Teplizumab-mzwv (Tzield)
Dilution requiredFull monograph review pending
U.S. label preparation
Tzield · Dilution required
- Preparation
- First prepare a 100 mcg/mL intermediate by adding 2 mL of drug to 18 mL of 0.9% sodium chloride. Then prepare the final infusion for the day's prescribed dose.
- Administration and handling
- The intermediate requires a second preparation step. Follow the bag or syringe instructions, material restrictions and age-specific infusion time.
Product and source details
Provention Bio, Inc. · BLA761183
Product NDC: 73650-316
SPL effective 2026-08-14 | SPL version 11. 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.