Cardiomyopathy; Infusion Reactions, Pulmonary Toxicity;  Embryo Fetal Toxocity

Cardiomyopathy

• Trastuzumab administration can result in sub-clinical and clinical cardiac failure manifesting as CHF and decreased left ventricular ejection fraction (LVEF).
• Left ventricular function should be evaluated in all patients prior to and during treatment with trastuzumab.
• The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received the drug concurrently with anthracycline containing chemotherapy regimens.
• Discontinue trastuzumab treatment in patients receiving adjuvant therapy for breast cancer and strongly consider discontinuation of trastuzumab in patients with metastatic breast cancer who develop a clinically significant decrease in left ventricular function. 

Infusion Reactions, Pulmonary Toxicity

• Trastuzumab administration can result in serious infusion reactions and pulmonary toxicity.
• Fatal infusion reactions have been reported.
• In most cases, symptoms occurred during or within 24 hours of administration of trastuzumab.
• Trastuzumab infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension.
• Patients should be monitored until signs and symptoms completely resolve.
• Discontinue trastuzumab for anaphylaxis, angloedema, interstitial pneumonitis or acute respiratory distress syndrome.

Embryo-Fetal Toxicity

• Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception