Gefitinibdosage

Recommended dose is 250 mg orally, once daily with or without food.

2.1 Patient

Selection Select patients for the first-line treatment of metastatic NSCLC with gefitinib tablets 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. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

2.2 Recommended

Dose The recommended dose of gefitinib tablets 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.

2.3 Administration to

Patients Who Have Difficulty Swallowing Solids Immerse gefitinib tablets in 4 to 8 ounces of water by dropping the tablet in water, and stir for approximately 15 minutes. Immediately drink the liquid or administer through a naso-gastric tube. Rinse the container with 4 to 8 ounces of water and immediately drink or administer through the naso-gastric tube.

2.4 Dose Modification

Dose Modifications for Adverse Drug Reactions Withhold gefitinib tablets (for up to 14 days) for any of the following:

Acute onset or worsening of pulmonary symptoms (dyspnea, cough, fever)

NCI CTCAE Grade 2 or higher in ALT and/or AST elevations

NCI CTCAE Grade 3 or higher diarrhea

Signs and symptoms of severe or worsening ocular disorders including keratitis

NCI CTCAE Grade 3 or higher skin reactions Resume treatment with gefitinib tablets when the adverse reaction fully resolves or improves to NCI CTCAE Grade 1. Permanently discontinue gefitinib tablets for:

Confirmed interstitial lung disease (ILD)

Severe hepatic impairment

Gastrointestinal perforation

Persistent ulcerative keratitis Dose Modifications for Drug Interactions Strong CYP3A4 Inducers Increase gefitinib tablets to 500 mg daily in the absence of severe adverse drug reaction, and resume gefitinib tablets at 250 mg seven days after discontinuation of the strong CYP3A4 inducer.