Pegzilarginase-nbln (Loargys)
Dilution requiredFull monograph review pending
U.S. label preparation
Loargys · Dilution required
- Preparation
- For IV use, dilute the calculated drug volume with 0.9% sodium chloride to a maximum of 0.5 mg/mL.
- Administration and handling
- Infuse the IV preparation over at least 30 minutes. The subcutaneous preparation uses the undiluted solution.
- Manufacturer's storage limits
- Use promptly. For a prepared IV container, the label allows up to 2 hours at 20-25 C or 4 hours at 2-8 C. These limits include the entire infusion. A compounding beyond-use date requires a separate assessment.
Product and source details
Immedica Pharma US Inc. · BLA761211
Product NDC: 81583-102, 81583-105
SPL effective 2026-02-23 | SPL version 1. 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.