Risankizumab

Risankizumab-rzaa (brand name Skyrizi) is a biologic medication and selective IL-23 inhibitor used to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis in patients 6 years and older, and Crohn's disease and ulcerative colitis in adults. Risankizumab works by blocking interleukin-23 (IL-23), a protein that drives inflammation, which helps calm the immune system and reduce symptoms of these autoimmune diseases.

Risankizumab maintenance doses are given as a subcutaneous injection every 12 weeks for plaque psoriasis and psoriatic arthritis, or every 8 weeks for Crohn's disease and ulcerative colitis. Initial dosing may be given as an injection under the skin (subcutaneous injection) or intravenous infusion, depending on the condition being treated.

Risankizumab (Skyrizi) was first approved by the FDA on April 23, 2019, for moderate-to-severe plaque psoriasis. The indication has since expanded to include Crohn's disease, ulcerative colitis, and psoriatic arthritis. The most recent expansions were on June 12, 2026 (moderate-to-severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy) and June 26, 2026 (active psoriatic arthritis in patients 6 years and older).

Risankizumab is FDA-approved to treat:

• Plaque Psoriasis: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy
• Psoriatic Arthritis: active psoriatic arthritis in adults and children 6 years and older.
• Crohn’s Disease: moderately to severely active Crohn's disease in adults.
• Ulcerative colitis: moderately to severely active ulcerative colitis in adults.

Risankizumab's mechanism of action is by binding to the protein IL-23 (interleukin-23), a protein involved in inflammation in these conditions. By blocking IL-23, Skyrizi helps reduce inflammation, which improves the skin symptoms, joint symptoms, and Crohn’s disease and ulcerative colitis symptoms.

Skyrizi is a biologic medicine that belongs to a class of medications called interleukin-23 antagonists.

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

For adults and children 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis, risankizumab is given as an injection under the skin (subcutaneous injection) using a prefilled pen or prefilled syringe.

For ulcerative colitis in adults, the starting doses are given through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider.

For Crohn’s disease in adults, the induction doses are given either by intravenous infusion in a healthcare facility, or as injections under the skin using the Crohn’s disease induction pack. Each induction dose from the pack uses two on-body injectors.

After the induction doses, maintenance doses for Crohn’s disease and ulcerative colitis are given as injections under the skin, using either the prefilled cartridge with on-body injector or the 180 mg prefilled syringe.

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 or prefilled syringe.

Subcutaneous injections can be given at home after proper training from a healthcare provider. Your first self-injected dose should be given with a healthcare provider supervising.

• Adults can self-administer the subcutaneous injection
• 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.

Risankizumab Instructions:

Your healthcare provider should show you how to inject risankizumab 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 risankizumab 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 Skyrizi that has been frozen, dropped, or damaged.

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

Allergic reactions (hypersensitivity reactions) Serious allergic reactions, including life-threatening anaphylaxis, can occur with risankizumab (Skyrizi). Get emergency medical help right away if you have symptoms such as difficulty breathing, swelling of the face or throat, or a severe rash.

Risk of infections Skyrizi can increase your risk of getting infections. 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. Your doctor will not give you Skyrizi while you have an active infection.

Tuberculosis (TB) screening Your doctor will test you for tuberculosis (TB) before you start Skyrizi.

Liver problems (hepatotoxicity) Liver injury has been reported in people receiving Skyrizi for Crohn’s disease and ulcerative colitis during the initial treatment phase. Your doctor will check your liver enzymes and bilirubin levels before you start treatment and regularly for at least the first 12 weeks. Ongoing monitoring will continue as part of your routine care.

Vaccinations Do not receive live vaccines while being treated with Skyrizi. Talk to your doctor about which vaccines are safe to get before starting treatment.

To make sure risankizumab 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 children younger than 6 years old with active psoriatic arthritis or moderate-to-severe plaque psoriasis. It is not approved for use in people under the age of 18 who have ulcerative colitis or Crohn's 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 the health of you and your baby. Talk to your healthcare provider to enroll in this registry.

