Complete dosing information for ZOLBETUXIMAB
Medical guidance required: Dosing information here is for educational purposes. Your healthcare provider will determine the appropriate dose based on your specific condition, kidney function, other medications, and medical history. Never adjust your dose without consulting your doctor or pharmacist.
2 DOSAGE AND ADMINISTRATION • Administer by intravenous infusion only . Do not administer VYLOY as an intravenous push or bolus. ( 2.6 ) • The recommended first dose of VYLOY is 800 mg/m 2 followed by 600 mg/m 2 every 3 weeks or 400 mg/m 2 every 2 weeks. ( 2.3 ) 2.1 Patient Selection Select adult patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors are CLDN18.2 positive (defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining) for treatment with VYLOY in combination with fluoropyrimidine- and platinum-containing chemotherapy using an FDA-approved test [see Clinical Studies ( 14 )]. Information on FDA-approved tests for the detection of CLDN18.2 is available at https://www.fda.gov/CompanionDiagnostics . 2.2 Prior to Administration If a patient is experiencing nausea and/or vomiting prior to administration of VYLOY, the symptoms should be resolved to Grade ≤1 before admini