Zolbetuximab-clzb (Vyloy)
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Vyloy · Reconstitution and dilution
- Preparation
- Use sterile water for injection: 5 mL for a 100 mg vial or 15 mL for a 300 mg vial. The reconstituted concentration is 20 mg/mL. Dilute in 0.9% sodium chloride to 5 mg/mL.
- Administration and handling
- Follow the dose-specific infusion-rate instructions and premedication requirements.
Product and source details
Astellas Pharma US, Inc. · BLA761365
Product NDC: 0469-3425, 0469-4425
SPL effective 2026-08-11 | SPL version 5. Checked 2026-11-13.
Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.
Product identifiers and clinical review status
U.S. label preparation available. Full monograph review pending.
Exact formulation, concentration, container, manufacturer, regulatory identifiers, and a reproducible label snapshot have not all been reconciled.
What remains to be completed
- Obtain independent corroboration of the label preparation where available.
- Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
- Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.