Zolbetuximab-clzb is a chimeric (mouse/human) antibody composed of variable regions derived from mouse anti-human claudin-18 isoform 2 monoclonal antibody and constant regions derived from human IgG1. The molecular weight is approximately 147 kDa. VYLOY (zolbetuximab-clzb) for injection is provided as a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials for intravenous use. VYLOY is supplied as 100 mg per vial and requires reconstitution with Sterile Water for Injection, USP, (5 mL) resulting in a clear to slightly opalescent, colorless to slightly yellow solution Reference ID: 5464272
with a final concentration of 20 mg/mL. Each mL of reconstituted solution contains 20 mg of zolbetuximab-clzb, arginine (23.24 mg), polysorbate 80 (0.21 mg), sucrose (51.30 mg), and phosphoric acid to adjust pH to 6.0.
VYLOY (zolbetuximab-clzb) Injection - 100 mg lyophilized powder in a single-dose vial.
The recommended first dose of VYLOY is 800 mg/m2 followed by 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks.
VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated incombination with fluoropyrimidine- and platinum-containing chemotherapyfor the first-line treatment of adults with locally advanced unresectable or
metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin(CLDN) 18.2 positive as determined by an FDA-approved test.