Stelara (ustekinumab)

Reviewed by: HU Medical Review Board | Last reviewed: August 2023

Stelara® (ustekinumab) is a type of biologic therapy used to treat adults with moderately to severely active Crohn's disease and adults with moderately to severely active ulcerative colitis (UC).1,2

Stelara is also approved as a treatment for moderate to severe plaque psoriasis and active psoriatic arthritis.1

How does Stelara work?

Stelara is a type of biologic medicine called a monoclonal antibody. Monoclonal antibodies are human-made proteins that work like the antibodies your body makes. Like your own antibodies, monoclonal antibodies stick to targets to help the immune system.1,2

In people with IBD, Stelara locks to chemical messengers in the body called IL-12 and IL-23. IL-12 and IL-23 play a key role in the inflammatory process of the immune system. In autoimmune diseases like IBD, the immune system mistakenly attacks itself and the cells that line the gastrointestinal tract. Stelara works by blocking IL-12 and IL-23, which in turn reduces inflammation and the symptoms of CD and UC.1,2

What are the possible side effects?

The most common side effects of Stelara in IBD treatment include:1

  • Congestion, sore throat, and runny nose
  • Headache
  • Stomach pain
  • Flu
  • Fever
  • Diarrhea
  • Sinus infection
  • Tiredness
  • Nausea

These are not all the possible side effects of Stelara. Talk to your doctor about what to expect when taking Stelara. Call your doctor if you have any changes that concern you when taking Stelara.

Other things to know

Stelara is given through an injection under the skin. The first dose of Stelara is given as an infusion in a healthcare facility by a doctor. If your doctor decides that you or a caregiver may inject your next doses at home, they will train you on the right way to prepare and inject Stelara.1

Stelara lowers the body’s immune response. People taking it can be more likely to get infections and have a harder time fighting them off if they do. Your doctor will monitor you closely for any signs of infection or other serious side effects while you are taking the drug.1

People who currently have an infection or infectious disease may not be able to start treatment with Stelara until the infection is gone. Before starting treatment with Stelara, tell your doctor if you:1

  • Think you have an infection or have symptoms of an infection, such as fever, cough, diarrhea or stomach pain, or burning when you urinate
  • Are being treated for an infection or have any open cuts
  • Get a lot of infections or have infections that keep coming back
  • Have tuberculosis (TB) or have been in close contact with someone with TB
  • Are allergic to latex, since the needle cover on each Stelara syringe contains latex
  • Are receiving or have received allergy shots

People taking Stelara cannot receive live vaccines during treatment. You will also be tested for tuberculosis before starting treatment.1

There is not enough data to know if Stelara is safe to take while pregnant or breastfeeding. Before starting treatment with Stelara, tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.1

Before beginning treatment for IBD, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Stelara.

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