Tofacitinib
Xeljanz · ATC code L04AF01
Also known as: Tofasitinib · Brand names: Xeljanz, Tofacitinib Devatis, Tofacitinib Stada, Jandark, Janty, Phorlan, Tofanzi, Tofenol, Tofik, Tojantu, Tositin, Xliten
- Key facts
- Active substance
- Tofacitinib
- Drug class
- Immunosuppressive drug
- ATC code
- L04AF01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- XELJANZ 5 mg film-coated tablets / XELJANZ 10 mg film-coated tablets · XELJANZ 11 mg prolonged-release tablets · XELJANZ 1 mg/mL oral solution
- Marketing authorisation holder
- Pfizer Europe MA EEIG
- Information as of
- 2026-10-27
Key facts
Tofacitinib is a Janus kinase (JAK) inhibitor. It is used for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and juvenile idiopathic arthritis.
What it is used for
- Moderate to severe active rheumatoid arthritis in adults after inadequate response to DMARDs, with methotrexate or as monotherapy
- Active psoriatic arthritis in adults, in combination with methotrexate
- Active ankylosing spondylitis in adults
- Moderately to severely active ulcerative colitis in adults
- Polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis from 2 years
Dosing
- Rheumatoid and psoriatic arthritis: 5 mg film-coated tablet twice daily, not to be exceeded; alternatively 11 mg prolonged-release tablet once daily
- Ankylosing spondylitis: 5 mg twice daily
- Ulcerative colitis: induction 10 mg twice daily for 8 weeks (may be extended 8 more weeks), maintenance 5 mg twice daily
- UC maintenance at 10 mg twice daily only without VTE, MACE and malignancy risk factors and for the shortest duration possible
- Potent CYP3A4 inhibitors: reduce 5 mg twice daily to 5 mg once daily
- Children (JIA): oral solution or tablets by weight per the full text
Contraindications
- Hypersensitivity to the active substance or any excipient
- Active tuberculosis, serious infections such as sepsis, or opportunistic infections
- Severe hepatic impairment
- Pregnancy and lactation
Important warnings
- Use only if no suitable alternatives exist in patients 65 and older, with atherosclerotic cardiovascular disease or cardiovascular risk factors (e.g. smoking), or with malignancy risk factors
- Increased risk of serious infections, myocardial infarction, malignancies and all-cause mortality in patients 65 and older
- Venous thromboembolism including pulmonary embolism, some fatal
- Avoid combination with biologics and potent immunosuppressants (e.g. azathioprine, ciclosporin, tacrolimus)
- Herpes zoster, interstitial lung disease, gastrointestinal perforation
Side effects
- Most common serious reactions: serious infections (e.g. pneumonia, herpes zoster, urinary tract infection)
- Most common in the first 3 months: headache, upper respiratory tract infections, diarrhoea, nausea, hypertension
- Opportunistic infections including tuberculosis
Interactions
- Potent CYP3A4 inhibitors (e.g. ketoconazole) or combined CYP3A4/CYP2C19 inhibition (e.g. fluconazole) increase exposure
- Potent CYP inducers (e.g. rifampicin) decrease exposure
- No effect on oral contraceptives
Pregnancy and breastfeeding
- Contraindicated in pregnancy; teratogenic in animals; contraception during and for at least 4 weeks after the last dose
- Tofacitinib is excreted in human milk; lactation is a contraindication
Summary of the official product information, written with AI 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)
- XeljanzPfizer Europe MA EEIG · EMEA/H/C/004214
Source: European Medicines Agency (EMA), product information
Austria
- Tofacitinib DevatisDevatis Gmbh · 1 register entry
- Tofacitinib StadaStadapharm Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- JandarkİLKO İLAÇ SAN.VE TİC. A.Ş. · 1 register entry
- JantyABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- PhorlanDR. SERTUS İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
- TofanziSABA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- TofenolPHARMAPLACE İLAÇ TİC. A.Ş. · 1 register entry
- TofikWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- TojantuKOÇSEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- TositinATABAY KİMYA SAN. VE TİC. A.Ş. · 2 register entries
- XeljanzPFİZER PFE İLAÇLARI A.Ş. · 2 register entries
- XlitenSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 16 more European countries
- Belgium
- Tofacitinib Eg
- Bulgaria
- Tофацитиниб Devatis
- Croatia
- Tofacitinib Accord, Tofacitinib Corapharm, Tofacitinib Stada
- Czechia
- Tofacitinib Stada
- Denmark
- Tofacitinib Accord, Tofacitinib Newbury
- Finland
- Tofacitinib Devatis, Tofacitinib Stada
- France
- Tofacitinib Stada
- Iceland
- Xeljanz
- Ireland
- Tofacitinib Stada
- Liechtenstein
- Xeljanz
- Malta
- Tofacitinib Stada
- Netherlands
- Tofacitinib Accord, Tofacitinib Devatis, Tofacitinib Stada
- Norway
- Tofacitinib Accord, Tofacitinib Devatis, Tofacitinib Newbury, Xeljanz
- Portugal
- Tofacitinib Bluepharma, Tofacitinib Stada
- Spain
- Tofacitinib Stada
- Sweden
- Jaktify, Tofacitinib Devatis, Tofacitinib Newbury, Tofacitinib Stada
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
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Sources
- European Medicines Agency. Xeljanz – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/xeljanz-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L04AF.
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.