Fam-trastuzumab deruxtecan-nxki (Enhertu)
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Enhertu · Reconstitution and dilution
- Preparation
- Add 5 mL sterile water for injection to a 100 mg vial to obtain 20 mg/mL. Add the prescribed volume to a bag containing 100 mL of 5% dextrose. Sodium chloride can cause particles to form.
- Administration and handling
- Protect the infusion bag from light. Infuse the first dose over 90 minutes. Subsequent doses may run over 30 minutes if prior infusions were well tolerated. Use the filter specified in the label.
Product and source details
Daiichi Sankyo Inc. · BLA761139
Product NDC: 65597-406
SPL effective 2026-05-15 | SPL version 28. 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.