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Brand Names: Stelara

Generic Name: ustekinumab (Pronunciation: YOO sti KIN ue mab)

• What is ustekinumab (Stelara)?
• What are the possible side effects of ustekinumab (Stelara)?
• What is the most important information I should know about ustekinumab (Stelara)?
• What should I discuss with my health care provider before using ustekinumab (Stelara)?
• How should I use ustekinumab (Stelara)?
• What happens if I miss a dose (Stelara)?
• What happens if I overdose (Stelara)?
• What should I avoid while using ustekinumab (Stelara)?
• What other drugs will affect ustekinumab (Stelara)?
• Where can I get more information?

What is ustekinumab (Stelara)?

Ustekinumab is an immunosuppressant that reduces the effects of a substance in the body that can cause inflammation.

Ustekinumab is used to treat plaque psoriasis (raised, silvery flaking of the skin) in adults.

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

What are the possible side effects of ustekinumab (Stelara)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness;
• mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
• swelling, pain, tenderness, or redness anywhere on your body;
• pain or burning when you urinate, blood in your urine;
• stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation);
• cough with yellow or green mucus;
• stabbing chest pain, feeling short of breath; or
• severe headache, confusion, vision problems, and/or seizure (convulsions).

Less serious side effects may include:

• cold symptoms (runny or stuffy nose, sore throat);
• headache, tired feeling;
• mild diarrhea; or
• mild skin rash or itching.

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 is the most important information I should know about ustekinumab (Stelara)?

You should not use this medication if you are allergic to ustekinumab or if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past year (12 months).

Before using ustekinumab, tell your doctor if you have an active infection, a history of tuberculosis or recurrent infections, high blood pressure, a weak immune system, or if you are receiving phototherapy (light therapy).

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Make sure you are current on all vaccines before you start treatment with ustekinumab.

Ustekinumab can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses.

Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, swelling or redness, pain or burning when you urinate, blood in your urine, severe stomach pain, changes in your bowel habits, cough with yellow or green mucus, stabbing chest pain, or severe headache with confusion, vision problems, or seizure.

Treatment with ustekinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.

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