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Vyloy (zolbetuximab-clzb)
zolbetuximab
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: nonproprietary name = zolbetuximab-clzb
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, and dosing incl. toxicity-related dose adjustments
CLDN18.2-positive HER2-negative gastric CA, locally advanced unresectable or metastatic
- [800 mg/m^2/dose IV x1, then 600 mg/m^2/dose IV q3wk]
- Alt: 800 mg/m^2/dose IV x1, then 400 mg/m^2/dose IV q2wk; Info: for pts w/ gastric or gastroesophageal junction adenocarcinoma; part of multi-drug chemo regimen
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x8mo after D/C
Drug Interactions .
Overview
zolbetuximab
cytolytic antibody
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- anaphylaxis
- infusion rxn, severe
- hypersensitivity rxn
- nausea, severe
- vomiting, severe
Common Reactions
- nausea
- vomiting
- appetite decr.
- hypersensitivity rxn
- neutropenia
- weight decr.
- peripheral edema
- infusion rxn
- albumin decr.
- neutrophils decr.
- glucose decr.
- leukocytes decr.
- potassium decr.
Safety/Monitoring .
Monitoring Parameters
s/sx infusion rxn during and for at least 2h after infusion
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of embryo-fetal toxicity based on animal data up to 1.9x systemic exposure and drug's mechanism of action
Lactation
Clinical Summary
avoid breastfeeding during tx and x8mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: catabolism; CYP450: unknown
Excretion: other; Half-life: unknown
Subclass: Immunotherapy, Claudin 18.2 (CLDN18.2) Inhibitors
Mechanism of Action
binds to claudin (CLDN) 18.2-positive cells, inducing cell death via antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC)
Formulary .
No Formulary Selected
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