Breastfeeding

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

Common risankizumab side effects

Common side effects of risankizumab may include:

• fever, headache, tiredness;
• stomach pain, joint pain, back pain;
• cold symptoms such as stuffy nose, sneezing, and 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.

Serious risankizumab side effects

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

Allergic reactions

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.

Tuberculosis (TB) screening

Before starting Skyrizi, your doctor will check you for infections and tuberculosis (TB). If you have a history of TB or currently have active TB, your doctor may treat you for TB before beginning Skyrizi. Your doctor will also monitor you for signs and symptoms of TB during and after your treatment.

Infections

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.

Liver toxicity

Liver toxicity (hepatotoxicity) can occur with this medicine when used for the treatment of Crohn’s disease or ulcerative colitis. Call your doctor at once if you have symptoms of liver problems:

• 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 types of side effects from this medicine may vary depending on the condition you are taking it for.

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.

Usual dose for plaque psoriasis in adults:

Use: To treat 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.

Usual dose for plaque psoriasis in children 6 years and older:

Use: For the treatment of children 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Dose: The recommended dose is administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. The recommended dosage is based on body weight.

• Less than 40 kg is 55 mg.
• 40 kg or greater is 150 mg.

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

Usual dose for active psoriatic arthritis in children 6 years and older

Use: For the treatment of children 6 years and older with active psoriasis.

Dose: The recommended dose is administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. The recommended dosage is based on body weight.

• Less than 40 kg is 55 mg.
• 40 kg or greater is 150 mg.

Usual adult dose for risankizumab Crohn's disease:

Use: To treat moderately to severely active Crohn's disease in adults.

Induction dosage: one of the following:

• 600 mg given by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8, or
• 720 mg given by subcutaneous injection at Week 0, Week 2, Week 4, and Week 8

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

Usual adult dose for risankizumab 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 at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain a therapeutic response.

Subcutaneous Injection (Skyrizi brand)

Skyrizi Pen

• 150 mg/mL as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled pen.

Skyrizi Prefilled Syringe

• 180 mg/1.2 mL (150 mg/mL) in each single-dose prefilled syringe.
• 150 mg/mL single-dose prefilled syringe.
• 55 mg/0.37 mL in each single-dose prefilled syringe.

Skyrizi Prefilled Cartridge with Supplied On-Body Injector

• Injection: 360 mg/2.4 mL (150 mg/mL) as a colorless to yellow, and clear to slightly opalescent solution in each single-dose prefilled cartridge for use with the on-body injector.
• Injection: 180 mg/1.2 mL (150 mg/mL) as a colorless to yellow, and clear to slightly opalescent solution in each single-dose prefilled cartridge for use with the on-body injector.

Dose administration subcutaneous

The dose and number of syringes you need depend on which Skyrizi product your doctor has prescribed.

Follow the Instructions for Use provided with your medication.

Skyrizi 180 mg/1.2 mL syringes You or your caregiver can give this dose at home. The number of syringes depends on your condition:

• One syringe (180 mg total) maintenance dose
• Two syringes (360 mg total) maintenance dose

Intravenous Infusion

Skyrizi Vial

• Injection: 600 mg/10 mL (60 mg/mL) as a colorless to slightly yellow, and clear to slightly opalescent solution in each single-dose vial.

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.

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

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).

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.

Review the Risankizumab Package Insert (Skyrizi Package Insert) for more detailed information about this medicine. The Risankizumab PI contains more detailed information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. 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 Risankizumab Prescribing Information (PI) or Risankizumab FDA label.

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

• Store in the refrigerator between 36°F and 46°F (2°C and 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 and 46°F (2°C and 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.

Active ingredient: risankizumab-rzaa.

Inactive ingredients in Skyrizi 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: glacial acetic acid, polysorbate 20, sodium acetate, trehalose, and Water for Injection, USP.

Skyrizi is not made with natural rubber latex.

Skyrizi Manufacturer is AbbVie Inc.