Remestemcel-L-rknd (Ryoncil)
Dilution requiredFull monograph review pending
U.S. label preparation
Ryoncil · Dilution required
- Preparation
- For cell-therapy services. In a biological safety cabinet, follow the specified thawing procedure and transfer the patient-specific volume of cells to the infusion bag. Slowly add 40 mL of Plasma-Lyte A and mix gently.
- Administration and handling
- Use an infusion pump and 40 to 260 micron blood filter. Below 35 kg, infuse over 60 minutes. At 35 kg or more, do not exceed 6 mL/min. Infusion must occur within 5 hours of starting to thaw the first vials.
Product and source details
Mesoblast · BLA125706
Product NDC: 73648-111, 73648-112, 73648-113, 73648-114, 73648-115, 73648-116, 73648-117, 73648-118, 73648-119, 73648-120, 73648-121, 73648-122
SPL effective 2025-09-11 | SPL version 5. 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.