Treosulfan (Grafapex)
Reconstitution onlyFull monograph review pending
U.S. label preparation
Grafapex · Reconstitution only
- Preparation
- Use 20 mL per 1 g vial or 100 mL per 5 g vial, for approximately 50 mg/mL. Options in Table 2 include 0.45% or 0.9% sodium chloride, 5% dextrose and sterile water for injection.
- Administration and handling
- Sterile water alone is discouraged in children aged 12 years or younger because of low osmolality. Follow the glass-container and handling instructions.
Product and source details
Medexus Pharma, Inc. · NDA214759
Product NDC: 59137-335, 59137-365
SPL effective 2025-01-31 | SPL version 1. 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.