INDICATIONS AND USAGE（适应症）

EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer

GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

Limitations of Use: The safety and efficacy of GILOTRIF have not been established in patients whose tumors have resistant EGFR mutations.

Previously Treated, Metastatic Squamous NSCLC

GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

DOSAGE（服用剂量）

The recommended dosage of GILOTRIF is 40 mg orally once daily until disease progression or no longer tolerated by the patient.

Take GILOTRIF at least 1 hour before or 2 hours after a meal.

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

ADVERSE REACTIONS（不良反应）

Diarrhea

Bullous and Exfoliative Skin Disorders

Interstitial Lung Disease

Hepatic Toxicity

Gastrointestinal Perforation

Keratitis

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/fd638e5e-8032-e7ca-0179-95e96ab5d387/spl-doc?hl=afatinib

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