1. Indications and Usage
\nGastric Cancer:
\nIndicated for the treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors are positive for claudin (CLDN) 18.2, as detected by an FDA-approved test, in combination with fluoropyrimidine- and platinum-containing chemotherapy.
\n2. Dosage and Administration
\nPatient Selection:
\nSelect patients whose tumors are CLDN18.2 positive (defined as \u226575% of tumor cells showing moderate-to-strong membranous CLDN18 immunohistochemical staining) using an FDA-approved test.
\nPre-medication:
\nAdminister a combination of antiemetics (e.g., NK-1 receptor antagonist and\/or 5-HT3 receptor antagonist, plus dexamethasone) before each zolbetuximab infusion to prevent nausea and vomiting.
\nRecommended Dosage:
\nRegimen A (Every 3 Weeks): Initial dose of 800 mg\/m\u00b2 (Cycle 1, Day 1), followed by 600 mg\/m\u00b2 every 3 weeks.
\nRegimen B (Every 2 Weeks): Initial dose of 800 mg\/m\u00b2 (Cycle 1, Day 1), followed by 400 mg\/m\u00b2 every 2 weeks.
\nAdministration: Administer via intravenous infusion over 90 minutes (first infusion) or 60 minutes (subsequent infusions). Do not administer as an intravenous push or bolus.
\n3. Mechanism of Action
\nCLDN18.2 Targeting:
\nZolbetuximab is a chimeric (mouse\/human) IgG1 monoclonal antibody that binds to the extracellular domains of CLDN18.2.
\nPhysiological Effect:
\nIt induces CLDN18.2-positive cell depletion through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), leading to tumor cell lysis.
\n4. Safety and Warnings
\nInfusion-Related Reactions (IRR):
\nSevere and fatal IRRs have been reported. Monitor patients closely during and for at least 1 hour after infusion. Interrupt infusion for Grade 2 reactions; permanently discontinue for Grade 3\/4 reactions.
\nSevere Nausea and Vomiting:
\nZolbetuximab has a significant emetogenic potential, particularly during the first cycle of treatment.
\n5. Adverse Reactions
\nMost Common (\u226515%):
\nNausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, weight loss, hypersensitivity, and pyrexia.
\nLaboratory Abnormalities:
\nNeutrophil count decreased, leukocyte count decreased, albumin decreased, creatinine increased, hemoglobin decreased, and lymphocyte count decreased.
\n6. Drug Interactions
\nChemotherapy Agents:
\nWhen used in combination with platinum or fluoropyrimidine-based chemotherapy, monitor for overlapping toxicities (e.g., myelosuppression, gastrointestinal toxicity).
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Zolbetuximab-clzb.
\nStorage:
\nStore at 2\u00b0C to 8\u00b0C (36\u00b0F to 46\u00b0F). Do not freeze or shake vigorously.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u5a01\u7edc\u76ca \u00ae(Vyloy \u00ae)
\nGeneric Name: Zolbetuximab
\nStrength: 100mg per vial, 1 vial per box
\nManufacturer: Baxter Oncology GmbH
\nMarketing Authorization Holder: Astellas Pharma Europe B.V.
\nApproval Date in China: December 31, 2024
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 SJ20240050
\nStorage: Store at 2\u2103\uff5e8\u2103, protect from light, do not freeze, keep out of reach of children<\/p>\n
Price&Cost:Contact Us now for the best price of Zolbetuximab(Vyloy )<\/p>\n","protected":false},"featured_media":3327,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[85],"product_cat":[25],"product_tag":[],"class_list":["post-3326","product","type-product","status-publish","has-post-thumbnail","product_brand-astellas","product_cat-injection","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n