Apitegromab-mstn (Isembyld)
Dilution requiredFull monograph review pending
U.S. label preparation
Isembyld · Dilution required
- Preparation
- Dilute the IV vial in 0.9% sodium chloride to 5 mg/mL. Use a dedicated DEHP-free line with a low-protein-binding 0.2- or 0.22-micron PES filter.
- Administration and handling
- Infuse over approximately 60-120 minutes. Do not exceed 150 mL/hour.
- Manufacturer's storage limits
- Use promptly. If held, protect the bag from light. The limit is 4 hours at either 20-25 C or 2-8 C, including preparation and infusion. A compounding beyond-use date requires a separate assessment.
Product and source details
Scholar Rock, Inc. · BLA761463
Product NDC: 84717-150
SPL effective 2026-09-14 | SPL version 3. 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.