Afatinib

What it is used for

GILOTRIF is a kinase inhibitor indicated for: 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: Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy 1.1 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.

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Diarrhea
• Bullous and Exfoliative Skin Disorders
• Interstitial Lung Disease
• Hepatic Toxicity
• Gastrointestinal Perforation
• Keratitis

Who should not take it

None.

Storing it

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense medication in the original container to protect from exposure to high humidity and light.