- Left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, cardiac death, and asymptomatic decline in left ventricular ejection fraction have been reported in patients receiving trastuzumab
- Withhold therapy if
16% absolute decrease in LVEF from pretreatment values or an LVEF value below institutional limits of normal and 10% absolute decrease in LVEF from pretreatment values - Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan during treatment
- Infusion reactions including fever and chills, nausea, vomiting, pain, headache, dizziness, dyspnea, hypotension, rash, and asthenia have been reported with trastuzumab. Discontinue the drug if patient experiences severe infusion reaction.
- Exposure to therapy during pregnancy may result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death [US Black Box Warning]
- Serious and fatal pulmonary toxicity which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency, hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis have been reported with trastuzumab; however, patients with symptomatic intrinsic lung disease, extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
- Neutropenia and febrile neutropenia have been reported in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone
- Detection of HER2 protein overexpression is necessary for selection of patients appropriate for trastuzumab therapy
Caution: Use cautiously in
- Hypersensitivity to hamster proteins
- Prior or concurrent cardiotoxic treatment
- Prior or concurrent antihypertensive treatment
- Symptomatic intrinsic lung disease
- Lung metastases
- Elderly patients
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