Risankizumab-rzaa (ris-an-KIZ-ue-mab - rzaa)

Treats plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Brand Name(s):

Skyrizi, Skyrizi 180MG/1.2ML, Skyrizi 360MG/2.4ML, Skyrizi 600MG/10ML

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in a vein or as a shot under your skin, usually in the stomach, thighs, or upper arms.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes in 4 forms: a prefilled pen, a prefilled syringe, a prefilled cartridge with on-body injector, and a vial. Your doctor will tell you which dosage form you should use. The vial is given by a nurse or other trained health professional.
• Allow the medicine to warm to room temperature for 30 to 90 minutes for the prefilled pen, 15 to 30 minutes for the prefilled syringe, and 45 to 90 minutes for the prefilled cartridge with on-body injector, without removing the medicine from the carton, before you use it. Do not warm the medicine in any other way.
• Check the liquid in the prefilled pen, syringe, or cartridge. It should be clear and colorless to yellow or slightly yellow and may contain small particles. Do not use the medicine if it is cloudy, discolored, or has flakes or large particles in it. Do not shake.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into areas where the skin is tender, bruised, red, hard, thick, scaly, or in areas with scars, stretch marks, or is affected by psoriasis.
• Use a new needle and syringe each time you inject your medicine. Use each prefilled pen, syringe, or cartridge only one time. Do not save an open medicine.
• Do not use the pen, syringe, or cartridge if it has been dropped or damaged. Do not remove the needle cover until you are ready to use it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in its original carton until you are ready to use it. Protect it from light. Do not use the medicine if it has been frozen, even if it has been thawed.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live vaccines while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, any type of infection, active tuberculosis (TB), or a history of TB.
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has been exposed to TB.
• This medicine may cause the following problems:
  • Increased risk for infections, which may be life-threatening
  • Liver problems
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, bloody or cloudy urine, lower back or side pain
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, stuffy or runny nose, body aches
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Back or joint pain
• Headache
• Itching of the genitals or other skin areas
• Pain, redness, swelling, or itching where the needle is placed
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088