Risankizumab

Pronunciation: RIS-an-KIZ-ue-mab
Brand name: Skyrizi (sky-RIZZ-ee)
Dosage form: Vial (600 mg/10 mL), Pen (150 mg/mL), Prefilled Syringe(75 mg/0.83 mL ; 150 mg/mL), Prefilled Cartridge with Supplied On-Body Injector(180 mg/1.2 mL ; 360 mg/2.4 mL)
Drug class: Interleukin inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 15, 2024.

What is risankizumab?

Risankizumab-rzaa (Skyrizi) is a medication used to treat adults with certain types of plaque psoriasis, psoriatic arthritis, ulcerative colitis or Crohn’s disease, which are all autoimmune disorders. Risankizumab mechanism of action (MOA) is by targeting a specific protein in the immune system called interleukin-23 (IL-23), which is responsible for causing inflammation in these conditions. Risankizumab helps reduce inflammation, which improves the symptoms of these conditions, by attaching to and blocking IL-23.

Risankizumab brand name is Skyrizi.

Risankizumab-rzaa is a monoclonal antibody that belongs to a class of medications called interleukin-23 antagonists. Skyrizi is given as a subcutaneous injection for plaque psoriasis and psoriatic arthritis. For ulcerative colitis and Crohn’s disease, it is given as an intravenous infusion for the induction period, then as a subcutaneous injection for maintenance dosing.

Who can use risankizumab?

Risankizumab is FDA-approved to treat:

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

Risankizumab (Skyrizi) FDA approval was granted on Apr 23, 2019, for moderate to severe plaque psoriasis and since then the approval has been extended to cover Crohn’s disease, ulcerative colitis, and psoriatic arthritis.

 Risankizumab side effects 

Common risankizumab side effects

Common risankizumab side effects are cold symptoms such as stuffy nose, sneezing, sore throat, headache, feeling tired, fungal skin infections, and injection site reactions when used for plaque psoriasis and psoriatic arthritis.

Common risankizumab side effects are fever, headache, stomach (abdominal) pain, back pain, joint pain, cold symptoms, injection site reactions, pain, redness, itching, and low red blood cell levels (anemia) when used for Crohn’s disease.

Common risankizumab side effects are rash, joint pain, fever, injection site reactions, pain, swelling, bruising itching when used for ulcerative colitis.

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

Serious risankizumab side effects

Risankizumab may cause serious side effects, including severe allergic reactions. Get emergency medical help if you have signs of an allergic reaction 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, such as:

• 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--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
  
  

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

Elevations in lipid levels and the development of antibodies to risankizumab have also been reported. 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

Risankizumab affects your immune system, and you may get infections more easily. 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.

This medicine should not be used if you are allergic to risankizumab-rzaa or any of the ingredients in this medicine, for a full list of ingredients, see the Ingredients section at the end of this page.

Before taking this medicine

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 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 risankizumab, 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 risankizumab?

Use risankizumab 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. Risankizumab is given as an injection under the skin (subcutaneous injection) using a prefilled pen or prefilled syringe.

Risankizumab Crohn’s disease and ulcerative colitis. The starter 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.

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.

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, click on this link: Skyrizi Instructions For Use.

Risankizumab Dosing information

Usual adult dose for plaque psoriasis:

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

Comments: Evaluate patients for tuberculosis (TB) infection prior to 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 risankizumab Crohn's disease:

Use: To treat 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, 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 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.

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

Related/similar drugs

Entyvio, Otezla, Sotyktu, Cimzia, Stelara, prednisone, methotrexate, dexamethasone, budesonide, Humira

Risankizumab dosage forms

Subcutaneous Injection (Skyrizi brand)

Skyrizi Pen

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

Skyrizi Prefilled Syringe

• Injection: 150 mg/mL as a colorless to yellow and clear to slightly opalescent solution in each single-dose prefilled syringe.
• Injection: 90 mg/mL as a colorless to slightly yellow and clear to slightly opalescent solution in each single-dose prefilled syringe.
• Injection: 75 mg/0.83 mL as a colorless to slightly yellow and clear to slightly opalescent solution 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.

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.

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 risankizumab?

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 risankizumab?

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.

Risankizumab Package Insert

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

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

Skyrizi is not made with natural rubber latex.

Risankizumab Manufacturer

Skyrizi Manufacturer is AbbVie Inc.

Risankizumab 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 risankizumab.

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