Generic name: risankizumab (RIS an KIZ ue mab)
Brand name: Skyrizi
Drug class: Interleukin inhibitors
Skyrizi (risankizumab) is an interleukin-23 antagonist. Interleukin-23 triggers an inflammatory response in the skin.
Skyrizi injection 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).
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 if you have symptoms such as fever, chills, cough, trouble breathing, diarrhea, burning when you urinate, weight loss, or skin sores on your body (different from psoriasis).
Before taking this medicine
Before you start treatment with Skyrizi, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.
Tell your doctor if you currently have signs of infection such as fever, chills, muscle pain, cough, trouble breathing, skin sores, stomach pain, diarrhea, weight loss, or painful urination.
Make sure you are current on all vaccines before you begin treatment with Skyrizi.
Tell your doctor if you are pregnant or breastfeeding.
Skyrizi is not approved for use by anyone younger than 18 years old.
How should I use Skyrizi?
Skyrizi is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Read and carefully follow any Instructions for Use provided with your medicine. You may need to use 2 injections to get your total dose. Ask your doctor or pharmacist if you don't understand all instructions.
Skyrizi should be clear or light-yellow. Do not use if the medicine looks cloudy, has changed colors, or has flakes or large particles in it. Call your pharmacist for new medicine.
Your care provider will show you where on your body to inject Skyrizi. Do not inject into skin with active psoriasis, or skin that is red, bruised, or tender. Do not inject within 2 inches of your navel (belly button).
Skyrizi affects your immune system. You may get infections more easily. Your doctor will need to examine you on a regular basis.
Store Skyrizi in the original container in a refrigerator. Protect from light and do not shake or freeze. Take the medicine out of the refrigerator and allow it to reach room temperature for 15 to 30 minutes before injecting your dose. Do not heat the medicine in a microwave or with hot water.
Each prefilled Skyrizi syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
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.
-Administer the injections at different anatomic locations (e.g., thigh, abdomen) and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Administration into the upper outer arm may only be performed by a healthcare professional or caregiver.
Use: For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
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?
Do not receive a "live" vaccine while using Skyrizi. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
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.
You may get infections more easily. 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.
If you develop an infection, you may need to postpone your next injection until the infection clears up.
Common Skyrizi side effects may include:
- headache;
- tiredness;
- cold symptoms such as stuffy nose, sneezing, sore throat;
- fungal skin infections; or
- pain, redness, itching, bruising, swelling, warmth, bleeding, burning, or other skin irritation where the medicine was injected.
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 your current medicines and any medicine you start or stop using.