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:

Use in pregnancy & lactation:

Use in Pregnancy: It can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of Trastuzumab. Advise pregnant women and females of reproductive potential that exposure to Trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Trastuzumab.

Use in Lactation: There is no information regarding the presence of Trastuzumab in human milk, the effects on the breastfed infant, or the effects on milk production.

Packing: Each combipack contains 1 vial of Tazumab Injection and 1 vial of Diluent for Tazumab Injection.

Prescribing Description

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