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deucravacitinib

Sotyktu · ATC code L04AF07

Also known as: Deukravasitinib

Key facts
Active substance
deucravacitinib
Drug class
Immunosuppressive drug
ATC code
L04AF07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
SOTYKTU 6 mg film-coated tablets
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Information as of
2026-10-28

Key facts

Deucravacitinib (Sotyktu) is an oral tyrosine kinase 2 (TYK2) inhibitor used for moderate to severe plaque psoriasis and active psoriatic arthritis in adults.

What it is used for

  • Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
  • Active psoriatic arthritis in adults with an inadequate response or intolerance to a prior DMARD, alone or in combination with methotrexate.

Dosing

  • 6 mg orally once daily, with or without food; tablets are swallowed whole and not crushed, cut or chewed.
  • If there is no therapeutic benefit after 24 weeks, discontinuation should be considered.
  • No dose adjustment in renal impairment (including dialysis) or in mild or moderate hepatic impairment; not recommended in severe hepatic impairment.
  • No adjustment from 65 years; caution in patients ≥ 75 years because experience is very limited.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.
  • Clinically important active infections (e.g. active tuberculosis).

Important warnings

  • May increase the risk of infections; caution in chronic or recurrent infections, and treatment is withheld during a clinically important infection.
  • Patients should be screened for tuberculosis before starting; latent TB is treated first.
  • Malignancies including lymphomas and non-melanoma skin cancer were observed; risks and benefits should be considered before starting.
  • It is not known whether TYK2 inhibition shares the risks of JAK inhibitors (MACE, deep venous thrombosis, pulmonary embolism, malignancies).
  • Age-appropriate immunisations should be completed before treatment; live vaccines should be avoided.

Side effects

  • Very common: upper respiratory infections (18.9% in plaque psoriasis studies and 15.1% in psoriatic arthritis studies).
  • Common: herpes simplex infections, oral ulcers, acneiform rash, folliculitis, blood creatine phosphokinase increased.
  • Uncommon: pneumonia, herpes zoster, bronchitis.

Interactions

  • No clinically relevant interactions with rosuvastatin, methotrexate, mycophenolate mofetil, metformin or oral contraceptives.
  • Cyclosporine, fluvoxamine, ritonavir, diflunisal, pyrimethamine, famotidine and rabeprazole do not meaningfully affect deucravacitinib exposure.

Pregnancy and breastfeeding

  • As a precaution, use during pregnancy is preferably avoided.
  • Excreted in breast milk (about 12% of the maternal dose); a decision on breast-feeding or therapy is required.

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.

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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)

  • SotyktuBristol-Myers Squibb Pharma EEIG · EMEA/H/C/005755

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Sotyktu
Liechtenstein
Sotyktu
Norway
Sotyktu

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?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Sotyktu – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/sotyktu-epar-product-information_en.pdf
  2. 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.