Herceptin 600 mg solution for injection in vial
One vial of 5 mL contains 600 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
For the full list of excipients, see section 6.1.
Solution for injection
Clear to opalescent solution, colourless to yellowish.
Breast cancer
Metastatic breast cancer
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).
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 formulation 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).
Posology
The recommended dose for Herceptin subcutaneous formulation is 600 mg irrespective of the patient's body weight. No loading dose is required. This dose should be administered subcutaneously over 2-5 minutes every three weeks.
In the pivotal trial (BO22227) Herceptin subcutaneous formulation was administered in the neoadjuvant/adjuvant setting in patients with early breast cancer. The preoperative chemotherapy regimen consisted of docetaxel (75 mg/m2) followed by FEC (5FU, epirubicin and cyclophosphamide) at a standard dose.
See section 5.1 for chemotherapy combination dosing.
Duration of treatment
Patients with MBC should be treated with Herceptin until progression of disease. Patients with EBC should be treated with Herceptin for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Dose reduction
No reductions in the dose of Herceptin were made during clinical trials. Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time. Refer to the Summary of Product Characteristics (SmPC) for pacli
