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.

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.

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.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. You may need to use 2 injections to get your total dose.

Risankizumab should be clear or light-yellow. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Your healthcare provider will show you where to inject risankizumab. Do not inject into the same place two times in a row. Avoid injecting into skin that is hard, red, bruised, swollen, tender, or affected by psoriasis. Do not inject within 2 inches of your navel (belly button).

You may get infections more easily, even serious infections. You will need frequent medical tests.

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.

Store risankizumab in the original carton in a refrigerator and use until expiration date. Protect from light and do not shake or freeze.

Take the medicine out of the refrigerator and let it reach room temperature for 30 to 90 minutes before using. Do not heat the medicine in a microwave or with hot water.

Throw away a prefilled syringe or injection pen after one use, even if there is still medicine left inside.

Throw away any risankizumab that has been frozen, dropped, or damaged.

Usual Adult Dose for Plaque Psoriasis:

150 mg (two 75 mg injections) subcutaneously at Week 0, Week 4, and every 12 weeks thereafter

Comments:
-Evaluate patients for tuberculosis (TB) infection prior to initiating this drug.

Use: For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

Tell your doctor if you have an active or chronic infection.

Tell your doctor if you've had or 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.

Tell your doctor if you recently received a vaccine or are scheduled for a booster dose.

Make sure you are current on all vaccines before you start using risankizumab.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risankizumab on the baby.

Not approved for use by anyone younger than 18 years old.

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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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.

Common side effects of risankizumab 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.

Other drugs may affect risankizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.