If the following signs or symptoms occur, patients should be advised to seek medical advice promptly[see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION].

• Onset or worsening of skin rash
• Severe or persistent diarrhea, nausea, anorexia, or vomiting
• Onset or worsening of unexplained shortness of breath or cough
• Eye irritation

Given that skin reactions are anticipated when taking TARCEVA (erlotinib) , proactive intervention may include alcohol-free emollient cream and use of sunscreen or avoidance of sun exposure [see ADVERSE REACTIONS]. The management of rash should be discussed with the patient. This may include topical corticosteroids or antibiotics with anti-inflammatory properties. These approaches were used in the NSCLC and pancreatic pivotal clinical trials. Acne preparations with drying properties may aggravate the dry skin and erythema. Treatment of rash has not been formally studied and should be based on rash severity.

Women of childbearing potential should be advised to avoid becoming pregnant while taking TARCEVA [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

Smokers should be advised to stop smoking while taking TARCEVA as plasma concentrations of erlotinib are reduced due to the effect of cigarette smoking [see CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 5/7/2010
This monograph has been modified to include the generic and brand name in many instances.