Before taking Vyloy(zolbetuximab)

Zolbetuximab is mainly indicated for the treatment of CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ) cancer. The following are the precautions for zolbetuximab.

Precautions for Zolbetuximab

Zolbetuximab should be reconstituted with 5.0 mL of Water for Injection as specified in the Japanese Pharmacopoeia, resulting in a drug concentration of 20 mg/mL after reconstitution. Aseptic conditions must be maintained during reconstitution: the solvent should be slowly injected along the inner wall of the zolbetuximab vial, without shaking; instead, gently swirl until the drug is completely dissolved.

After reconstitution, allow the vial to stand to let air bubbles dissipate. Avoid direct sunlight throughout the preparation process. The reconstituted solution should be a clear liquid ranging from colorless to slightly yellow. Withdraw the required volume from the vial and add it to a normal saline infusion bag to achieve a diluted concentration of 2.0 mg/mL. Gently invert the infusion bag to mix the solution (to prevent foaming), and avoid direct sunlight during the entire process. Visually inspect the diluted solution for particulate matter—do not use the solution if particulates are present.

The diluted drug should be used promptly: if stored at room temperature, administration must be completed within 6 hours. If storage of the diluted drug is necessary, it should be stored at 2-8°C and used as soon as possible within 24 hours after dilution. Any unused residual solution should be discarded promptly. Do not administer zolbetuximab through the same infusion line simultaneously with other drugs.