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TARCEVA (ERLOTINIB): PATIENT COUNSELING INFORMATION
If the following signs or symptoms occur, patients should be advised to seek medical advice promptly.
Onset or worsening of skin rash
Onset or worsening of unexplained shortness of breath or cough
Severe or persistent diarrhea, nausea, anorexia, or vomiting
Given that skin reactions are anticipated when taking Erlotinib (Tarceva), proactive intervention may include alcohol-free emollient cream and use of sunscreen or avoidance of sun exposure. 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 (Erlotinib Hydrochloride).
Smokers should be advised to stop smoking while taking Erlotinib Hydrochloride (Tarceva) tablets as plasma concentrations of erlotinib are reduced due to the effect of cigarette smoking.
Manufactured for: OSI Pharmaceuticals Inc.
Manufactured by: Schwarz Pharma Manufacturing
Distributed by: Genentech USA, Inc., the division of Roche, Inc.
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