• Interstitial Lung Disease (ILD)-like events, including fatalities have been infrequently reported. Interrupt Erlotinib if acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever occur. Discontinue Erlotinib if ILD is diagnosed.
• Cases of acute renal failure (including fatalities), and renal insufficiency have been reported. Interrupt Erlotinib 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 Erlotinib if liver function changes are severe.
• Monitor patients with hepatic impairment closely. Interrupt or discontinue Erlotinib if changes in liver function are severe
• Gastrointestinal perforations, including fatalities, have been reported. Discontinue Erlotinib.
• Bullous and exfoliative skin disorders, including fatalities, have been reported. Interrupt or discontinue Erlotinib
• Myocardial infarction/ischemia has been reported, including fatalities, in patients with pancreatic cancer.
• Cerebrovascular accidents, including a fatality, have been reported in patients with pancreatic cancer.
• Microangiopathic Hemolytic Anemia with thrombocytopenia has been reported in patients with pancreatic cancer.
• Corneal perforation and ulceration have been reported. Interrupt or discontinue Erlotinib
• International Normalized Ratio (INR) elevations and bleeding events, some associated with concomitant warfarin administration have been reported. Monitor patients taking warfarin or other coumarin-derivative anticoagulants.
• Erlotinib can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid pregnancy while on Erlotinib.