Efanesoctocog alfa (Altuviiio)
Reconstitution onlyFull monograph review pending
U.S. label preparation
Altuviiio · Reconstitution only
- Preparation
- Use only the supplied prefilled sterile-water syringe and vial adapter. Transfer all diluent to the vial and swirl gently. Use the actual potency on the label to calculate the volume.
- Administration and handling
- Inject the reconstituted dose over 1 to 10 minutes, according to patient comfort.
- Manufacturer's storage limits
- Use as soon as possible and within 3 hours of reconstitution. A compounding beyond-use date requires a separate assessment.
Product and source details
Bioverativ Therapeutics Inc. · BLA125771
Product NDC: 71104-978, 71104-979, 71104-981, 71104-982, 71104-983, 71104-984
SPL effective 2026-10-20 | SPL version 11. 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.