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upadacitinib

Rinvoq · ATC code L04AA44

Key facts
Active substance
upadacitinib
Drug class
Immunosuppressive drug
ATC code
L04AA44
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
RINVOQ 15 mg prolonged-release tablets / RINVOQ 30 mg prolonged-release tablets / RINVOQ 45 mg prolonged-release tablets · RINVOQ 1 mg/ml oral solution
Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
Information as of
2026-10-27

Key facts

Upadacitinib is a selective Janus kinase (JAK) inhibitor (Rinvoq). It is used for inflammatory rheumatic diseases, atopic dermatitis, alopecia areata, vitiligo and inflammatory bowel disease.

What it is used for

  • Rheumatoid arthritis and psoriatic arthritis in adults after inadequate response to DMARDs
  • Polyarticular juvenile idiopathic arthritis from 2 years of age
  • Axial spondyloarthritis (nr-axSpA and ankylosing spondylitis); giant cell arteritis in adults
  • Atopic dermatitis, severe alopecia areata and non-segmental vitiligo from 12 years of age
  • Moderately to severely active ulcerative colitis and Crohn's disease in adults

Dosing

  • RA, PsA, axSpA and giant cell arteritis: 15 mg once daily (in giant cell arteritis with tapering corticosteroids)
  • Atopic dermatitis: 15 mg or 30 mg once daily; 15 mg for patients at higher risk of VTE, MACE and malignancy
  • Ulcerative colitis: induction 45 mg once daily for 8 weeks, maintenance 15 mg or 30 mg; Crohn's disease in the full text
  • pJIA by body weight (oral solution twice daily or 15 mg tablet); tablets and solution are not interchangeable
  • 65 years and older: 15 mg once daily
  • Do not start if ALC < 0.5 x 10⁹ cells/L, ANC < 1 x 10⁹ cells/L or Hb < 8 g/dL; lower doses with strong CYP3A4 inhibitors

Contraindications

  • Hypersensitivity to the active substance or any of the excipients
  • Active tuberculosis or active serious infections
  • Severe hepatic impairment
  • Pregnancy

Important warnings

  • In patients 65 years and older, with cardiovascular risk factors or malignancy risk, use only if no suitable alternatives exist
  • Serious infections; interrupt treatment during a serious infection
  • Venous thromboembolism (DVT, pulmonary embolism)
  • Not combined with other potent immunosuppressants or JAK inhibitors
  • Monitor blood counts, liver tests and lipids

Side effects

  • RA/PsA/axSpA (15 mg): upper respiratory tract infections (19.5%), CPK increased (8.6%), ALT increased (4.3%), bronchitis (3.9%), nausea (3.5%)
  • Atopic dermatitis: upper respiratory tract infection (25.4%), acne (15.1%), herpes simplex (8.4%), headache (6.3%)
  • Neutropenia, hypercholesterolaemia
  • Serious: serious infections, venous thromboembolism

Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, grapefruit) increase exposure; caution or dose adjustment
  • Strong CYP3A4 inducers may decrease exposure

Pregnancy and breastfeeding

  • Contraindicated in pregnancy (teratogenic in animals)
  • Effective contraception during treatment and for 4 weeks after the final dose

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 →

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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)

  • RinvoqAbbVie Deutschland GmbH & Co. KG · EMEA/H/C/004760

Source: European Medicines Agency (EMA), product information

Turkey

  • RinvoqABBVİE TIBBİ İLAÇLAR 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
Rinvoq
Liechtenstein
Rinvoq
Norway
Rinvoq

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.

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Sources

  1. European Medicines Agency. Rinvoq – 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/rinvoq-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L04AA.

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.