Herceptin 600mg Injection

Herceptin (Trastuzumab) 600mg

Uses
Trastuzumab is used alone or with other medications to treat certain types of breast cancer. It is also used along with other medications to treat certain types of stomach cancer. The types of cancers trastuzumab is used to treat are tumors that produce more than the normal amount of a certain substance called HER2 protein.This medication is called a monoclonal antibody. It works by attaching to the HER2 cancer cells and blocking them from dividing and growing. It may also destroy the cancer cells or signal the body (immune system) to destroy the cancer cells.

Herceptin 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

Herceptin 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) (see section 5.1).

– 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 Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).

Herceptin 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 sections 4.4 and 5.1).

4.2 Posology and method of administration
HER2 testing is mandatory prior to initiation of therapy (see sections 4.4 and 5.1). Herceptin treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only.

It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous fixed dose) is being administered to the patient, as prescribed. Herceptin subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.

Switching treatment between Herceptin intravenous and Herceptin subcutaneous formulations and vice versa, using the three-weekly (q3w) dosing regimen, was investigated in study MO22982 (see section 4.8).

In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is Herceptin (trastuzumab) and not Kadcyla (trastuzumab emtansine).