You should not use Stelara if you have received a BCG (Bacillus Calmette and Guérin) vaccine within 1 year prior to, during, or 1 year following treatment.
Before you start treatment with Stelara, your doctor may perform tests to make sure you do not have tuberculosis.
Serious infections may occur during treatment with Stelara. Call your doctor right away if you have signs of infection such as: fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.
Ustekinumab may also cause a rare but serious condition affecting the brain. Tell your doctor right away if you have a headache, confusion, vision problems, or a seizure.
Before taking this medicine
You should not use Stelara if you are allergic to ustekinumab, or if you have:
active tuberculosis; or
if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.
Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
To make sure Stelara is safe for you, tell your doctor if you have:
signs of infection (fever, chills, cough, muscle aches, painful skin sores, diarrhea, pain when you urinate, feeling very tired);
chronic infections;
new or changing skin lesions;
a latex allergy;
phototherapy (light therapy);
allergy shots; or
if you recently received or are scheduled to receive any vaccine.
Some people using Stelara have developed skin cancer (non-melanoma). However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ustekinumab on the baby.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
