ustekinumab
Stelara · ATC code L04AC05
- Key facts
- Active substance
- ustekinumab
- Drug class
- Immunosuppressive drug
- ATC code
- L04AC05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- STELARA 130 mg concentrate for solution for infusion · STELARA 45 mg solution for injection / STELARA 45 mg solution for injection in pre-filled syringe / STELARA 90 mg solution for injection in pre-filled syringe · STELARA 45 mg solution for injection in pre-filled pen / STELARA 90 mg solution for injection in pre-filled pen
- Marketing authorisation holder
- Janssen-Cilag International NV
- Information as of
- 2026-10-27
Key facts
Ustekinumab (STELARA) is a monoclonal antibody against interleukin-12 and -23. It is used for plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
What it is used for
- Moderate to severe plaque psoriasis in adults after failure of other systemic therapies; in children from 6 years
- Active psoriatic arthritis in adults, alone or with MTX
- Moderately to severely active Crohn's disease in adults and children from 2 years
- Moderately to severely active ulcerative colitis in adults and children from 2 years
Dosing
- Psoriasis and psoriatic arthritis (subcutaneous): 45 mg, again 4 weeks later, then every 12 weeks; 90 mg for body weight > 100 kg
- Crohn's disease and ulcerative colitis: single weight-based intravenous induction (260 mg, 390 mg or 520 mg; 130 mg concentrate)
- Then 90 mg subcutaneously at week 8, then every 12 weeks, or every 8 weeks if response is lost
- Paediatric weight- or BSA-based dosing: see the full product information
- No dose adjustment from 65 years; no recommendations in renal or hepatic impairment
Contraindications
- Hypersensitivity to the active substance or any of the excipients
- Clinically important, active infection (e.g. active tuberculosis)
Important warnings
- Increased risk of serious and opportunistic infections and reactivation of latent infections; evaluate for tuberculosis before starting
- Serious hypersensitivity reactions including anaphylaxis
- Caution with chronic or recurrent infection
- Record tradename and batch number
Side effects
- Most common: nasopharyngitis (6.9%) and headache (7.0%)
- Most serious: serious hypersensitivity reactions including anaphylaxis
- Serious bacterial, fungal and viral infections
Interactions
- No live vaccines concurrently with treatment
- Live vaccines not recommended for infants exposed in utero for twelve months after birth
Pregnancy and breastfeeding
- As a precaution, preferably avoid in pregnancy; contraception during and for at least 15 weeks after treatment
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Fymskina · biosimilarFormycon AG · EMEA/H/C/005805
- Imuldosa · biosimilarAccord Healthcare S.L.U. · EMEA/H/C/006221
- Otulfi · biosimilarFresenius Kabi Deutschland GmbH · EMEA/H/C/006544
- Pyzchiva · biosimilarSamsung Bioepis NL B.V. · EMEA/H/C/006183
- StelaraJanssen-Cilag International NV · EMEA/H/C/000958
- Steqeyma · biosimilarCelltrion Healthcare Hungary Kft. · EMEA/H/C/005918
- Usgena · biosimilarStada Arzneimittel AG · EMEA/H/C/006667
- Usrenty · biosimilarBiosimilar Collaborations Ireland Limited · EMEA/H/C/006794
- Usymro · biosimilarGedeon Richter Plc. · EMEA/H/C/006467
- Uzpruvo · biosimilarStada Arzneimittel AG · EMEA/H/C/006101
- Wezenla · biosimilarAmgen Technology (Ireland) UC · EMEA/H/C/006132
- Yesintek · biosimilarBiosimilar Collaborations Ireland Limited · EMEA/H/C/006444
Source: European Medicines Agency (EMA), product information
Turkey
- StelaraJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 4 register entries
- UsteviaABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Fymskina, Imuldosa, Otulf, Otulfi, Stelara, Steqeyma, Usgena, Usrenty, Usymro, Uzpruvo, Wezenla, Yesintek
- Liechtenstein
- Fymskina, Imuldosa, Otulfi, Stelara, Steqeyma, Usgena, Usrenty, Usymro, Uzpruvo, Yesintek
- Norway
- Fymskina, Imuldosa, Otulfi, Stelara, Steqeyma, Usgena, Usrenty, Usymro, Uzpruvo, Wezenla, Yesintek
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Stelara – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L04AC.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.