1. Indications and Usage
\nNon-Small Cell Lung Cancer (NSCLC):
\nTreatment of adult patients with unresectable locally advanced or metastatic NSCLC who have HER2(ERBB2) activating mutations and have received at least one prior systemic treatment.
\nNote: This indication was granted under conditional approval based on single-arm clinical trial results.
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Intravenous (IV) Infusion ONLY.
\nRecommended Dosage:
\nStandard Dose: 4.8 mg\/kg.
\nWeight Cap: If patient weight \u226585 kg, fixed dose is 408 mg.
\nFrequency: Administered once every 3 weeks (Q3W).
\nCritical Administration Instructions:
\nPre-medication: Pre-medicate with antiemetics (e.g., dexamethasone, 5-HT3 receptor antagonists) prior to each administration due to emetogenic potential.
\nInfusion Time: Initial infusion over 90 minutes. If tolerated, subsequent infusions may be administered over 30 minutes.
\nPreparation: Reconstitute and dilute by qualified personnel. Do not shake. Do not use Sodium Chloride Injection; use 5% Glucose Injection only. Protect from light.
\nFiltration: Use only 0.20 or 0.22 \u03bcm polyethersulfone (PES) or polysulfone (PS) inline filters.
\n3. Mechanism of Action
\nAntibody-Drug Conjugate (ADC):
\nComposed of a humanized anti-HER2 monoclonal antibody linked to deruxtecan (a topoisomerase I inhibitor).
\nTargeted Delivery:
\nBinds to HER2 on tumor cells, internalized into the cell, and releases the cytotoxic payload, which then inhibits DNA replication and induces cell death. It also exhibits a bystander effect on neighboring HER2-low tumor cells.
\n4. Safety and Warnings
\nInterstitial Lung Disease (ILD)\/Pneumonitis:
\nA serious and potentially fatal adverse reaction. Monitor for signs and symptoms (e.g., dyspnea, cough, fever). Initiate corticosteroids immediately if suspected. Permanently discontinue for Grade 3 or higher.
\nCardiac Dysfunction:
\nRisk of congestive heart failure and left ventricular ejection fraction (LVEF) decline. Assess LVEF prior to initiation and periodically during treatment. Permanently discontinue for symptomatic CHF or significant LVEF drop.
\nHematologic Toxicity:
\nSevere neutropenia, febrile neutropenia, and anemia are common. Monitor blood counts and adjust doses or interrupt treatment as necessary.
\nEmbryo-Fetal Toxicity:
\nCan cause fetal death. Advise females of reproductive potential to use effective contraception.
\n5.Adverse Reactions and Clinical Research
\nMost Common Adverse Reactions:
\nNeutropenia, leukopenia, anemia, thrombocytopenia, nausea, fatigue, anorexia, vomiting, and alopecia.
\nSerious Adverse Events:
\nPlatelet count decrease, anemia, ILD\/pneumonitis, febrile neutropenia, and cardiac dysfunction.
\n6.Drug Interactions
\nCYP450 System:
\nAs a large protein molecule (mAb), it is not expected to interact directly with CYP450 enzymes.
\nLive Vaccines:
\nLive or live-attenuated vaccines should be avoided during treatment.
\n7.Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Trastuzumab Rezetecan.
\nAppearance: White to off-white blocky substance or powder.
\nPackaging: Single-use vial (100 mg).
\nStorage: Store in the original carton at 2\u00b0C to 8\u00b0C. Do not freeze.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name:\u827e\u7ef4\u8fbe \u00ae\uff08Aivida\u00ae\uff09
\nGeneric Name: Trastuzumab Rezetecan
\nStrength: 0.1 g (100 mg) per vial
\nManufacturer: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
\nMarketing Authorization Holder: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
\nApproval Date in China: May 27, 2025
\nRegistration Number: \u56fd\u836f\u51c6\u5b57S20250024
\nStorage: Store and transport at 2\u00b0C\u20138\u00b0C, protected from light; do not freeze. Refer to the full package insert for storage requirements after reconstitution and dilution.<\/p>\n
Price&Cost:Contact Us now for the best price of Trastuzumab Rezetecan\uff08Aivida\uff09<\/p>\n","protected":false},"featured_media":4398,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[25,73],"product_tag":[],"class_list":["post-4397","product","type-product","status-publish","has-post-thumbnail","product_cat-injection","product_cat-chinese-innovative-drug","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n