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baricitinib

Olumiant · ATC code L04AA37

Key facts
Active substance
baricitinib
Drug class
Immunosuppressive drug
ATC code
L04AA37
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Olumiant 1 mg film-coated tablets / Olumiant 2 mg film-coated tablets / Olumiant 4 mg film-coated tablets · Olumiant 2 mg/mL oral suspension
Marketing authorisation holder
Eli Lilly Nederland B.V.
Information as of
2026-10-27

Key facts

Baricitinib is a Janus kinase (JAK) inhibitor. It is used for rheumatoid arthritis, atopic dermatitis, alopecia areata and juvenile idiopathic arthritis.

What it is used for

  • Moderate to severe active rheumatoid arthritis in adults with inadequate response or intolerance to DMARDs, as monotherapy or with methotrexate
  • Moderate to severe atopic dermatitis in adults and children 2 years and older who are candidates for systemic therapy
  • Severe alopecia areata in adults and adolescents 12 years and older
  • Active juvenile idiopathic arthritis from 2 years (polyarticular, enthesitis-related, juvenile psoriatic arthritis) after inadequate response to DMARDs

Dosing

  • Rheumatoid arthritis and atopic dermatitis (adults): 4 mg once daily
  • 2 mg once daily for patients at higher risk of VTE, MACE and malignancy, aged ≥65 years, or with chronic or recurrent infections
  • Tapering to 2 mg may be considered after sustained disease control on 4 mg
  • Atopic dermatitis in children 2 years and older: 4 mg once daily at 30 kg or more; 2 mg once daily at 10 kg to less than 30 kg
  • Atopic dermatitis: consider stopping if no benefit after 8 weeks
  • Oral suspension 2 mg/mL: 2 mg = 1 mL, 4 mg = 2 mL; further regimens (e.g. alopecia areata, renal function) in the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Pregnancy

Important warnings

  • Use only if no suitable alternatives exist in patients 65 years and older, with atherosclerotic cardiovascular disease or other cardiovascular risk factors (e.g. smoking), or with malignancy risk factors
  • Increased risk of MACE, malignancies, serious infections and all-cause mortality in patients 65 and older (seen with tofacitinib, another JAK inhibitor)
  • Serious, sometimes fatal infections, including opportunistic infections, with JAK inhibitors
  • Increased rate of infections (e.g. upper respiratory tract); higher when combined with methotrexate

Side effects

  • Most common: increased LDL cholesterol (26.0%), upper respiratory tract infections (16.9%), headache (5.2%), herpes simplex (3.2%), urinary tract infections (2.9%)
  • Uncommon but serious: pneumonia and herpes zoster
  • Others: thrombocytosis, neutropenia, gastroenteritis, urticaria

Interactions

  • Combination with biological DMARDs or other JAK inhibitors not studied
  • Potent immunosuppressants (e.g. azathioprine, tacrolimus, ciclosporin): additive immunosuppression cannot be excluded; not recommended in atopic dermatitis and alopecia areata

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; teratogenic in animal studies
  • Women of childbearing potential must use effective contraception during and for at least 1 week after treatment

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)

  • OlumiantEli Lilly Nederland B.V. · EMEA/H/C/004085

Source: European Medicines Agency (EMA), product information

Turkey

  • UnamityLİLLY İLAÇ TİC. LTD. ŞTİ. · 12 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 4 more European countries
Iceland
Olumiant
Liechtenstein
Olumiant
Norway
Olumiant
Portugal
Baricitinib Generis

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. Olumiant – 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/olumiant-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.