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tofacitinib

Xeljanz · ATC code L04AF01

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 (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.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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.

Another question about this substance?

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Sources

  1. European Medicines Agency. Xeljanz – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/xeljanz-epar-product-information_en.pdf
  2. 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
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. 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.