Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Toxicological Effects
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Substrate of
  • Inhibits
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names


Austria: Iressa; Bulgaria: Iressa; Czech Republic: Iressa; Denmark: Iressa; Estonia: Iressa; Finland: Iressa; Germany: Iressa; Greece: Iressa; Hungary: Iressa; Ireland: Iressa; Latvia: Iressa; Lithuania: Iressa; Malta: Iressa; Netherlands: Iressa; Portugal: Iressa; Romania: Iressa; Slovakia: Iressa; Slovenia: Iressa; Sweden: Iressa; UK: Iressa.

North America

USA: Iressa.

Latin America

Mexico: Iressa.


Japan: Iressa.

Drug combinations


Gefitinib: C~22~H~24~ClFN~4~O~3~. Mw: 446.90. 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-4-morpholin)propoxy]-. CAS-184475-35-2 (2002).

Pharmacologic Category

Other Antineoplastic Agents; Protein Kinase Inhibitors. Tyrosine Kinase Inhibitor. (ATC-Code: L01XE02).

Mechanism of action

Mechanism of antineoplastic action not fully understood. Gefitinib inhibits tyrosine kinases (TK) associated with transmembrane cell surface receptors found on both normal and cancer cells. One such receptor is epidermal growth factor receptor. TK activity appears to be vitally important to cell proliferation and survival.

Therapeutic use

Treatment of locally advanced or metastatic non-small cell lung cancer after failure of platinum-based and docetaxel therapies. Treatment limited to patients who are benefiting or have benefited from treatment with gefitinib.

Pregnancy and lactiation implications

Animal studies demonstrated fetal harm. There are no well-controlled studies in pregnant women.

Unlabeled use


Hypersensitivity to gefitinib or any component of the formulation. Pregnancy.

Warnings and precautions

Hazardous agent. Interruption of therapy may be required in poorly tolerated diarrhea. Eye pain might occur. Rare, sometimes fatal, pulmonary toxicity (e.g. alveolitis, interstitial pneumonia, pneumonitis) reported. Risk of increased mortality in patients with concurrent idiopathic pulmonary fibrosis whose condition worsens while receiving gefitinib. Adverse skin reactions reported (angioedema and urticaria). Hemorrhage (e.g. epistaxis, hematuria) and pancreatitis (rarely) reported. Use with caution in hepatic impairment (may cause hepatic injury and elevation of transaminases). Use with caution in severe renal impairment. Asymptomatic elevations of hepatic aminotransferase concentrations reported.



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