Medications and Drugs
Brand Names: Stelara, Stelara PFS
Generic Name: ustekinumab (Pronunciation: YOO sti KIN ue mab)
What is ustekinumab (Stelara, Stelara PFS)?
Ustekinumab is an immunosuppressant that reduces the effects of a chemical 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 purposes not listed in this medication guide.
What are the possible side effects of ustekinumab (Stelara, Stelara PFS)?
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:
Less serious side effects may include:
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, Stelara PFS)?
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).
BCG vaccine should not be given for at least 1 year after you receive your last dose of ustekinumab.
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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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