Generic name: risankizumab [ RIS-an-KIZ-ue-mab ]
Drug class: Interleukin inhibitors
What is Skyrizi?
Skyrizi is an interleukin-23 antagonist. Interleukin-23 triggers an inflammatory response in the skin.
Skyrizi is a prescription medicine used to treat moderate to severe plaque psoriasis in adults who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
Skyrizi is used to treat active psoriatic arthritis in adults.
Skyrizi is also used to treat moderate to severe Crohn’s disease in adults.
It is not known if Skyrizi is safe and effective in children under 18 years of age.
Warnings
Skyrizi affects your immune system. 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.
Before taking this medicine
Tell your doctor if you have an active or chronic infection.
Tell your doctor if you've had or 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.
Tell your doctor if you recently received a vaccine or are scheduled for a booster dose.
Make sure you are current on all vaccines before you start using Skyrizi.
Tell your doctor if you are pregnant or breastfeeding.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risankizumab on the baby.
Not approved for use by anyone younger than 18 years old.
How should I use Skyrizi?
Take Skyrizi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Adults with plaque psoriasis or psoriatic arthritis will receive Skyrizi as an injection under the skin (subcutaneous injection) using the prefilled pen or prefilled syringe.
Adults with Crohn’s disease will receive their starter doses with Skyrizi through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. After completing the starter doses, patients will receive Skyrizi as an injection under the skin (subcutaneous injection) using the prefilled cartridge with on-body injector.
Before self-injecting with Skyrizi prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector, your healthcare provider should show you how to inject Skyrizi.
If you miss your dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do.
If you inject more Skyrizi than prescribed, call your healthcare provider right away.
Ask your doctor or pharmacist if you don't understand how to use an injection.
Skyrizi should be clear or light-yellow. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.
Your healthcare provider will show you where to inject Skyrizi. Do not inject into the same place two times in a row. Avoid injecting into skin that is hard, red, bruised, swollen, tender, or affected by psoriasis. Do not inject within 2 inches of your navel (belly button).
You may get infections more easily, even serious infections. You will need frequent medical tests.
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.
Store this medicine in the original carton in a refrigerator and use until expiration date. Protect from light and do not shake or freeze.
Take the medicine out of the refrigerator and let it reach room temperature for 30 to 90 minutes before using. Do not heat the medicine in a microwave or with hot water.
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.
Dosing information
Usual Adult Dose for Plaque Psoriasis:
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.
Use: For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Usual Adult Dose for Psoriatic Arthritis
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.
Use: For the treatment of active psoriatic arthritis in adults.
Usual Adult Dose for Crohn's disease:
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 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 prior to initiating treatment with this drug.
Use: For the treatment of moderately to severely active Crohn's disease in adults.
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 Skyrizi?
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).
Skyrizi side effects
Get emergency medical help if you have signs of an allergic reaction to Skyrizi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor right away if you have signs of infection such as:
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fever, chills, sweating, body aches;
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shortness of breath, cough, bloody mucus;
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mouth sores, red or swollen gums;
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stomach pain, diarrhea;
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increased urination, burning when you urinate;
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pale skin, easy bruising, unusual bleeding;
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a fungal skin infection - skin sores different from psoriasis, rash or redness, blisters, itching, burning, cracking or peeling, changes in skin color; or
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signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.
Further doses may be delayed until your infection clears up.
Skyrizi may cause serious side effects including liver problems in adults with Crohn’s disease.
Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment. Your healthcare provider may stop treatment if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:
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unexplained rash;
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nausea;
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vomiting;
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stomach (abdominal) pain;
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tiredness (fatigue);
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loss of appetite;
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yellowing of the skin and eyes (jaundice);
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dark urine.
Common Skyrizi side effects in adults treated for Crohn’s disease may include:
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cold symptoms such as stuffy nose, sneezing, sore throat;
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pain, redness, itching, bruising, swelling, warmth, bleeding, burning, or other skin irritation where the medicine was injected;
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fever;
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headache;
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stomach (abdominal) pain;
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back pain;
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joint pain;
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low red blood cells (anemia).
Common Skyrizi side effects in adults treated for plaque psoriasis and psoriatic arthritis may include:
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cold symptoms such as stuffy nose, sneezing, sore throat;
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headache;
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feeling tired;
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fungal skin infections;
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injection site reactions.
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 FDA at 1-800-FDA-1088.
What other drugs will affect Skyrizi?
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.
Popular FAQ
For both plaque psoriasis and psoriatic arthritis, you’ll receive your first two starter doses of Skyrizi four weeks apart, then you’ll have an injection every 12 weeks thereafter (4 maintenance doses per year). For Crohn's disease, you'll receive 3 starter doses given into a vein 4 weeks apart (Week 0, 4 and 8) at a healthcare facility, then a subcutaneous (under the skin) injection given at Week 12, followed by an injection using a prefilled cartridge with an on-body injector every 8 weeks thereafter (6 maintenance doses per year). Continue reading
Skyrizi (risankizumab-rzaa) is a medication used to treat adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis and moderately-to-severely active Crohn's disease. Skyrizi is not known to interact with alcohol and there is no warning in the drug’s Product Label against drinking alcohol while receiving Skyrizi. However, people receiving treatment with Skyrizi may benefit from avoid alcohol if it makes the symptoms of their condition worse. Continue reading
More FAQ
- What causes Plaque Psoriasis?
- How long does it take for Skyrizi to work?
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Skyrizi only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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