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Important Safety Information

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  • There are no contraindications..
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  • There are no contraindications for IRESSA
  • Interstitial Lung Disease (ILD): ILD occurred in patients taking IRESSA. Withhold IRESSA for worsening of respiratory symptoms. Discontinue IRESSA if ILD is confirmed
  • Hepatotoxicity: Obtain periodic liver function testing. Withhold IRESSA for Grade 2 or higher for alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations. Discontinue for severe hepatic impairment
  • Gastrointestinal Perforation: Discontinue IRESSA for gastrointestinal perforation
  • Diarrhea: Withhold IRESSA for Grade 3 or higher diarrhea
  • Ocular Disorders Including Keratitis: Withhold IRESSA for signs and symptoms of severe or worsening ocular disorders including keratitis. Discontinue for persistent ulcerative keratitis
  • Bullous and Exfoliative Skin Disorders: Withhold IRESSA for Grade 3 or higher skin reactions or exfoliative conditions
  • Embryo-fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception
  • Advise women to discontinue breast-feeding during treatment with IRESSA
  • The most commonly reported adverse drug reactions, reported in more than 20% of the patients and greater than placebo, were skin reactions and diarrhea

Please see complete Prescribing Information, including Patient Information.

CONTACT US

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If you would like additional information regarding AstraZeneca products, please contact the Information Center at AstraZeneca in the US at 1-800-236-9933, Monday through Friday, 8 AM to 6 PM ET, excluding holidays.

Indication

IRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.

Important Safety Information

  • There are no contraindications for IRESSA
  • Interstitial Lung Disease (ILD): ILD occurred in patients taking IRESSA. Withhold IRESSA for worsening of respiratory symptoms. Discontinue IRESSA if ILD is confirmed
  • Hepatotoxicity: Obtain periodic liver function testing. Withhold IRESSA for Grade 2 or higher for alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations. Discontinue for severe hepatic impairment
  • Gastrointestinal Perforation: Discontinue IRESSA for gastrointestinal perforation
  • Diarrhea: Withhold IRESSA for Grade 3 or higher diarrhea
  • Ocular Disorders Including Keratitis: Withhold IRESSA for signs and symptoms of severe or worsening ocular disorders including keratitis. Discontinue for persistent ulcerative keratitis
  • Bullous and Exfoliative Skin Disorders: Withhold IRESSA for Grade 3 or higher skin reactions or exfoliative conditions
  • Embryo-fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception
  • Advise women to discontinue breast-feeding during treatment with IRESSA
  • The most commonly reported adverse drug reactions, reported in more than 20% of the patients and greater than placebo, were skin reactions and diarrhea

Please see accompanying complete Prescribing Information, including Patient Information.