WARNINGS:
CARDIOMYOPATHY
HERCEPTIN administration can result in the development of ventricular dysfunction and congestive heart failure. Left ventricular function should be evaluated in all patients prior to and during treatment with HERCEPTIN. Discontinuation of HERCEPTIN treatment should be strongly considered in patients who develop a clinically significant decrease in left ventricular function. The incidence and severity of cardiac dysfunction was particularly high in patients who received HERCEPTIN in combination with anthracyclines and cyclophosphamide. (See WARNINGS.)
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHY-LAXIS
INFUSION REACTIONS PULMONARY EVENTS
HERCEPTIN administration can result in severe hypersensitivity reactions (including anaphylaxis), infusion reactions, and pulmonary events. Rarely, these have been fatal. In most cases, symptoms occurred during or within 24 hours of administration of HERCEPTIN. HERCEPTIN infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinuation of HERCEPTIN treatment should be strongly considered for patients who develop anaphylaxis, angioedema, or acute respiratory distress syndrome. (See WARNINGS.)
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