Iressa

[gefitinib tablets]

Side Effects & Drug Interactions
ADVERSE REACTIONS

The safety database includes 941 patients from clinical trials and approximately 23,000 patients in the Expanded Access Program. Table 3 includes drug- related adverse events with an incidence of >5% for the 216 patients who received either 250 mg or 500 mg of IRESSA monotherapy for treatment of NSCLC.

The most common adverse events reported at the recom-mended 250 mg daily dose were diarrhea, rash, acne, dry skin, nausea, and vomiting (see PRECAUTIONS-Information for Patients and DOSAGE AND ADMINIS-TRATIONŠ Dosage Adjustment sections). The 500 mg dose showed a higher rate for most of these adverse events. Table 4 provides drug- related adverse events with an incidence of >5% by CTC grade for the patients who received the 250 mg/ day dose of IRESSA monotherapy for treatment of NSCLC. Only 2% of patients stopped therapy due to an adverse drug reaction (ADR). The onset of these ADRs occurred within the first month of therapy.

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Other adverse events reported at an incidence of <5% in patients who received either 250 mg or 500 mg as monotherapy for treatment of NSCLC (along with their frequency at the 250 mg recommended dose) include the following:

peripheral edema (2%),
amblyopia (2%),
dyspnea (2%),
conjunctivitis (1%),
vesiculobullous rash (1%),
mouth ulceration (1%).

Interstitial Lung Disease Cases of interstitial lung disease (ILD) have been observed in patients receiving IRESSA at an overall incidence of about 1%. Approximately 1/ 3 of the cases have been fatal. The reported incidence of ILD was about 2% in the Japanese post-marketing experience, about 0.3% in approximately 23,000 patients treated with IRESSA in a US expanded access program and about 1% in the studies of first-line use in NSCLC (but with similar rates in both treatment and placebo groups). Reports have described the adverse event as interstitial pneumonia, pneumonitis and alveolitis.

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