guselkumab
Tremfya · ATC code L04AC16
- Key facts
- Active substance
- guselkumab
- Drug class
- Immunosuppressive drug
- ATC code
- L04AC16
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Tremfya 45 mg/0.45 mL solution for injection in pre-filled pen · Tremfya 100 mg solution for injection in pre-filled syringe · Tremfya 100 mg OnePress solution for injection in pre-filled pen / Tremfya 100 mg PushPen solution for injection in pre-filled pen · Tremfya 200 mg solution for injection in pre-filled syringe / Tremfya 200 mg solution for injection in pre-filled pen · Tremfya 200 mg concentrate for solution for infusion
- Marketing authorisation holder
- Janssen-Cilag International NV
- Information as of
- 2026-10-27
Key facts
Guselkumab (Tremfya) is an interleukin-23-directed monoclonal antibody for plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease.
What it is used for
- Moderate to severe plaque psoriasis in adults and in children and adolescents from 6 years who are candidates for systemic therapy
- Active psoriatic arthritis in adults, alone or with methotrexate, after inadequate response or intolerance to a DMARD
- Moderately to severely active ulcerative colitis and Crohn's disease in adults after failure of conventional or biologic therapy
Dosing
- Plaque psoriasis (adults and children from 6 years weighing 40 kg or more): 100 mg subcutaneously at weeks 0 and 4, then every 8 weeks
- Children from 6 years under 40 kg: weight-based dose up to a maximum of 45 mg with the 45 mg pen (table in full text)
- Psoriatic arthritis: 100 mg at weeks 0 and 4, then every 8 weeks; every 4 weeks may be considered at high risk of joint damage
- Ulcerative colitis and Crohn's disease: induction with 200 mg intravenously or 400 mg subcutaneously at weeks 0, 4 and 8; then subcutaneous maintenance (details in full text)
- Consider stopping if no response (after 16 or 24 weeks depending on indication)
Contraindications
- Serious hypersensitivity to the active substance or any excipient
- Clinically important active infections (e.g. active tuberculosis)
Important warnings
- May increase the risk of infection; interrupt treatment for serious infections until resolved
- Evaluate for tuberculosis before starting
- Serious hypersensitivity reactions including anaphylaxis possible
- Liver enzyme elevations, more frequent with every-4-week dosing
- Live vaccines should not be used concurrently
Side effects
- Very common: respiratory tract infections
- Common: headache, diarrhoea, rash, arthralgia, injection site reactions, transaminase increase
- Uncommon: herpes simplex, tinea infections, gastroenteritis, urticaria; rare: anaphylaxis
Interactions
- Interactions with CYP450 substrates unlikely; no dose adjustment needed
- Combination with immunosuppressants or phototherapy not evaluated in psoriasis
- Live vaccines should not be given concurrently
Pregnancy and breastfeeding
- Effective contraception during and for at least 12 weeks after treatment; preferable to avoid use during pregnancy
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)
- TremfyaJanssen-Cilag International NV · EMEA/H/C/004271
Source: European Medicines Agency (EMA), product information
Turkey
- TremfyaJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 6 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Tremfya
- Liechtenstein
- Tremfya
- Norway
- Tremfya
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. Tremfya – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/tremfya-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.