IMPORTANT SAFETY INFORMATION
IRESSA is approved in the United States under sub-part H for use as monotherapy for the continued treatment of patients with locally advanced or metastatic non—small-cell lung cancer (NSCLC) after failure of both platinum-based and docetaxel chemotherapies who are benefiting or have benefited from IRESSA. For other patients, in light of positive survival data with other agents, physicians should use other treatment options. The effectiveness of IRESSA was initially based on objective response rates. Subsequent studies intended to demonstrate an increase in survival have been unsuccessful.
The most frequent drug-related adverse events associated with IRESSA were diarrhea (48%) sometimes associated with dehydration, rash (43%), acne (25%), dry skin (13%), nausea (13%), and vomiting (12%). These events generally occurred within the first month of therapy and usually were mild to moderate. 2% of patients stopped taking IRESSA due to an adverse drug reaction. Infrequent cases (about 1%) of interstitial lung disease (ILD—described as interstitial pneumonia, pneumonitis, and alveolitis) have been observed in patients receiving IRESSA. Approximately 1/3 of the ILD cases were fatal. When ILD occurred, it was often accompanied by acute onset of breathing difficulty with cough or low-grade fever requiring hospitalization. IRESSA may cause fetal harm if administered to a pregnant woman. Asymptomatic increases in liver enzymes and eye irritation have also been observed in patients receiving IRESSA. Increases in bleeding events have been observed in cancer patients taking warfarin and IRESSA.
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