Trastuzumab (Herceptin, Genentech) is a monoclonal antibody directed toward HER-2, a receptor tyrosine kinase expressed by certain cancers, including breast and gastric cancers. The drug is administered as an IV infusion. This section discusses adverse reactions, warnings and contraindications associated with trastuzumab treatment.
Common adverse reactions
Warnings and precautions
Drug interactions and other contraindications
Trastuzumab common adverse reactions
Headache, diarrhea, nausea and chills were the most common adverse reactions reported by patients in clinical trials receiving trastuzumab as adjuvant treatment for breast cancer; these events were reported by at least 5% of those receiving trastuzumab.
In clinical trials assessing trastuzumab for the treatment of metastatic breast cancer, at least 10% of participants reported fever, chills, headache, infection, congestive heart failure, insomnia, cough and rash.
More than 10% of clinical trial participants with metastatic gastric adenocarcinoma reported neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infection, fever, thrombocytopenia (low blood platelet count), mucositis, nasopharyngitis and dysgeusia (taste disturbance).
Trastuzumab warnings and precautions
Infusion reaction is a serious and life-threatening risk associated with trastuzumab.
Trastuzumab is also associated with an increased risk for cardiac failure, including congestive heart failure and decreased ejection fraction. The incidence of cardiac failure is higher among those receiving trastuzumab in combination with a chemotherapy regimen containing an anthracycline. All patients should undergo evaluation for left ventricular function before and during treatment with trastuzumab.
Pulmonary toxicity is associated with trastuzumab treatment and may include:
- interstitial pneumonitis;
- pulmonary infiltrates;
- pleural effusions;
- noncardiogenic pulmonary edema;
- pulmonary insufficiency;
- acute respiratory distress syndrome; and
- pulmonary fibrosis.
In clinical trials, patients who received trastuzumab in combination with systemic chemotherapy were more likely to experience neutropenia and febrile neutropenia compared with those receiving only systemic chemotherapy.
Pregnant women should be advised of the fetal toxicity of trastuzumab, which may result in pulmonary hypoplasia, skeletal abnormalities, oligohydramnios and fetal death.
Trastuzumab drug interactions and other contraindications
No known drug interactions or contraindications are associated with trastuzumab. However, HER-2–positive status must be verified before a patient can be treated with trastuzumab.