Iressa

[gefitinib tablets]

Pregnancy

Pregnancy Category D (see WARNINGS and PRECAUTIONS-Information for Patients sections).

Nursing Mothers

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It is not known whether IRESSA is excreted in human milk. Following oral adminis-tration of carbon-14 labeled gefitinib to rats 14 days postpartum, concentrations of radioactivity in milk were higher than in blood. Levels of gefitinib and its metabolites were 11- to- 19- fold higher in milk than in blood, after oral exposure of lactating rats to a dose of 5 mg/ kg. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should be advised against breast- feeding while receiving IRESSA therapy.

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.

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