Iressa - Warnings & Precautions

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Pediatric Use

Safety and effectiveness of IRESSA in pediatric patients have not been studied.

Geriatric Use

Of the total number of patients participating in trials of second-and third-line IRESSA treatment of NSCLC, 65% were aged 64 years or less, 30.5% were aged 65 to 74 years, and 5% of patients were aged 75 years or older. No differences in safety or efficacy were observed between younger and older patients.

Patients with Severe Renal Impairment

The effect of severe renal impairment on the pharmacokinetics of gefitinib is not known. Patients with severe renal impairment should be treated with caution when given IRESSA.