Trastuzumab (Intravenous)

Trastuzumab can result in subclinical and clinical cardiac failure, with the greatest risk and severity upon concurrent administration with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab in patients receiving adjuvant therapy and withhold trastuzumab for a clinically significant decrease in left ventricular function. Serious and fatal infusion reactions and pulmonary toxicity may occur during or within 24 hours after administration. Discontinue trastuzumab if signs of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome are noted. Exposure during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception .

CardiomyopathyAdministration of trastuzumab products can result in subclinical and clinical cardiac failure. The incidence and severity were highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with trastuzumab-qyyp. Discontinue trastuzumab-qyyp treatment in patients receiving adjuvant therapy and withhold trastuzumab-qyyp in patients with metastatic disease for clinically significant decrease in left ventricular function.Infusion Reactions, Pulmonary ToxicityAdministration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt trastuzumab-qyyp infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue trastuzumab-qyyp for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.Embryo-Fetal ToxicityExposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception .