filgotinib
Jyseleca · ATC code L04AF04
- Key facts
- Active substance
- filgotinib
- Drug class
- Immunosuppressive drug
- ATC code
- L04AF04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Jyseleca 100 mg film-coated tablets / Jyseleca 200 mg film-coated tablets
- Marketing authorisation holder
- Alfasigma S.p.A.
- Information as of
- 2026-10-28
Key facts
Filgotinib is a Janus kinase (JAK) inhibitor used to treat moderate to severe rheumatoid arthritis and ulcerative colitis in adults (Jyseleca, film-coated tablets).
What it is used for
- Moderate to severe active rheumatoid arthritis in adults with inadequate response to or intolerance of one or more DMARDs; as monotherapy or with methotrexate.
- Moderately to severely active ulcerative colitis in adults with inadequate response, loss of response or intolerance to conventional therapy or a biologic agent.
Dosing
- Rheumatoid arthritis: 200 mg once daily; in adults at increased risk of VTE, MACE and malignancy and from 65 years, 100 mg once daily, escalated to 200 mg if disease control is insufficient.
- Ulcerative colitis: induction 200 mg once daily; if benefit is inadequate after 10 weeks, a further 12 weeks may help; discontinue if no benefit after 22 weeks. Maintenance 200 mg once daily, or 100 mg at higher risk or from 65 years; not recommended from 75 years.
- Moderate or severe renal impairment (CrCl 15 to < 60 mL/min): 100 mg once daily; end-stage renal disease and severe hepatic impairment (Child-Pugh C): not recommended.
- Do not start, or interrupt, if ANC < 1 × 10⁹ cells/L, ALC < 0.5 × 10⁹ cells/L or Hb < 8 g/dL, or during serious infection. Use the lowest effective dose long term.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Active tuberculosis or active serious infections.
- Pregnancy.
Important warnings
- In patients 65 years and older, with atherosclerotic cardiovascular disease or other cardiovascular risk factors (e.g. long-time smokers), or with malignancy risk factors, use only if no suitable alternatives are available.
- Serious and opportunistic infections (most frequently pneumonia; also TB, oesophageal candidiasis, cryptococcosis).
- Venous thromboembolism (DVT, PE) and major adverse cardiovascular events (MACE) have been observed with JAK inhibitors.
- Live vaccines are not recommended during or immediately before treatment; update immunisations beforehand.
- Check lipid parameters 12 weeks after starting.
Side effects
- Rheumatoid arthritis, most frequent: nausea (3.5%), upper respiratory tract infection (3.3%), urinary tract infection (1.7%), dizziness (1.2%) and lymphopenia (1.0%).
- Uncommon: herpes zoster, pneumonia, sepsis, neutropenia, hypercholesterolaemia.
- In ulcerative colitis the safety profile was generally consistent.
Interactions
- Combination with other potent immunosuppressants (e.g. ciclosporin, tacrolimus, biologics, other JAK inhibitors) is not recommended.
- Filgotinib is mainly metabolised by CES2, which can be inhibited by medicines such as fenofibrate, carvedilol, diltiazem or simvastatin; clinical relevance unknown.
Pregnancy and breastfeeding
- Contraindicated during pregnancy; women of childbearing potential must use effective contraception during and for at least 1 week after treatment.
- Should not be used during breast-feeding.
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)
- JyselecaAlfasigma S.p.A. · EMEA/H/C/005113
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Jyseleca
- Liechtenstein
- Jyseleca
- Norway
- Jyseleca
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?
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Sources
- European Medicines Agency. Jyseleca – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/jyseleca-epar-product-information_en.pdf
- Wikidata (CC0): ATC L04AF.
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.