasis, psoriatic arthritis, ulcerative colitis, or Crohn’s disease, which are chronic inflammatory diseases. Skyrizi helps clear psoriasis skin symptoms and also improves inflammation, joint pain, and gastrointestinal symptoms in other conditions. Skyrizi works by targeting and blocking IL-23 (interleukin-23), a protein in the immune system that plays a key role in causing inflammation.

Skyrizi is a interleukin-23 antagonist. 

Skyrizi is administered as an injection under the skin (subcutaneous injection) or as an intravenous infusion, depending on the specific condition. Maintenance doses are typically given every 8 to 12 weeks after a series of initial loading doses.

Skyrizi FDA approval was first granted on April 23, 2019, for moderate to severe plaque psoriasis, following results from the ultIMMa-1 (NCT02684370) and ultIMMa-2 (NCT02684357) Phase 3 clinical trials. It was developed by AbbVie, a global, research and development-based biopharmaceutical company

Who can use Skyrizi?

Skyrizi is FDA-approved for use in adults with:

• Moderate-to-severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy
• Active psoriatic arthritis
• Moderately to severely active Crohn’s disease
• Moderately to severely active ulcerative colitis

How does Skyrizi work?

Skyrizi mechanism of action is by binding and blocking IL-23 (interleukin-23), a cytokine (protein) involved in inflammation and immune responses. By binding to the p19 subunit of IL-23, Skyrizi blocks its activity, reducing inflammation. This leads to improvement in skin lesions, joint pain, and gastrointestinal symptoms associated with autoimmune conditions.

How well does Skyrizi work?

Clinical trials have demonstrated the efficacy of Skyrizi across its approved indications.

How effective is Skyrizi for plaque psoriasis? 

• 75% of Skyrizi patients achieved clear or almost clear skin (PASI 90) after 16 weeks of treatment. Clinical studies ultIMMa-1 (NCT02684370) and ultIMMa-2 NCT02684357.
• 82% of patients achieved clear or almost clear skin (PASI 90) after 52 weeks in clinical studies ultIMMa-1.
• 60% of patients achieved clear skin (PASI 100) after 52 weeks in the clinical study ultIMMa-2.

How effective is Skyrizi for psoriatic arthritis?

• Skyrizi showed a statistically significant improvement in physical function at week 24, compared to placebo in the KEEPsAKE-1 (NCT03675308) and KEEPsAKE-2 (NCT03671148) clinical trials.

How effective is Skyrizi for Crohn's disease?

• For Crohn's disease, many patients experienced remission and mucosal healing as early as 12 weeks into therapy, with sustained benefits at one year, in the clinical trials ADVANCE (NCT03105128) and MOTIVATE (NCT03104413). These results underscore its effectiveness in managing chronic inflammatory conditions, especially for patients who have not responded to other treatments.

How effective is Skyrizi for ulcerative colitis?

• 36% of Skyrizi patients had an endoscopic improvement after a 12-week UC-1 induction study (NCT03398148), 

Skyrizi side effects

Common Skyrizi side effects

Common side effects of Skyrizi may include:

• fever, headache, tiredness
• stomach pain, joint pain, back pain
• cold symptoms such as a stuffy nose, sneezing, sore throat
• pain and burning when you urinate (urinary tract infection)
• fungal skin infection;
• low red blood cells (anemia) with symptoms of feeling faint or dizzy, unusually weak or tired,  having falls, or trouble breathing
• injection site reaction, including pain, bruising, swelling, or irritation where the medicine was injected.

Related/similar drugs

Serious Skyrizi side effects

Skyrizi may cause serious side effects, including allergic reactions, severe infections, and liver problems.

Get emergency medical help if you have signs of an allergic reaction with symptoms of hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection, including:

• fever, night sweats, chills, sore throat
• mouth sores, red or swollen gums
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also, call your doctor at once if you have:

• nausea, vomiting, skin rash , or
• liver problems with symptoms of stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), and loss of appetite..

