risankizumab

What is the most important information I should know about risankizumab?

What is risankizumab?

Risankizumab is used to treat moderate to severe plaque psoriasis in adults.

Risankizumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using risankizumab?

Before you start treatment with risankizumab, 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 risankizumab.

Tell your doctor if you are pregnant or breastfeeding.

How should I use risankizumab?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Risankizumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

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.

Risankizumab 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.

Risankizumab affects your immune system. You may get infections more easily. Your doctor will need to examine you on a regular basis.

Each prefilled 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.

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?

What should I avoid while using risankizumab?

Do not receive a "live" vaccine while using risankizumab. 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.

What are the possible side effects of risankizumab?

• 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 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 risankizumab?

Other drugs may affect 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.

Where can I get more information?

Your pharmacist can provide more information about risankizumab.