Overview: Skyrizi is used for plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease. Common side effects vary but may include infection in the nose or throat, headache, joint pain, or rash. Tell your health care provider right away if you get an infection, especially if you have a fever, cough, or shortness of breath. While rare, this medicine may damage the liver, so also tell your health care provider right away if you have stomach pain, nausea and vomiting, loss of appetite, or a yellowish color to your skin or the whites of your eyes. Skyrizi is given as an injection under the skin or an infusion into a vein.
Uses
What is Skyrizi used for?
Skyrizi (risankizumab) is commonly used for the following conditions.
- Moderate to severe Crohn’s disease
- Moderate to severe ulcerative colitis (UC)
- Moderate to severe plaque psoriasis
- A type of arthritis that occurs in people with psoriasis (psoriatic arthritis)
How Skyrizi Works for Crohn’s Disease
How Skyrizi Works for Plaque Psoriasis
How Skyrizi Works for Psoriatic Arthritis
Skyrizi may also be used for other conditions as determined by your health care provider.
How does Skyrizi work (mechanism of action)?
Skyrizi blocks a substance in the body called interleukin-23 (IL-23) from working. People with certain conditions have too much IL-23. Blocking IL-23 can decrease the swelling (inflammation) that causes these conditions.
How is Skyrizi supplied (dosage forms)?
Brands and other names
- Skyrizi
Dosage forms and strengths
- 55 mg/0.37 mL, 90 mg/mL, 150 mg/mL, 180 mg/1.2 mL single-dose prefilled syringe
- 150 mg/mL single-dose prefilled pen
- 180 mg/1.2 mL, 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector
- 600 mg/10 mL (60 mg/mL) solution for injection (vial)
How should I store Skyrizi?
Vial. Skyrizi vials are usually given by a health care provider in a hospital or clinic. If you will store Skyrizi vials at home, follow the instructions given by your health care provider.
Prefilled Pen, Syringe, or Cartridge. Skyrizi should be kept in its original carton to protect it from light. It must be stored in the refrigerator, between 36 F and 46 F (2 C and 8 C). Do not shake or freeze the medicine.
Side Effects
What are the most common side effects of Skyrizi?
The most common side effects of Skyrizi are listed below. These side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.
- Infection in the nose or throat, sore throat, or common cold symptoms
- Headache
- Joint pain, back pain, or stomach pain
- Pain, itching, swelling, or redness near the injection site
- Fever
- Low levels of red blood cells (anemia)
- Rash
- Tiredness
- Skin or bladder infection
There may be other side effects of Skyrizi that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Skyrizi?
While less common, the most serious side effects of Skyrizi are described below, along with what to do if they happen.
Severe Allergic Reactions. Skyrizi may cause allergic reactions, which can be serious. Stop using Skyrizi and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Infection. Skyrizi can increase the risk of infections, including serious infections. It can also make current infections worse. Call your health care provider if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Cough or coughing up blood
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Warm, red, or painful skin
- Weight loss
Liver Damage. Liver damage, also called hepatotoxicity, can happen when using Skyrizi. This may be more likely to happen in people with inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis. Call your health care provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Warnings & Precautions
Who should not use Skyrizi?
Allergies to Ingredients. People who are allergic to any of the following should not use Skyrizi.
- Risankizumab
- Skyrizi
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Skyrizi.
What should I know about Skyrizi before using it?
Do not use Skyrizi unless it has been prescribed to you by a health care provider. Use it as prescribed.
Do not share Skyrizi with other people, even if they have the same condition as you. It may harm them.
Keep Skyrizi out of the reach of children. Since this medicine must be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.
This medicine is usually injected under the skin. Make sure that you or a caregiver understands how to properly prepare and use Skyrizi. If you have any questions, talk to your health care provider.
Skyrizi may be taken out of the refrigerator shortly before use to allow it to reach room temperature (15 to 30 minutes before using the prefilled syringe and 30 to 90 minutes before using the prefilled pen). Do not use your hands or any heat sources to warm the medicine. Keep Skyrizi in its original carton until use to protect it from light. Keep it out of direct sunlight.
What should I tell my health care provider before using Skyrizi?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Skyrizi is right for you.
In particular, make sure that you discuss any of the following.
Infections. Before starting Skyrizi, it is important to talk to your health care provider about any serious infections you have had in the past, as well as any infections you have currently. You should also let your health care provider know if you have any of the following, which might increase your chance of having an infection while using Skyrizi.
- History of tuberculosis (TB)
- Been in close contact with someone who has tuberculosis (TB)
- Living in, have lived in, or traveled to countries where there is a risk for TB
- Weak immune system
- An infection that keeps coming back
Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Skyrizi. Tell your health care provider about any vaccines you have recently received or have scheduled.
Pregnancy. It is not known if or how Skyrizi could affect pregnancy or harm a fetus. Tell your health care provider if you are or plan to become pregnant. Your health care provider will let you know if you should use Skyrizi while you are pregnant or trying to get pregnant. If you become pregnant while using Skyrizi, you can register for the pregnancy registry by calling 877-302-2161 or at www.glowpregnancyregistry.com. This registry collects safety information about the use of Skyrizi during pregnancy.
Breastfeeding. It is not known if Skyrizi passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Skyrizi while breastfeeding.
How can I get more information about Skyrizi?
For more information about Skyrizi, you can visit the drugmaker’s website at www.skyrizi.com or call them at 866-SKYRIZI (866-759-7494).
Interactions
Does Skyrizi interact with foods or drinks?
There are no known interactions between Skyrizi and foods or drinks.
It is unknown if drinking alcohol will affect Skyrizi.
Does Skyrizi interact with other medicines (drug interactions)?
There are no known interactions between Skyrizi and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Overdose/Missed Dose
What should I do if I accidentally use too much Skyrizi?
If you or someone else has used too much Skyrizi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Skyrizi?
If you miss a dose, use Skyrizi as soon as you remember. You can then use your next dose at the normal time. Do not use double or extra doses.
If you miss an appointment with your health care provider to receive a dose of Skyrizi, call them as soon as possible to reschedule.
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