Iressa

[gefitinib tablets]

Indications & Dosage
INDICATIONS AND USAGE

IRESSA is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies. The effectiveness of IRESSA is based on objective response rates (see CLINICAL PHARMACOLOGY -Clinical Studies section).

There are no controlled trials demonstrating a clinical benefit, such as improvement in disease- related symptoms or increased survival. Results from two large, controlled, randomized trials in first-line treatment of non-small cell lung cancer showed no benefit from adding IRESSA to doublet, platinum-based chemotherapy. Therefore, IRESSA is not indicated for use in this setting.

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DOSAGE AND ADMINISTRATION

The recommended daily dose of IRESSA is one 250 mg tablet with or without food. Higher doses do not give a better response and cause increased toxicity. F. P. O. IRESSA(r) (gefitinib tablets) 64202-00 Rev 05/ 03 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 By: AstraZeneca UK Limited Macclesfield, Cheshire, England Made in the United Kingdom

Dosage Adjustment Patients with poorly tolerated diarrhea (sometimes associated with dehydration) or skin adverse drug reactions may be successfully managed by providing a brief (up to 14 days) therapy interruption followed by reinstatement of the 250 mg daily dose. In the event of acute onset or worsening of pulmonary symptoms (dyspnea, cough, fever), IRESSA therapy should be interrupted and a prompt investigation of these symptoms should occur and appropriate treatment initiated. If interstitial lung disease is confirmed,

IRESSA should be discontinued and the patient treated appro-priately (see WARNINGS-Pulmonary Toxicity, PRECAUTIONS-Information for Patients and ADVERSE REACTIONS sections). Patients who develop onset of new eye symptoms such as pain should be medically evaluated and managed appropriately, including IRESSA therapy interruption and removal of an aberrant eyelash if present. After symptoms and eye changes have resolved, the decision should be made concerning reinstatement of the 250 mg daily dose (see PRECAUTIONS-Information for Patients and ADVERSE REACTIONS sections).

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