Formulation and Specifications: Injection: 440 mg (20 ml)/vial
Indications: This product in combination with capecitabine or fluorouracil and cisplatin is indicated for patients with HER2-positive metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received prior therapy against metastatic disease, and for patients with HER2-positive metastatic gastric cancer who have progressed on cisplatin and fluorouracil-based therapy and have not used trastuzumab, trastuzumab may be considered in combination with other effective chemotherapeutic agents; trastuzumab should only be used in patients with HER2-positive metastatic gastric cancer, defined as an IHC3+ or IHC2+/FISH+ result obtained using a validated assay.
Key points for rational drug use:
1. HER2 testing should be performed prior to treatment with this product, and the relevant test should be performed using a test method approved by the State Drug Administration.
The left ventricular ejection fraction (LVEF) should be measured before starting trastuzumab therapy and LVEF should be monitored closely during treatment. ～Trastuzumab may be resumed if LVEF returns to the normal range or if there is an absolute decrease of ≤15% from pre-treatment values within 4 to 8 weeks. trastuzumab should be discontinued permanently if LVEF continues to decrease (>8 weeks) or if trastuzumab therapy is discontinued more than three times due to cardiotoxicity.
3. Trastuzumab treatment should be interrupted or discontinued when patients develop congestive heart failure, significantly decreased left ventricular function, severe infusion reactions and pulmonary reactions during gastric cancer treatment.