Penpulimab-kcqx
Dilution requiredFull monograph review pending
U.S. label preparation
penpulimab-kcqx · Dilution required
- Preparation
- Withdraw the prescribed amount and add to a bag containing no more than 100 mL of 0.9% sodium chloride. Aim for 2-5 mg/mL.
- Administration and handling
- Infuse over 60 minutes. The label limits the interval from dilution through the end of infusion to 4 hours.
Product and source details
Akeso Biopharma Co., Ltd. · BLA761258
Product NDC: 83654-105
FDA submission action 2026-08-31. 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.