MedeliX
Start asking

gefitinib

Iressa · ATC code L01XE02

Brand names: Iressa, Gefitinib Accord, Gefitinib Genthon, Gefitinib Ratiopharm, Gefitinib Stada, Gefira

Key facts
Active substance
gefitinib
Drug class
ALK inhibitor
ATC code
L01XE02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
IRESSA 250 mg film-coated tablets
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-28

Key facts

Gefitinib (Iressa) is an oral EGFR tyrosine kinase inhibitor for locally advanced or metastatic non-small cell lung cancer with activating EGFR mutations.

What it is used for

  • Monotherapy for adults with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK.
  • EGFR mutation assessment of tumour tissue (or plasma ctDNA) should be attempted before treatment.

Dosing

  • One 250 mg tablet once a day, with or without food, at about the same time each day.
  • Take a missed dose when remembered unless it is less than 12 hours to the next dose; never take a double dose.
  • For poorly tolerated diarrhoea or skin reactions, a brief interruption (up to 14 days) followed by reinstatement of 250 mg.
  • No dose adjustment with creatinine clearance > 20 ml/min or based on age; monitor closely in moderate to severe hepatic impairment due to cirrhosis and in CYP2D6 poor metabolisers.
  • The tablet can be dispersed in water or given via a tube.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Breast-feeding.

Important warnings

  • Interstitial lung disease (1.3% of patients), sometimes fatal; interrupt if respiratory symptoms worsen, discontinue if confirmed.
  • Hepatotoxicity: periodic liver function testing.
  • Keratitis: refer promptly to an ophthalmologist for eye symptoms.
  • With warfarin, monitor PT or INR regularly.

Side effects

  • Most frequent (in more than 20%): diarrhoea and skin reactions (rash, acne, dry skin, pruritus), usually within the first month and reversible.
  • Approximately 8% of patients had a severe reaction (grade 3 or 4); approximately 3% stopped therapy because of a reaction.
  • Interstitial lung disease in 1.3%, often severe, some fatal.

Interactions

  • Avoid CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampicin, barbiturates, St John's wort) – reduced efficacy.
  • Proton-pump inhibitors and H2-antagonists may reduce bioavailability.
  • Warfarin: INR elevations and bleeding events reported.

Pregnancy and breastfeeding

  • Should not be used in pregnancy unless clearly necessary; women should not become pregnant during therapy.
  • Contraindicated during breast-feeding.

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.

Full official text →

Common questions – ask Medelix

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)

  • IressaAstraZeneca AB · EMEA/H/C/001016

Source: European Medicines Agency (EMA), product information

Austria

  • Gefitinib AccordAccord Healthcare B.V. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Gefitinib AccordAccord Healthcare B.V. · 1 register entry
  • Gefitinib GenthonGenthon Bv · 1 register entry
  • Gefitinib RatiopharmRatiopharm Gmbh · 1 register entry
  • Gefitinib StadaStadapharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • GefiraTEVA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • IressaASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry

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

Brand names in 25 more European countries
Belgium
Gefitinib Accord, Gefitinib Sandoz
Bulgaria
Фромпо
Croatia
Gefitinib Pliva, Gefitinib Sandoz, Phrompo
Cyprus
Refetib
Czechia
Gefitinib Accord
Denmark
Gefitinib Accord, Gefitinib Stada
Estonia
Gefitinib Auxilia, Gefitinib Norameda
Finland
Gefitinib Accord, Gefitinib Stada
France
Gefitinib Biogaran, Gefitinib Cristers, Gefitinib Eg, Gefitinib Genthon, Gefitinib Sandoz, Gefitinib Teva, Gefitinib Zentiva
Greece
Gefitinib Faran, Gefitinib Genepharm, Gefitinib Innovis
Hungary
Gefitinib Genepharm, Gefitinib Onkogen, Gefitinib Pharmacenter, Gefitinib Pharmascience, Gefitinib Stada, Gefitinib Teva
Iceland
Gefitinib Stada, Gefitinib Wh, Iressa
Italy
Gefitinib Medac
Latvia
Gefitinib Norameda
Liechtenstein
Iressa
Lithuania
Gefitinib Norameda
Malta
Gefitinib Eugia, Gefitinib Genthon
Netherlands
Gefitinib Eugia, Gefitinib Genthon, Gefitinib Glenmark, Gefitinib Sandoz, Gefitinib Stada, Gefitinib Synthon, Gefitinib Teva
Norway
Gefitinib Stada, Iressa
Poland
Gefitinib Accord, Gefitinib Genthon, Gefitinib Sandoz
Portugal
Gefitinib Accord, Gefitinib Eugia, Gefitinib Generis, Gefitinib Stada, Gefitinib Zentiva
Romania
Gefitinib Accord, Gefitinib Polisano, Phrompo
Slovenia
Phrompo
Spain
Gefitinib Efg Genthon, Gefitinib Eugia, Gefitinib Qilu, Gefitinib Sandoz, Gefitinib Teva
Sweden
Gefitinib Accord, Gefitinib Stada

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. Iressa – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/iressa-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC L01XE.

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.