Piflufolastat F 18 (Pylarify)
Optional dilutionFull monograph review pending
U.S. label preparation
Pylarify · Optional dilution
- Preparation
- For the Pylarify presentation, dilution with 0.9% sodium chloride is optional. Determine the administered volume from activity and calibration time.
- Administration and handling
- Radiopharmacy preparation. Assay the activity before administration and follow the full radiation-safety instructions.
Product and source details
Progenics Pharmaceuticals, Inc. · NDA214793
Product NDC: 71258-022
SPL effective 2026-02-18 | 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.