zolbetuximab

　　【Indications】

　　VYLOY is a cell lytic antibody targeting claudin 18.2(CLDN18.2),used in combination with fluorouracil and platinum based chemotherapy for first-line treatment of locally advanced,unresectable,or metastatic human epidermal growth factor receptor 2(HER2)negative adult patients with gastric or gastroesophageal junction adenocarcinoma.

　　Recommended dosage

　　•Administer medication only through intravenous infusion.Do not administer medication through intravenous infusion or rapid drip.

　　The recommended initial dose for VYLOY is 800 mg/m2,followed by 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks

　　Adverse reactions

　　The most common adverse reactions(≥15%)when VYLOY is used in combination with mFOLFOX6 or CAPOX regimens are nausea,vomiting,fatigue,decreased appetite,diarrhea,peripheral sensory neuropathy,abdominal pain,constipation,weight loss,allergic reactions,and fever.

　　The most common laboratory abnormalities(≥15%)when VYLOY is used in combination with mFOLFOX6 or CAPOX regimens are decreased neutrophil count,decreased white blood cell count,decreased albumin,increased creatinine,decreased hemoglobin,increased glucose,decreased lymphocyte count,increased aspartate aminotransferase,decreased platelets,increased alkaline phosphatase,increased alanine aminotransferase,decreased glucose,decreased sodium,increased phosphate,decreased potassium,and decreased magnesium.

　　Pharmacological effects

　　Zolbertuximab clzb is a cytolytic antibody targeting claudin 18.2(CLDN18.2),which can consume CLDN18.2 positive cells through antibody dependent cytotoxicity(ADCC)and complement dependent cytotoxicity(CDC).Compared with using zolbetuximab clzb alone or chemotherapy,the combination of Zolbertuximab clzb and chemotherapy has higher anti-tumor activity in a mouse tumor model expressing CLDN18.2.

　　[Storage]

　　Place the VYLOY vial in its original packaging box and refrigerate at a temperature of 2ºC to 8ºC(36ºF to 46ºF).Do not freeze.Do not shake.