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risankizumab

Skyrizi · ATC code L04AC18

Key facts
Active substance
risankizumab
Drug class
Immunosuppressive drug
ATC code
L04AC18
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Skyrizi 150 mg solution for injection in pre-filled pen / Skyrizi 150 mg solution for injection in pre-filled syringe / Skyrizi 75 mg solution for injection in pre-filled syringe · Skyrizi 55 mg solution for injection in pre-filled syringe · Skyrizi 600 mg concentrate for solution for infusion · Skyrizi 360 mg solution for injection in cartridge / Skyrizi 180 mg solution for injection in cartridge / Skyrizi 180 mg solution for injection in pre-filled syringe · Skyrizi 90 mg solution for injection in pre-filled syringe
Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
Information as of
2026-10-27

Key facts

Risankizumab (Skyrizi) is a monoclonal antibody. It is used for plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

What it is used for

  • Moderate to severe plaque psoriasis in adults and in children and adolescents from 6 years who are candidates for systemic therapy
  • Active psoriatic arthritis in adults after inadequate response to DMARDs, alone or with methotrexate
  • Moderately to severely active Crohn's disease and ulcerative colitis in adults with inadequate response, loss of response or intolerance to conventional or biologic therapy

Dosing

  • Adult plaque psoriasis and psoriatic arthritis: 150 mg subcutaneously at week 0, week 4 and every 12 weeks thereafter
  • Paediatric plaque psoriasis from 6 years: <40 kg 55 mg, ≥40 kg 150 mg, same schedule
  • Crohn's disease: 600 mg intravenously at weeks 0, 4 and 8, then 360 mg subcutaneously at week 12 and every 8 weeks
  • Ulcerative colitis: 1,200 mg intravenously at weeks 0, 4 and 8, then 180 mg or 360 mg subcutaneously every 8 weeks depending on response
  • Consider stopping if no response after 16 weeks (psoriasis, PsA) or by week 24 (Crohn's, UC)
  • No dose adjustment in the elderly or in renal or hepatic impairment

Contraindications

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

Important warnings

  • May increase the risk of infection; do not administer until a clinically important infection resolves
  • Evaluate for tuberculosis before starting; monitor for active TB during treatment
  • No live vaccines during treatment and for at least 21 weeks after
  • Record name and batch number for traceability

Side effects

  • Most frequent: upper respiratory infections (13.0% in psoriasis)
  • Further adverse reactions by indication in the full product information

Interactions

  • No interactions via drug-metabolising enzymes expected
  • Live vaccines: not during and for at least 21 weeks after treatment

Pregnancy and breastfeeding

  • Women of childbearing potential: effective contraception during and for at least 21 weeks after treatment
  • Limited data; as a precaution preferable to avoid in pregnancy

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)

  • SkyriziAbbVie Deutschland GmbH & Co. KG · EMEA/H/C/004759

Source: European Medicines Agency (EMA), product information

Turkey

  • SkyriziABBVİE TIBBİ İLAÇLAR SAN. VE TİC. LTD. ŞTİ. · 5 register entries

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

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

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

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. Skyrizi – 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/skyrizi-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 L04AC.

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.