Garetosmab-grts (Pasatru)
Dilution requiredFull monograph review pending
U.S. label preparation
Pasatru · Dilution required
- Preparation
- Use a bag containing 50-100 mL of 5% dextrose. Target 0.9-25 mg/mL and mix by gentle inversion.
- Administration and handling
- Infuse over 60 minutes and flush with 5% dextrose. Section 2.3 lists acceptable bag and administration-set materials.
- Manufacturer's storage limits
- For the diluted bag, the label permits up to 24 hours at 2-8 C or 16 hours at up to 25 C, measured from preparation to the start of infusion. Do not freeze. A compounding beyond-use date requires a separate assessment.
Product and source details
Regeneron Pharmaceuticals, Inc. · BLA761508
Product NDC: 61755-012
SPL effective 2026-08-14 | 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.