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Stelara (ustekinumab)

Ustekinumab is a type of medication called a biologic therapy, and it is sold in the United States under the brand name Stelara. Ustekinumab is a monoclonal antibody that specifically targets interleukin 12 (IL-12) and interleukin 23 (IL-23). These interleukins are specific proteins that are involved in the inflammatory response, which is overactive in people with inflammatory bowel disease (IBD) like Crohn’s disease or ulcerative colitis.1

Overview of biologic therapies

Biologic therapies, or “biologics,” are drugs that have been genetically engineered to act on specific cells or proteins that are involved in the immune system’s inflammatory process. Unlike other immune therapies that have an overall, systemic suppressing effect on the immune system, biologics create far less interference with other biological functions.2

What is ustekinumab?

Ustekinumab is an injection medication that is used to treat moderately to severely active Crohn’s disease (CD) who have already tried treatment with immunomodulators, corticosteroids, or tumor necrosis factor (TNF) inhibitors and the previous treatments didn’t work for them or caused a bad reaction. Ustekinumab is also approved as a treatment for moderate to severe plaque psoriasis and active psoriatic arthritis.3,4

Ustekinumab should only be used in patients aged 18 years or older when treating Crohn’s.4

How does ustekinumab work?

As a monoclonal antibody, ustekinumab has been created in a laboratory to specifically target and block the action of IL-12 and IL-23. IL-12 and IL-23 are chemical messengers that are critical to the inflammatory process of the immune system. In autoimmune diseases like IBD, the inflammatory response is abnormally activated, and the chronic inflammation causes damage to the intestinal tract. Ustekinumab blocks IL-12 and IL-23, reducing the inflammatory response and reducing the symptoms of CD.1,4

What are the possible side effects of ustekinumab?

The most common side effects experienced by people with CD who took ustekinumab include vomiting, upper respiratory tract infections, vaginal yeast infections, redness and irritation at the injection site, and itching.4

Ustekinumab may cause some side effects that are serious and require immediate medical care, such as seizures, confusion, vision changes, feeling faint, difficulty breathing, tightness in the chest or throat, rash, or swelling of the face, tongue or throat.4

Ustekinumab may lower the body’s ability to fight infections and may increase the risk of infections. Some people experience serious infections while taking ustekinumab and may require hospitalization. Ustekinumab may increase the risk of developing certain types of cancer. This is not a complete list of side effects. Talk to your doctor about any other side effects that may arise.4

Things to know about Stelara

  • Before taking ustekinumab, patients should tell their doctor if they have any signs of an infection, such as fever, sweats, chills, muscle aches, cough, shortness of breath, weight loss, diarrhea or stomach pain, blood in phlegm, sores on the body, burning during urination, or feeling very tired.
  • Patients should be tested for tuberculosis (TB) before beginning treatment with ustekinumab.
  • Any vaccines should be taken before taking ustekinumab as directed by your physician, and patients taking ustekinumab should talk to their doctor before receiving any vaccinations.
  • The needle cover on the prefilled syringe of ustekinumab contains latex. People who are allergic to latex should tell their doctor.
  • Women who are pregnant, planning to become pregnant, or who are breastfeeding should talk to their doctor before taking ustekinumab.4


For people with CD, ustekinumab is initially given as an intravenous (IV) infusion by a medical professional. The dosage is based on the patient’s weight. After the initial IV dose, subsequent doses are given subcutaneously (under the skin) as a 90 mg dose every 8 weeks for maintenance of CD.4

For additional information on ustekinumab, read the full prescribing information.

Written by: Anna Nicholson and Emily Downward | Last Reviewed: September 2019.
  1. Simon EG, Ghosh S, Iacucci M, Moran GW. Ustekinumab for the treatment of Crohn's disease: can it find its niche? Therapeutic Advances in Gastroenterology. 2016;9(1):26-36. doi:10.1177/1756283X15618130.
  2. Biologic Therapies. Crohn's & Colitis Foundation of America. Available at: Accessed 1/22/18.
  3. Recently Approved Treatments fact sheet. Crohn's and Colitis Foundation of America. Available at Accessed 1/22/18.
  4. Stelara prescribing information, Jannsen Biotech, Inc. Available at Accessed 1/22/18.