The mechanism of clinical antitumor action of erlotinib is not fully characterized. Erlotinib inhibits the intracellular phosphorylation of tyrosine kinase associated with the epidermal growth factor receptor (EGFR). Specificity of inhibition with regard to other tyrosine kinase receptors has not been fully characterized. EGFR is expressed on the cell surface of normal cells and cancer cells.

TARCEVA is a kinase inhibitor indicated for:
• Maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
• Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
• First-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer, in combination with gemcitabine.

• The dose for NSCLC is 150 mg/day.
• The dose for pancreatic cancer is 100 mg/day.
• All doses of TARCEVA should be taken on an empty stomach at least one hour before or two hours after food.
• Reduce in 50 mg decrements, when necessary.

• The most common adverse reactions (>20%) in maintenance treatment are rash-like events and diarrhea.
• The most common adverse reactions (>20%) in 2nd line NSCLC are rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, infection and vomiting.
• The most common adverse reactions (>20%) in pancreatic cancer are fatigue, rash, nausea, anorexia, diarrhea, abdominal pain, vomiting, weight decrease, infection, edema, pyrexia, constipation, bone pain, dyspnea, stomatitis and myalgia.

None.

•Interstitial Lung Disease (ILD)-like events, including fatalities have been infrequently reported. Interrupt TARCEVA if acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever occur. Discontinue TARCEVA if ILD is diagnosed.
• Cases of acute renal failure (including fatalities), and renal insufficiency have been reported. Interrupt TARCEVA in the event of dehydration. Monitor renal function and electrolytes in patients at risk of dehydration.
• Cases of hepatic failure and hepatorenal syndrome (including fatalities) have been reported. Monitor periodic liver function testing. Interrupt or discontinue TARCEVA if liver function changes are severe. See package insert for complete information.