Rebisufligene etisparvovec-hopf (Fayuvi)
No admixture requiredFull monograph review pending
U.S. label preparation
Fayuvi · No admixture required
- Preparation
- Specialist gene-therapy preparation without an admixture bag. Use the weight-band table to select vials. Thaw at room temperature and draw the prescribed volume into polypropylene syringes. Prepare all syringes before starting.
- Administration and handling
- Place a 0.2 micron in-line filter between syringe and tubing, prime with Fayuvi, and use the label-specified syringe pump, premedication and monitoring.
Product and source details
Ultragenyx Pharmaceutical Inc. · BLA125845
SPL effective 2026-10-01 | 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.