Stelara (ustekinumab). Stelara (ustekinumab) is a treatment for several conditions. It works by blocking certain proteins in the body. This helps reduce inflammation.
It treats plaque psoriasis in adults and kids over 6, who haven’t seen results with other treatments.
It helps with psoriatic arthritis in adults, with or without methotrexate.
It’s for Crohn’s disease in adults who haven’t responded to other treatments.
It’s also for ulcerative colitis in adults who haven’t seen results with other treatments.
Stelara comes in a few forms. You can get it as a syringe or vial for injection under the skin. There’s also a vial for injecting it into a vein.
How does Stelara (ustekinumab) work?
Ustekinumab is a protein that targets certain proteins in the body. These proteins, IL-12 and IL-23, are involved in inflammation. They play a big role in diseases like psoriasis and Crohn’s disease.
By blocking IL-12 and IL-23, ustekinumab slows down inflammation. This helps manage symptoms.
Where has Stelara (ustekinumab) been approved?
Stelara has been approved in many places. It’s been okay’d by:
The European Medicines Agency (EMA), Europe:
On January 15, 2009 for adults with plaque psoriasis.
On September 23, 2013 for adults active psoriatic arthritis.
On June 29, 2015, for adults with moderately to severely active Crohn’s disease.
On November 11, 2016, for adolescents with moderate to severe plaque psoriasis.
On September 4, 2019, for adults with moderately to severely active ulcerative colitis.
On January 15, 2020 for pediatric patients with moderate to severe plaque psoriasis.
The Food and Drug Administration (FDA), USA:
On September 25, 2009 for adults with plaque psoriasis.
On September 23, 2013 for adults active psoriatic arthritis.
On September 26, 2016 for adults with moderately to severely active Crohn’s disease.
On October 13, 2017 for adolescents with moderate to severe plaque psoriasis.
On October 21, 2019 for adults with moderately to severely active ulcerative colitis.
On July 30, 2020 for pediatric patients with moderate to severe plaque psoriasis.
Stelara has also been given special status by the FDA. This includes for type 1 diabetes, pediatric Crohn’s disease, ulcerative colitis, and systemic lupus erythematosus.
This medicine might be approved in other places too. If you have questions, our support team can help.
How is Stelara (ustekinumab) taken?
Plaque Psoriasis
The standard dosage is:
For patients weighing 100 kg or less: 45 mg given by under the skin (subcutanous) injection initially and 4 weeks later, followed by 45 mg every 12 weeks.
For patients weighing more than 100 kg, the recommended dose is 90 mg subcutaneously initially and 4 weeks later, followed by 90 mg every 12 weeks.
Psoriatic Arthritis
The standard dosage is:
45 mg given by under the skin (subcutaneous) injection initially and 4 weeks later, followed by 45 mg every 12 weeks.
For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg: 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.
Crohn’s Disease
A starting dose is given via intravenous infusion using a body weight-based regimen listed in the prescribing information, followed by a maintenance dosing schedule of a 90 mg subcutaneous maintenance injection every 8 weeks.
Ulcerative Colitis
A single body weight-based dose is given via intravenous infusion, followed by a maintenance dosing schedule of a 90 mg subcutaneous maintenance injection every 8 weeks.
Complete information about Stelara dosage and administration can be found in the official prescribing information listed in our references section.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Stelara (ustekinumab)?
Common adverse reactions
The most common adverse reactions (≥3% of patients) listed in the prescribing information include:
Headache
Nasopharyngitis (inflammation of the nose and throat)
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
Increased risk of infections (bacterial, fungal, and viral)
Decreased activity of your immune system and increased risk for certain types of cancer
Use in a specific population
It is not known whether Stelara (ustekinumab) can cause fetal harm when given to a pregnant woman; it is advised to avoid pregnancies and breastfeeding.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
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