golimumab
Simponi · ATC code L04AB06
- Key facts
- Active substance
- golimumab
- Drug class
- Immunosuppressive drug
- ATC code
- L04AB06
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Simponi 45 mg/0.45 mL solution for injection in pre-filled pen · Simponi 50 mg solution for injection in pre-filled syringe · Simponi 50 mg solution for injection in pre-filled pen · Simponi 100 mg solution for injection in pre-filled syringe · Simponi 100 mg solution for injection in pre-filled pen
- Marketing authorisation holder
- Janssen Cilag International NV
- Information as of
- 2026-10-28
Key facts
Golimumab is a monoclonal antibody against tumour necrosis factor alpha (TNF blocker) used to treat inflammatory rheumatic diseases and ulcerative colitis (Simponi, subcutaneous injection).
What it is used for
- Adults: rheumatoid arthritis (with methotrexate), psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and moderately to severely active ulcerative colitis after inadequate response to conventional therapy.
- Children 2 years and older: polyarticular juvenile idiopathic arthritis (with methotrexate) after inadequate response to methotrexate.
- Children 2 years and older weighing at least 15 kg: moderately to severely active ulcerative colitis after inadequate response to conventional therapy.
Dosing
- Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis: 50 mg once a month on the same date; above 100 kg without adequate response after 3 or 4 doses, increase to 100 mg may be considered (higher risk of certain serious adverse reactions).
- Adult ulcerative colitis below 80 kg: 200 mg, then 100 mg at week 2, then 50 mg from week 6 every 4 weeks (100 mg if response is inadequate); 80 kg or more: 200 mg, 100 mg at week 2, then 100 mg every 4 weeks.
- Polyarticular JIA: at least 40 kg, 50 mg once a month; below 40 kg, 30 mg/m² body surface area (maximum 40 mg) once a month using the 45 mg/0.45 mL pen.
- Paediatric ulcerative colitis: weight-based induction and maintenance doses (e.g. 15 kg to <40 kg: 100 mg at week 0, 50 mg at week 2, then 50 mg every four weeks); details: see the full text.
- Response usually within 12 to 14 weeks; reconsider continued therapy if there is no benefit.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Active tuberculosis or other severe infections such as sepsis, and opportunistic infections.
- Moderate or severe heart failure (NYHA class III/IV).
Important warnings
- Serious infections (sepsis, pneumonia, TB, invasive fungal infections), including fatalities; monitor before, during and for up to 5 months after treatment.
- Hepatitis B reactivation in chronic carriers.
- A possible risk of lymphoma, leukaemia and other malignancies cannot be excluded.
- Demyelinating disorders, heart failure, haematologic reactions and serious hypersensitivity reactions have been reported.
- No live vaccines during treatment.
Side effects
- Most common: upper respiratory tract infection (12.6% with golimumab vs 11.0% with control).
- Serious: serious infections, demyelinating disorders, HBV reactivation, congestive heart failure, lupus-like syndrome, haematologic reactions, anaphylaxis, vasculitis, lymphoma and leukaemia.
Interactions
- Combination with other biologics for the same conditions (e.g. anakinra, abatacept) is not recommended.
- Live vaccines and therapeutic infectious agents should not be given concurrently.
- Methotrexate raises trough levels, but no dose adjustment is needed.
Pregnancy and breastfeeding
- Women of childbearing potential must use contraception until at least 6 months after the last dose; use in pregnancy only if clearly needed. Infants exposed in utero should not receive live vaccines for 6 months.
- Do not breast-feed during and for at least 6 months after treatment.
Summary of the official product information, written with AI on 2026-10-29. 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
This product has no separate US patient information.
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)
- Gobivaz · biosimilarAdvanz Pharma Limited · EMEA/H/C/006560
- Gotenfia · biosimilarStada Arzneimittel AG · EMEA/H/C/006621
- SimponiJanssen Cilag International NV · EMEA/H/C/000992
Source: European Medicines Agency (EMA), product information
Turkey
- SimponiJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Gobivaz, Gotenfia, Simponi
- Liechtenstein
- Gobivaz, Gotenfia, Simponi
- Norway
- Gobivaz, Gotenfia, Simponi
EMA – Article 57 product data (EU/EEA), 2026-10-29
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. Simponi – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/simponi-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L04AB.
Editorial: Medelix editorial team · last updated 2026-10-28 · 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.