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Hertraz

Hertraz Indications/Uses

trastuzumab

Manufacturer:

Biocon Biologics Ltd

Distributor:

Biocon Biologics Phils
Full Prescribing Info
Indications/Uses
Metastatic Breast Cancer: Trastuzumab is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
In combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
In combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
In combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
Early Breast Cancer: Trastuzumab is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).
Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).
Following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
In combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
In combination with neoadjuvant chemotherapy followed by adjuvant Trastuzumab therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see Pharmacology: Pharmacodynamics under Actions and Precautions).
Trastuzumab should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see Pharmacology: Pharmacodynamics under Actions and Precautions).
Metastatic Gastric Cancer: Trastuzumab in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Trastuzumab should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used (see Pharmacology: Pharmacodynamics under Actions and Precautions).
Limitation of Use: Trastuzumab is not recommended for use in children below 18 years of age and pregnant women due to insufficient safety and efficacy data in these populations Breast feeding should be avoided during Trastuzumab therapy.
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