Efgartigimod alfa-fcab (Vyvgart)
Dilution requiredFull monograph review pending
U.S. label preparation
Vyvgart · Dilution required
- Preparation
- Use the IV vial (20 mg/mL). Bring the prescribed dose to a total of 125 mL with 0.9% sodium chloride.
- Administration and handling
- Infuse over 1 hour through a 0.2-micron filter. Vyvgart Hytrulo has separate subcutaneous instructions.
Product and source details
argenx US · BLA761195
Product NDC: 73475-3041
SPL effective 2026-05-13 | SPL version 15. 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.