Cosibelimab-ipdl (Unloxcyt)
Dilution requiredFull monograph review pending
U.S. label preparation
Unloxcyt · Dilution required
- Preparation
- For the labeled 1,200 mg preparation, add 20 mL of drug to a 250 mL bag containing 0.9% sodium chloride.
- Administration and handling
- Administer over 60 minutes with a sterile 0.2- to 0.22-micron filter.
Product and source details
Sun Pharmaceutical Industries, Inc. · BLA761297
Product NDC: 70095-130
SPL effective 2026-09-21 | 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.