Omidubicel-onlv (Omisirge)
Dilution requiredFull monograph review pending
U.S. label preparation
Omisirge · Dilution required
- Preparation
- For transplant centers. Confirm patient and unit identity. Thaw each fraction and dilute it only with its matched infusion-solution bag. For the cultured fraction add approximately 20 mL, swirl, then add the remaining approximately 60 mL. For the noncultured fraction the corresponding volumes are approximately 10 and 30 mL.
- Administration and handling
- Infuse the cultured fraction first and complete it within 2 hours of dilution. Start the noncultured fraction within 1 hour of completing the first infusion and finish it within 1 hour of its own dilution. Do not use a leukodepleting filter. Follow the complete preparation instructions for thawing and integrity checks.
Product and source details
Gamida Cell Inc. · BLA125738
Product NDC: 73441-800
SPL effective 2026-02-19 | SPL version 8. 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.