Formulation and specifications: Injection: 440mg (20ml)/bottle
Indications:
1. Recurrent metastatic breast cancer: This product is indicated for HER2-positive metastatic breast cancer. It is used alone for metastatic breast cancer that has received multiple chemotherapy regimens; in combination with chemotherapy drugs such as paclitaxel or docetaxel, it is used for patients with metastatic breast cancer who have not received chemotherapy.
2. Adjuvant treatment for breast cancer: It is indicated for the adjuvant treatment of HER2-positive operable breast cancer with tumor diameter >0.5cm; for invasive breast cancer with tumor diameter <0.5cm, it is necessary to consider whether to use it in combination with other factors. Trastuzumab is generally not used in combination with anthracyclines, but can be used sequentially; it can be combined with paclitaxel and other (cyclophosphamide, carboplatin, etc.) chemotherapy drugs, and can also be used simultaneously with radiotherapy and adjuvant endocrine therapy.
3. neoadjuvant treatment for breast cancer: neoadjuvant treatment in combination with chemotherapy, followed by adjuvant therapy, for locally advanced (including inflammatory) HER2-positive breast cancer. The total course of trastuzumab is continued for 1 year after surgery.
Key points for rational drug use:
1. Before receiving trastuzumab treatment, HER2 testing should be performed in a qualified pathology laboratory, and only HER2-positive patients should be treated with trastuzumab.
2. Concurrent application with anthracyclines should be used with caution, as it may increase cardiotoxicity and heart failure may occur in severe cases, and sequential use or separate use is recommended.
In clinical practice, trastuzumab should be started after baseline assessment of past history, physical examination, electrocardiogram, and echocardiogram LVEF, and LVEF should be monitored every 3 months during use, and more frequently if the patient has asymptomatic cardiac insufficiency. Trastuzumab should be permanently discontinued if LVEF is <50% or more than 16% below pre-treatment and should be followed until it returns to more than 50%.
4. Several clinical studies have confirmed that combining trastuzumab with other chemotherapeutic agents or endocrine agents in patients with HER2-positive metastatic breast cancer may further increase the clinical benefit.
5. Evidence also confirms the clinical benefit of continuing trastuzumab in HER2-positive breast cancer that has progressed after trastuzumab treatment.
6. Weekly dosing regimen Initial loading dose: The recommended initial loading dose of this product is 4 mg/kg. infused intravenously over 90 minutes. Maintenance dose: The recommended weekly dose of trastuzumab is 2 mg/kg. if the initial loading dose is tolerated, then this dose may be administered intravenously over 30 minutes. the initial loading dose of the 3-week dosing regimen is 8 mg/kg, followed by 6 mg/kg every three weeks. The infusion time is approximately 90 minutes for repeated 6 mg/kg tri-weekly dosing. If the patient tolerates the initial infusion well, subsequent infusions may be changed to 30 minutes. The configured solution is diluted in 250 ml of 0.9% NaCl. 5% glucose (which can cause protein aggregation) should not be used.
7. Duration of treatment: The duration of adjuvant therapy with trastuzumab for breast cancer patients after surgery is 1 year, and no extension of treatment is recommended.