Casimersen (Amondys 45)
Dilution requiredFull monograph review pending
U.S. label preparation
Amondys 45 · Dilution required
- Preparation
- Bring the dose to a final volume of 100-150 mL with 0.9% sodium chloride.
- Administration and handling
- Infuse over 35-60 minutes with a 0.2-micron in-line filter.
Product and source details
Sarepta Therapeutics, Inc. · NDA213026
Product NDC: 60923-227
SPL effective 2026-01-09 | 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.