Stelara
Stelara ingredients
| Active ingredient | Strength |
|---|---|
| Ustekinumab | 45 mg/.5mL, 130 mg/26mL, 90 mg/mL |
What Stelara is used for
The FDA lists the approved uses on the official label (below). In the EU, ustekinumab is approved as Stelara for:
Adult Crohn’s Disease Stelara is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn's Disease Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Adult ulcerative colitis Stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Paediatric ulcerative colitis Stelara is indicated for the treatment of moderately to severely active…
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Stelara
- Generic name
- Ustekinumab
- Made by
- Janssen Biotech, Inc.
- Forms
- Injection, Solution, Solution
- Given
- Intravenous, Subcutaneous
- Drug class
- Interleukin-12 Antagonist, Interleukin-23 Antagonist
- FDA approval
- Biologic licence (BLA) BLA125261
- On the US market since
- 2009
Official information
- Stelara prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Ustekinumab)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Stelara?
Stelara (Ustekinumab) is a specialist medicine made by Janssen Biotech, Inc., approved by the US FDA.
What are the ingredients of Stelara?
Stelara contains Ustekinumab (45 mg/.5mL, 130 mg/26mL, 90 mg/mL).
Is Stelara approved in Europe?
The same active substance is approved in the EU as Stelara.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA