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Icotrokinra Hydrochloride

Icotyde · ATC code L04AC28

Key facts
Active substance
Icotrokinra Hydrochloride
Drug class
Immunosuppressive drug
ATC code
L04AC28
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ICOTYDE 200 mg film-coated tablets
Marketing authorisation holder
Janssen-Cilag International
Information as of
2026-10-27

Key facts

Icotrokinra (Icotyde) is an oral medicine that acts on the immune system. It is used to treat moderate to severe plaque psoriasis.

What it is used for

  • Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
  • Adolescents 12 years of age and older weighing at least 40 kg

Dosing

  • Adults and adolescents weighing at least 40 kg: 200 mg orally once daily
  • Taken upon waking on an empty stomach with water, at least 30 min before food; swallow whole
  • For swallowing difficulties the tablet can be dispersed in at least 120 mL of water
  • Consider stopping if no benefit after 24 weeks
  • No dose adjustment in elderly patients or in renal or hepatic impairment; not studied in end-stage renal disease

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; monitor closely and stop treatment until a clinically relevant infection resolves
  • Consider completing age-appropriate immunisations before starting
  • Live vaccines not recommended during treatment and within 3 days after stopping

Side effects

  • Most frequent: fungal infections (1.1%), e.g. tinea pedis, oral candidiasis
  • Uncommon: diverticulitis
  • Safety profile in adolescents consistent with the overall study population

Interactions

  • Live vaccines: not during treatment or within 3 days after stopping
  • In vitro not a CYP or P-gp substrate, inhibitor or inducer; no drug interactions expected

Pregnancy and breastfeeding

  • Limited data; as a precaution, preferable to avoid use during pregnancy
  • Newborns exposed in pregnancy should not receive live vaccines within the first 3 days after birth

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)

  • IcotydeJanssen-Cilag International · EMEA/H/C/006730

Source: European Medicines Agency (EMA), product information

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

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. Icotyde – 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/icotyde-epar-product-information_en.pdf
  2. 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.