Skyrizi (risankizumab) is a medication used to treat adults with certain types of plaque psoriasis, psoriatic arthritis, and 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 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, and for 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 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.

Skyrizi 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 risankizumab-rzaa or any of the ingredients in this medicine.  For a full list of ingredients click on this link Ingredients

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. 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 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 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 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 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.

Usual Adult 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, 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.

Skyrizi is available as: 

Subcutaneous Injection

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: 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.

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.

To make sure Skyrizi 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 Skyrizi tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if this medicine passes into your breast milk. 

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).

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.

Infections

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 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:

• unexplained rash;
• nausea;
• vomiting;
• stomach (abdominal) pain;
• tiredness (fatigue);
• loss of appetite;
• yellowing of the skin and eyes (jaundice);
• dark urine.

Common Skyrizi side effects in adults treated for Crohn’s disease.

• cold symptoms such as stuffy nose, sneezing, sore throat;
• pain, redness, itching, bruising, swelling, warmth, bleeding, burning, or other skin irritation where the medicine was injected;
• fever;
• headache;
• stomach (abdominal) pain;
• back pain;
• joint pain;
• low red blood cells (anemia).

Common Skyrizi side effects in adults treated for plaque psoriasis and psoriatic arthritis.

• cold symptoms such as stuffy nose, sneezing, sore throat;
• headache;
• feeling tired;
• fungal skin infections;
• 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.

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.