ADAMTS13, recombinant-krhn (Adzynma)
Reconstitution onlyFull monograph review pending
U.S. label preparation
Adzynma · Reconstitution only
- Preparation
- Reconstitute each vial with its supplied 5 mL of sterile water using the BAXJECT II Hi-Flow device. Use the actual vial potency to calculate the dose volume.
- Administration and handling
- Administer IV at 2 to 4 mL/min. Use a separate device for each vial. The updated U.S. label carries a boxed warning for neutralizing antibodies to ADAMTS13, with serious outcomes including death.
- Manufacturer's storage limits
- Use within 3 hours of reconstitution at room temperature, up to 30 degrees C. A compounding beyond-use date requires a separate assessment.
- Safety update
- FDA boxed warning update, September 2026 (opens in a new tab)
Product and source details
TAKEDA PHARMACEUTICALS AMERICA, INC. · BLA125795
Product NDC: 64764-140, 64764-145
SPL effective 2026-10-30 | SPL version 10. 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.