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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) or ILD-like reactions (eg, lung infiltration, pneumonitis, acute respiratory distress syndrome, or pulmonary fibrosis) occurred in 1.3% of 2462 IRESSA patients; of these, 0.7% were Grade ≥3 and 3 cases were fatal. Withhold IRESSA and promptly investigate for ILD in any patient who presents with worsening of respiratory symptoms such as dyspnea, cough and fever. Permanently discontinue IRESSA if ILD is confirmed
  • In patients who received IRESSA, 11.4% of patients had increased alanine aminotransferase (ALT), 7.9% of patients had increased aspartate aminotransferase (AST), and 2.7% of patients had increased bilirubin. Grade ≥3 liver test abnormalities occurred in 5.1% ALT, 3.0% AST, and 0.7% bilirubin of patients. The incidence of fatal hepatotoxicity was 0.04%. Obtain periodic liver function testing. Withhold IRESSA in patients with worsening liver function and discontinue in patients with severe hepatic impairment
  • Gastrointestinal perforation occurred in three (0.1%) of 2462 IRESSA patients. Permanently discontinue IRESSA in patients who develop gastrointestinal perforation
  • Grade ≥ 3 diarrhea occurred in 3% of 2462 IRESSA patients. Withhold IRESSA for severe or persistent (up to 14 days) diarrhea
  • Ocular disorders [keratitis (0.1%), corneal erosion and aberrant eyelash growth (0.2%), conjunctivitis, blepharitis and dry eye (6.7%)] occurred in 2462 IRESSA patients. The incidence of Grade 3 ocular disorders was 0.1%. Interrupt or discontinue IRESSA for severe or worsening ocular disorders
  • Bullous conditions including toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme have been reported from treatment with IRESSA. Erythema multiforme and dermatitis bullous have been reported in two patients (0.08%) across NSCLC trials. IRESSA treatment should be interrupted or discontinued if patients develop severe bullous, blistering or exfoliating conditions
  • Based on its mechanism of action and data from animal reproduction studies IRESSA can cause fetal harm when administered to a pregnant woman. In animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IRESSA and for at least two weeks following completion of therapy
  • Advise women to discontinue breast-feeding during treatment with IRESSA
  • The most commonly reported adverse drug reactions reported in more than 20% of patients and greater than placebo, were skin reactions (47%) and diarrhea (29%)

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) or ILD-like reactions (eg, lung infiltration, pneumonitis, acute respiratory distress syndrome, or pulmonary fibrosis) occurred in 1.3% of 2462 IRESSA patients; of these, 0.7% were Grade ≥3 and 3 cases were fatal. Withhold IRESSA and promptly investigate for ILD in any patient who presents with worsening of respiratory symptoms such as dyspnea, cough and fever. Permanently discontinue IRESSA if ILD is confirmed
  • In patients who received IRESSA, 11.4% of patients had increased alanine aminotransferase (ALT), 7.9% of patients had increased aspartate aminotransferase (AST), and 2.7% of patients had increased bilirubin. Grade ≥3 liver test abnormalities occurred in 5.1% ALT, 3.0% AST, and 0.7% bilirubin of patients. The incidence of fatal hepatotoxicity was 0.04%. Obtain periodic liver function testing. Withhold IRESSA in patients with worsening liver function and discontinue in patients with severe hepatic impairment
  • Gastrointestinal perforation occurred in three (0.1%) of 2462 IRESSA patients. Permanently discontinue IRESSA in patients who develop gastrointestinal perforation
  • Grade ≥ 3 diarrhea occurred in 3% of 2462 IRESSA patients. Withhold IRESSA for severe or persistent (up to 14 days) diarrhea
  • Ocular disorders [keratitis (0.1%), corneal erosion and aberrant eyelash growth (0.2%), conjunctivitis, blepharitis and dry eye (6.7%)] occurred in 2462 IRESSA patients. The incidence of Grade 3 ocular disorders was 0.1%. Interrupt or discontinue IRESSA for severe or worsening ocular disorders
  • Bullous conditions including toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme have been reported from treatment with IRESSA. Erythema multiforme and dermatitis bullous have been reported in two patients (0.08%) across NSCLC trials. IRESSA treatment should be interrupted or discontinued if patients develop severe bullous, blistering or exfoliating conditions
  • Based on its mechanism of action and data from animal reproduction studies IRESSA can cause fetal harm when administered to a pregnant woman. In animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IRESSA and for at least two weeks following completion of therapy
  • Advise women to discontinue breast-feeding during treatment with IRESSA
  • The most commonly reported adverse drug reactions reported in more than 20% of patients and greater than placebo, were skin reactions (47%) and diarrhea (29%)

Please see accompanying complete Prescribing Information including Patient Information.