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Common Name: Trastuzumab for Injection
Trade Name: Herceptin
Full Names: Herceptin, Trastuzumab for Injection, Trastuzumab, Herceptin, Trastuzumab
Indications:
Metastatic breast cancer:
This product is suitable for HER2 Overexpressed metastatic breast cancer: as a single agent for metastatic breast cancer who have received one or more chemotherapy regimens; in combination with paclitaxel or docetaxel for patients with metastatic breast cancer who have not received chemotherapy.
Adjuvant treatment of breast cancer:
This product as a single agent is suitable for the adjuvant treatment of HER2-overexpressing breast cancer after surgery, adjuvant chemotherapy containing anthracycline antibiotics, and radiotherapy (if applicable).
Metastatic gastric cancer:
This product combined with capecitabine or 5-fluorouracil and cisplatin is suitable for patients with HER2-overexpressing metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received previous treatment for metastatic disease.
Trastuzumab can only be used in patients with metastatic gastric cancer who overexpress HER2, defined as IHC3+ or IHC2+/FISH+ results using a validated detection method.
Usage and dosage:
This product should be administered by intravenous infusion.
Metastatic breast cancer:
Initial loading dose: The recommended initial loading dose of this product is 4 mg/kg. Intravenous infusion over 90 minutes. Patients should be observed for fever, chills, or other infusion-related symptoms. These symptoms can be controlled by stopping the infusion, and the infusion can be continued after the symptoms disappear.
Maintenance dose: The recommended weekly dosage of this product is 2mg/kg. If the initial loading dose is tolerated, this dose can be infused intravenously over 30 minutes. Treatment is maintained until disease progression.
Adjuvant therapy for breast cancer:
Initiate trastuzumab therapy after completion of all chemotherapy. The dosing regimen of trastuzumab is: an initial loading dose of 8 mg/kg followed by a maintenance dose of 6 mg/kg every 3 weeks as an intravenous infusion over approximately 90 minutes. A total of 17 doses were used (52 weeks of treatment).
Metastatic gastric cancer:
A dosing schedule every three weeks is recommended, with an initial loading dose of 8 mg/kg, followed by 6 mg/kg every three weeks. The first infusion time is approximately 90 minutes. If the patient tolerates the initial infusion well, subsequent infusions can be changed to 30 minutes. Treatment is maintained until disease progression.
Adverse reactions:
The most common adverse reactions are: fever, nausea, vomiting, infusion reactions, diarrhea, infection, worsening of cough, headache, fatigue, dyspnea, rash, neutropenia, anemia and myalgia.
Adverse reactions requiring interruption or discontinuation of trastuzumab therapy include: congestive heart failure, significant decrease in left ventricular function, serious infusion reactions, and pulmonary toxicity.
When used in the treatment of gastric cancer, the most common adverse reactions are: neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infection, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis and dysgeusia. In addition to disease progression, the most common adverse reactions leading to treatment discontinuation were infection, diarrhea, and febrile neutropenia.
Contraindications:
Contraindicated in patients with known hypersensitivity to trastuzumab or to any other component of this product.
This product uses benzyl alcohol as a solvent and is prohibited for intramuscular injection in children.
Precautions:
Cardiotoxicity: Trastuzumab can cause left ventricular dysfunction, arrhythmia, hypertension, symptomatic heart failure, cardiomyopathy, and cardiac death, and can also cause symptomatic reduction in left ventricular ejection fraction (LVEF).
Infusion reactions: Infusion reactions include a range of symptoms, including fever, chills, and occasionally nausea, vomiting, pain (in some cases at the tumor site), headache, dizziness, dyspnea, hypotension, rash, and weakness.
Embryotoxicity: Trastuzumab used by pregnant women can cause harm to the fetus. In post-marketing reports, trastuzumab use during pregnancy has been associated with oligohydramnios and subsequent pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Patients should be informed that trastuzumab use during pregnancy may cause harm to the fetus, and contraceptive counseling services should be provided to patients of childbearing potential.
Pulmonary Toxicity: Serious pulmonary toxicity events have been reported with postmarketing clinical use of trastuzumab, and these events have occasionally resulted in death. Additionally, cases have been reported of interstitial lung disease (including pulmonary infiltrates), acute respiratory distress syndrome, pneumonia, noninfectious pneumonia, pleural effusion, respiratory distress, acute pulmonary edema, and functional insufficiency. These adverse events may occur as part of an infusion reaction or may occur delayed. Patients with preexisting symptomatic lung disease or tumors involving the lungs who have dyspnea at rest may have a more severe reaction. Risk factors for interstitial lung disease include prior or concomitant use of other antineoplastic therapies known to cause interstitial lung disease, such as taxanes, gemcitabine, vinorelbine, and radiation therapy. These events may be part of an infusion-related reaction or may be delayed in onset. Patients who develop dyspnea at rest due to complications of advanced malignancy and comorbidities may be at high risk for pulmonary events. Therefore, these patients should not receive trastuzumab.
Exacerbation of Chemotherapy-Induced Neutropenia: In a randomized, controlled clinical trial of trastuzumab plus chemotherapy for the treatment of metastatic breast cancer, the incidence of NCI CTC grade 3 to 4 neutropenia and febrile neutropenia was higher in the combined myelosuppressive chemotherapy group than in the chemotherapy alone group. The incidence of death from sepsis was not significantly higher.
HER2 Testing: Detection of HER2 protein overexpression is necessary to screen patients suitable for trastuzumab treatment because only patients with HER2 overexpression have been shown to benefit from treatment. Testing for HER2 overexpression and HER2 gene amplification should be performed by a laboratory certified to be proficient in this specific technology. Incorrect procedures, including using tissue of suboptimal fixation standards, not applying specific reagents, deviating from specific technical guidelines, and failing to include appropriate experimental controls, may lead to unreliable results.
Storage:
Store and transport in the dark at 2 to 8°C. This product can be stored stably for 28 days at 2-8°C after being dissolved in the diluent provided. The prepared solution contains preservatives so it can be used multiple times. Any remaining solution after 28 days should be discarded.
Do not freeze the prepared solution.
Mechanism of action:
Trastuzumab is a recombinant DNA-derived humanized monoclonal antibody that specifically acts on the extracellular site of human epidermal growth factor receptor-2 (HER2). This antibody contains a human IgG1 framework and the complementarity determining region is derived from a mouse anti-p185 HER2 antibody and is capable of binding to HER2.
Trastuzumab has been shown to inhibit the proliferation of HER2-overexpressing tumor cells in vitro and in animal experiments. In addition, trastuzumab is a potential mediator of antibody-dependent cell-mediated cytotoxicity (ADCC). In in vitro studies, trastuzumab-mediated ADCC was shown to occur preferentially in HER2-overexpressing cancer cells compared with HER2 non-overexpressing cancer cells.