Pafolacianine (Cytalux)
Dilution requiredFull monograph review pending
U.S. label preparation
Cytalux · Dilution required
- Preparation
- Thaw the vial as directed. Add the calculated dose to a 250 mL bag of 5% dextrose. Use only 5% dextrose for dilution.
- Administration and handling
- Protect the bag from light during storage and infusion. The interval between infusion and imaging depends on the procedure.
Product and source details
On Target Laboratories, Inc. · NDA214907
Product NDC: 81052-138
SPL effective 2026-04-01 | SPL version 10. 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.