Gedatolisib (Revtorpyk)
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Revtorpyk · Reconstitution and dilution
- Preparation
- Reconstitute with 20 mL sterile water for injection or 5% dextrose. Transfer the dose-specific volume into a bag containing 250 mL of 5% dextrose.
- Administration and handling
- Avoid chloride-containing solutions throughout preparation and administration. Use 5% dextrose for both line flushes.
- Manufacturer's storage limits
- The reconstituted vial may stand for up to 4 hours at 20-25 C. The labeled hold for the diluted infusion solution is up to 24 hours at 20-25 C. Do not refrigerate or freeze the diluted bag. A compounding beyond-use date requires a separate assessment.
| Prescribed dose | Volume to transfer |
|---|---|
| 180 mg | 20 mL |
| 150 mg | 17 mL |
| 130 mg | 14 mL |
Each dose goes into a bag containing 250 mL of 5% dextrose. See section 2.5.
Product and source details
Celcuity Inc. · NDA219908
Product NDC: 84577-751
SPL effective 2026-08-19 | SPL version 2. 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.