Datopotamab deruxtecan-dlnk (Datroway)
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Datroway · Reconstitution and dilution
- Preparation
- Add 5 mL sterile water for injection to each 100 mg vial (20 mg/mL). Transfer the calculated dose to a bag containing 100 mL of 5% dextrose.
- Administration and handling
- Use the filter, light protection and infusion rate in section 2.5.
Product and source details
Daiichi Sankyo Inc. · BLA761394
Product NDC: 65597-801
SPL effective 2026-05-27 | SPL version 18. 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.