Do not administer as an intravenous push or bolus. Do not mix Travaris with other drugs.

None

Cardiomyopathy: Trastuzumab can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Trastuzumab can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). Cardiac Monitoring: Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended - þ Baseline LVEF measurement immediately prior to initiation of Trastuzumab þ LVEF measurements every 3 months during and upon completion of Trastuzumab þ Repeat LVEF measurement at 4 weeks intervals if Trastuzumab is withheld for significant left ventricular cardiac dysfunction. þ LVEF measurements every 6 months for at least 2 years following completion of Trastuzumab as a component of adjuvant therapy. Infusion Reactions: Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia. Embryo-Fetal Toxicity: Trastuzumab can cause fetal harm when administered to a pregnant woman. In post-marketing reports, use of Trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Pulmonary Toxicity: Trastuzumab use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Exacerbation of Chemotherapy-Induced Neutropenia: In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving Trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone.

Adjuvant Breast Cancer • Most common adverse reactions (≥5%) are headache, diarrhea, nausea, and chills. Metastatic Breast Cancer • Most common adverse reactions (≥10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. Metastatic Gastric Cancer • Most common adverse reactions (≥10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation and nasopharyngitis.

Patients who receive anthracycline after stopping Trastuzumab may be at increased risk of cardiac dysfunction because of Trastuzumab’s long washout period. If possible, anthracycline-based therapy should be avoided for up to 7 months after stopping Trastuzumab. If anthracyclines are used, the patient’s cardiac function should be monitored carefully.

Pregnancy: Trastuzumab can cause fetal harm when administered to a pregnant woman. It causes oligohydramnios in pregnant women. Women should be tested for pregnancy status before receiving Trastuzumab. If a patient becomes pregnant while receiving Trastuzumab or within 7 months following the last dose of Trastuzumab, patients should immediately seek health care providers or a physician. Nursing mothers: There is no information regarding the presence of Trastuzumab in human milk, the effects on the breastfed infant, or the effects on milk production. Pediatric use: The safety and effectiveness of Trastuzumab in pediatric patients have not been established. Geriatric use: The risk of cardiac dysfunction may increase in geriatric patients as compared to younger patients in those receiving Trastuzumab for metastatic disease.

Travaris Injection: Each combipack contains one vial Travaris (Trastuzumab 440 mg as Lyophilized Powder), one vial Hysol (diluent containing 20 ml Bacteriostatic Water for Injection USP with Benzyl Alcohol BP 1.1%), one IV infusion set (with butterfly needle), one alcohol pad, one first aid bandage and one disposable syringe (10 ml).