Tazumab

Trastuzumab INN

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%).

Indications:

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:

Prescribing Description

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