The number of people who get side effects and the types of side effects from Skyrizi may vary depending on what condition you are taking it for. Hepatotoxicity is a warning when it is used for the treatment of inflammatory bowel disease.

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.

Warnings

Skyrizi affects your immune system and you may get infections more easily, they may be serious and even  Call your doctor right away if you have signs of infection such as: fever, chills, sweats, muscle aches, skin sores, stomach pain, diarrhea, burning when you urinate, weight loss, cough, shortness of breath, or a cough with red or pink mucus.

Skyrizi can increase the risk of tuberculosis infections. Patients should be screened for TB before starting therapy.

This medicine should not be used if you are allergic risankizumab-rzaa, Skyrizi, or any of the ingredients in this medicine. See below for a full list of ingredients.

Hepatotoxicity can occur in patients being treated for inflammatory bowel disease. Your liver enzymes and bilirubin levels will be monitored at baseline and, during induction, up to at least 12 weeks of treatment.

Avoid the use of live vaccines when being treated with this medicine. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Before starting Skyrizi treatment, complete all age-appropriate vaccinations according to current immunization guidelines. 

Before taking this medicine

To make sure this medicine is safe for you, tell your doctor if you: 

• have an active or chronic infection.
• have had or have been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.
• have or have ever had liver disease, including cirrhosis, or any other medical conditions.
• have recently received a vaccine or are scheduled for a booster dose. Make sure you are current on all vaccines before you start using this medicine.

This medicine is not approved for use by anyone younger than 18 years old.

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 the health of you and your baby. Talk to your healthcare provider 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. 

How should I use Skyrizi?

Use Skyrizi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Plaque psoriasis or psoriatic arthritis. Skyrizi is given as an injection under the skin (subcutaneous injection) using a prefilled pen or prefilled syringe.

Crohn’s disease and ulcerative colitis. The starter (induction) doses are given through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. After completing the starter doses, patients will receive this medicine as an injection under the skin (subcutaneous injection) using the prefilled cartridge with the on-body injector.

Skyrizi Instructions:

Your healthcare provider should show you how to inject Skyrizi before self-injecting with the prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector. Your healthcare provider will also show you where to inject this medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.

Take the carton containing the medicine out of the refrigerator and leave it in the carton. Place it on a flat surface, out of direct sunlight, to let it reach room temperature. Times for each device:

• Single-dose pen is 30 to 90 minutes.
• Single-dose prefilled syringe is 15 to 30 minutes. 
• Prefilled cartridge with an on-body injector is at least 45 minutes up to 90 minutes.

Do not heat the medicine in a microwave or with hot water.

Do not use if the liquid has been frozen (even if thawed).

Check the medicine, it should be clear or light yellow. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

You can inject anywhere on the front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If someone else is giving you the injection using the syringe or pen, that person can also inject the medication into your upper, outer arms.

Use a different site for each injection to reduce the chances of soreness or redness. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have psoriasis, scars or stretch marks.

Do not shake the syringe, pen, on-body injector, or prefilled cartridge.

Do not remove the needle cover from the syringe or the needle cap from the prefilled pen until you are ready to inject the medication.

Inject Skyrizi according to package instructions.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Throw away a prefilled syringe or injection pen after one use, even if there is still medicine left inside.

Throw away any injection that has been frozen, dropped, or damaged.

You may get infections more easily, even serious infections. You will need frequent medical tests.

For more detailed instructions, including diagrams for all Skyrizi device types, see Skyrizi Instructions For Use.

Skyrizi dosing information

Usual adult Skyrizi dose for plaque psoriasis

Use: For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Dose: 150 mg subcutaneously at Week 0, Week 4, and every 12 weeks thereafter

Comments: Evaluate patients for tuberculosis (TB) infection before initiating this drug.

Usual adult dose for psoriatic arthritis

Use: For the treatment of active psoriatic arthritis in adults

Dose: 150 mg subcutaneously at Week 0, Week 4, and every 12 weeks thereafter

Comments: Evaluate patients for tuberculosis (TB) infection prior to initiating this drug.

