Avalglucosidase alfa-ngpt (Nexviazyme)
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Nexviazyme · Reconstitution and dilution
- Preparation
- Use 10 mL sterile water for injection per 100 mg vial. Dilute in 5% dextrose to 0.5-4 mg/mL.
- Administration and handling
- Use the weight- and dose-specific total volume in Table 1 and the rate schedule in section 2.6.
Product and source details
Genzyme Corporation · BLA761194
Product NDC: 58468-0426
SPL effective 2025-06-05 | SPL version 4. 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.