Composition: Tazumab Injection: Each vial contains Trastuzumab INN 440 mg lyophilized powder for IV infusion.
Diluent for Tazumab Injection: Each vial contains Bacteriostatic Water for Injection 20ml (Benzyl Alcohol USP 1.1%).
Adjuvant Breast Cancer: Trastuzumab is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative ER/PR negative or with one high risk feature breast cancer
• as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
• as part of a treatment regimen with docetaxel and carboplatin
• as a single agent following multi-modality anthracycline based therapy
Metastatic Breast Cancer: Trastuzumab is indicated:
• In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
• As a single agent for treatment of HER2-overexpressing breast cancer in patient who have received one or more chemotherapy regimens for metastatic disease. overexpressing breast cancer in patient
Metastatic Gastric Cancer: Trastuzumab is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Dosage and Administration:
Recommended Doses and Schedules: Do not administer as an intravenous push or bolus. Do not mix Trastuzumab with other drugs.
Adjuvant Treatment, Breast Cancer: Administer according to one of the following doses and schedules for a total of 52 weeks of Trastuzumab therapy: