Zanidatamab-hrii (Ziihera)
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Ziihera · Reconstitution and dilution
- Preparation
- Reconstitute a 300 mg vial with 5.7 mL sterile water for injection (50 mg/mL). Further dilute in 0.9% sodium chloride or 5% dextrose to 4-20 mg/mL.
- Administration and handling
- Use the smallest suitable diluent volume. The label caps volume at 500 mL.
Product and source details
Jazz Pharmaceuticals, Inc. · BLA761416
Product NDC: 68727-950
SPL effective 2026-08-24 | SPL version 3. 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.