Tarlatamab-dlle (Imdelltra)
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Imdelltra · Reconstitution and dilution
- Preparation
- Reconstitute the 1 mg vial with 1.3 mL sterile water for injection or the 10 mg vial with 4.4 mL. The resulting concentrations differ. Use the matching row in Tables 8-11.
- Administration and handling
- Prepare the 250 mL saline bag as directed, including 13 mL of the supplied IV solution stabilizer before adding drug. The stabilizer cannot replace sterile water in the vial.
Product and source details
Amgen, Inc · BLA761344
Product NDC: 55513-059, 55513-077
SPL effective 2026-09-11 | SPL version 8. 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.