Skyrizi
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
What is Skyrizi?
Skyrizi (risankizumab) is a prescription medication used to treat types of plaque psoriasis, psoriatic arthritis, ulcerative colitis, or Crohn’s disease, which are all autoimmune disorders. Skyrizi works by targeting a specific protein in the immune system called interleukin-23 (IL-23), which is responsible for causing inflammation in these conditions. Skyrizi helps reduce inflammation, which improves the symptoms of these conditions, by attaching to and blocking IL-23.
Skyrizi can be given by self-injection under the skin using an autoinjector (pen) or prefilled pen to treat plaque psoriasis or psoriatic arthritis. For Crohn’s disease and ulcerative colitis initial doses are given as an intravenous infusion then maintenance injections can be given using the prefilled cartridge with the on-body injector.
Skyrizi injection is given every 8 weeks to 12 weeks as a maintenance dose, after initial doses.
Who can use Skyrizi?
Skyrizi 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.
How does Skyrizi work?
Skyrizi 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, improving 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.
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.
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.
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 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 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.
Skyrizi side effects
Common Skyrizi side effects
Common Skyrizi side effects for plaque psoriasis include:
- Cold symptoms such as stuffy nose, sneezing, sore throat (13%)
- Headache (3.5%)
- Feeling tired, fatigue (2.5%)
- Fungal skin infections (1.1%)
- Injection site reactions (1.5%)
These side effects occurred in 1% or more of Skyrizi patients in 16 weeks of the plaque psoriasis clinical trial.
Common Skyrizi side effects for psoriatic arthritis were similar to plaque psoriasis clinical trials with the addition of:
- Hepatic events (5.4%)
- Hypersensitivity reactions including rash (0.7%), allergic rhinitis (0.3%), facial swelling (0.1%) and one patient had anaphylaxis in a Phase 2 clinical trial.
Common Skyrizi side effects for Crohn’s disease include:
- Joint pain (8.4%)
- Stomach (abdominal) pain (5.8%)
- Injection site reactions pain, redness, itching, bruising, swelling, warmth, bleeding, burning, or other skin irritation where the medicine was injected (4.5%)
- Low iron levels, anemia (4.5%)
- Fever (2.6%)
- Back pain (1.9%)
- Joint disease, arthropathy (0.6%)
- Urinary tract infection (0.6%)
- Lipid elevations
These side effects occurred in patients with Crohn’s Disease Treated with Skyrizi 180mg in a Placebo-Controlled 52-Week Maintenance Study (CD-3). Doses were from week 12 and every 8 weeks for 52 weeks.
Common Skyrizi side effects for ulcerative colitis include:
- Joint pain (5.3%)
- Fever (4.7%)
- Injection site reactions (2.9%)
- Rash (4.1%).
These side effects occurred in patients with ulcerative colitis treated with Skyrizi 180mg in a Placebo-Controlled 52-Week Maintenance Study (UC-2). Doses were from week 12 and every 8 weeks for 52 weeks.
Serious Skyrizi side effects
Get emergency medical help if you have signs of an allergic reaction to Skyrizi: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Infection side effects
Call your doctor right away if you have signs of infection such as
- fever, chills, sweating, body aches;
- shortness of breath, cough, bloody mucus;
- mouth sores, red or swollen gums;
- stomach pain, diarrhea;
- increased urination, burning when you urinate;
- pale skin, easy bruising, unusual bleeding;
- a fungal skin infection - skin sores different from psoriasis, rash or redness, blisters, itching, burning, cracking or peeling, changes in skin color; or
- 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.
Liver side effects
Skyrizi may cause serious side effects, including liver problems (hepatotoxicity) in adults with ulcerative colitis or 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:
- unexplained rash;
- nausea;
- vomiting;
- stomach (abdominal) pain;
- tiredness (fatigue);
- loss of appetite;
- yellowing of the skin and eyes (jaundice);
- dark urine.
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.
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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.
Skyrizi (risankizumab-rzaa) - AbbVie Inc.
Formulation type | Strength |
---|---|
Autoinjector | 150 mg/mL |
Pre-Filled Syringe | 150 mg/mL |
Pre-Filled Syringe | 75 mg/0.83 mL Discontinued |
Pre-Filled Syringe | 90 mg/mL |
Single-Dose Cartridge | 180 mg/1.2 mL (150 mg/mL) |
Single-Dose Cartridge | 360 mg/2.4 mL (150 mg/mL) |
Single-Dose Vial | 600 mg/10 mL (60 mg/mL) |
Popular FAQ
What are monoclonal antibodies?
Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading
What's the dosing schedule for Skyrizi?
After your initial starter doses, you'll receive Skyrizi as subcutaneous (under the skin) maintenance dose every 12 weeks (4 times per year) to treat either plaque psoriasis or psoriatic arthritis, or every 8 weeks (6 times per year) to treat either Crohn's disease or ulcerative colitis. You can self-administer these injections at home after proper training from your healthcare provider. Continue reading
Does Skyrizi cause cancer?
Skyrizi has no warnings or precautions for malignancy (cancer, tumors) in its product label and cancer is not listed as a serious or common side effect. Continue reading
Can you drink alcohol while taking Skyrizi?
Skyrizi (risankizumab-rzaa) is a medication used to treat adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis and moderately-to-severely active ulcerative colitis or 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
Skyrizi vs Humira for plaque psoriasis - How do they compare?
In a head-to-head clinical study between Skyrizi and Humira, researchers found that Skyrizi was better than Humira at clearing moderate-to-severe plaque psoriasis in adults. At 16 weeks, 72% of patients given Skyrizi achieved 90% clearer skin compared to 47% of patients given Humira, a statistically significant outcome. Continue reading
Who makes Skyrizi and where is it made?
Skyrizi is made by AbbVie Inc., a U.S. pharmaceutical company located in North Chicago, Illinois. They have multiple manufacturing plants, including ones in North Chicago, IL, Lake County, IL, Worcester, MA and Wyandotte, MI, as well as globally. You can contact AbbVie at 1-800-222-6885 or online at Abbvie.com. Continue reading
Is Skyrizi approved for treating psoriatic arthritis?
Yes, Skyrizi was approved in January 2022 to treat active psoriatic arthritis in adults. Skyrizi is also approved in adults to treat moderate-to-severe plaque psoriasis in people who are candidates for systemic (body-wide) therapy or skin phototherapy (ultraviolet light therapy), moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. Continue reading
Does Skyrizi cause hair loss?
No, Skyrizi (risankizumab) did not cause hair loss during clinical trials. It is not included as a side effect in the Skyrizi product information. Continue reading
Skyrizi vs Ilumya. What’s the difference?
There are a number of differences between Skyrizi and Ilumya:
- Ilumya was FDA approved in 2018 and Skyrizi was FDA approved in 2019.
- Ilyumya is a brand name for tildrakizumab and Skyrizi is a brand name for risankizumab
- The dose of Skyrizi is 150mg, but because each injection only contains 75mg, two injections must be given per dose. The dose of Ilumya is 100mg, and each injection contains 100mg therefore only one injection needs to be given each time
- Ilumya needs to be administered by a healthcare professional; however, patients prescribed Skyrizi can be taught how to self-administer it at home
- Skyrizi is also approved to treat adults with active psoriatic arthritis (PsA), Crohn's disease, and ulcerative colitis.
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