INDICATIONS AND USAGE（适应症）

IRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.

DOSAGE（服用剂量）

Select patients for the first-line treatment of metastatic NSCLC with IRESSA based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations in their tumor or plasma specimens. If these mutations are not detected in a plasma specimen, test tumor tissue if feasible.

Recommended Dose

The recommended dose of IRESSA is 250 mg orally once daily with or without food until disease progression or unacceptable toxicity.

Do not take a missed dose within 12 hours of the next dose.

ADVERSE REACTIONS（不良反应）

Interstitial Lung Disease

Hepatotoxicity

Gastrointestinal Perforation

Severe or Persistent Diarrhea

Ocular Disorders including Keratitis

Bullous and Exfoliative Skin Disorders

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/827d60e8-7e07-41b7-c28b-49ef1c4a5a41/spl-doc?hl=Gefitinib

Iressainformation