Usual adult dose for Crohn's disease

Use: For the treatment of moderately to severely active Crohn's disease in adults.

Induction dosage: 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8.
Maintenance dosage: 360 mg administered by subcutaneous injection using the prefilled cartridge with on-body injector or prefilled syringes, at Week 12, and every 8 weeks thereafter.

Comments: Evaluate patients for tuberculosis (TB) infection prior to initiating this drug. Obtain liver enzymes and bilirubin levels before initiating treatment with this drug.

Usual adult dose for ulcerative colitis

Use: For the treatment of moderately to severely active ulcerative colitis in adults.

Induction dosage: 1200 mg administered by intravenous infusion over at least two hours at Week 0, Week 4, and Week 8.

Maintenance dosage: 180 mg or 360 mg administered by subcutaneous injection using the prefilled cartridge with on-body injector or prefilled syringes at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain a therapeutic response.

Comments: Evaluate patients for tuberculosis (TB) infection before initiating this drug. Obtain liver enzymes and bilirubin levels before initiating treatment with this drug.

Skyrizi dosage forms

Subcutaneous injection 

Skyrizi Pen

• 150 mg/mL in each single-dose prefilled pen.

Skyrizi prefilled syringe

• 90 mg/mL in each single-dose prefilled syringe.
• 150 mg/mL in each single-dose prefilled syringe.

Skyrizi Prefilled Cartridge with Supplied On-Body Injector 

• 180 mg/1.2 mL (150 mg/mL) in each single-dose prefilled cartridge.
• 360 mg/2.4 mL (150 mg/mL) in each single-dose prefilled cartridge.

Intravenous infusion 

Skyrizi Vial

• 600 mg/10 mL (60 mg/mL) in each single-dose vial for infusion.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

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

What should I avoid while using this medicine?

Avoid receiving a "live" vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect this medicine?

Other drugs may interact with risankizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Skyrizi Package Insert 

HCPs and patients often use the Skyrizi Package Insert (PI) for more detailed information about this medicine. The Package Insert (prescribing information) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called the Skyrizi Prescribing Information (PI) or FDA label.

Skyrizi J code

The Skyrizi J code is J2327 
J codes are used for medicines that are not taken orally and include injections, inhalations, and chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.

Your physician will need Skyrizi J code when filling out forms for your treatment.

Storage

Storage of Skyrizi Pen, Vial, Prefilled Syringe, and Prefilled Cartridge with Supplied On-Body Injector:

• Store in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze. 
• Do not shake.
• Keep this medicine in the original carton to protect it from light.

Storage of Skyrizi Diluted Solution for infusion:

• Infuse the diluted solution intravenously over a period of at least one hour. Complete the infusion within 8 hours of dilution.
• If not used immediately, store the diluted solution refrigerated and protected from light for up to 20 hours between 36°F to 46°F (2°C to 8°C). 
• Subsequently, the diluted solution can be stored (protected from direct and indirect sunlight) for 8 hours at room temperature at up to 77°F (25°C) after dilution (cumulative time after preparation including the storage and the infusion period). 
• Do not freeze.

Ingredients

Active ingredient: 

• risankizumab-rzaa.

Inactive ingredients: 

• Skyrizi 150 mg/mL, 180 mg/1.2 mL, 360 mg/2.4 mL, and 600 mg/10 mL: glacial acetic acid, polysorbate 20, sodium acetate, trehalose, and Water for Injection, USP.
• Skyrizi 75 mg/0.83 mL and 90 mg/mL: sodium succinate, polysorbate 20, sorbitol, succinic acid, and Water for Injection, USP.

This medicine is not made with natural rubber latex.

Company

Skyrizi by AbbVie Inc., North Chicago, IL 60064, U.S.A. 

Skyrizi Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Skyrizi.

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Further information

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