Linvoseltamab-gcpt (Lynozyfic)
Dilution requiredFull monograph review pending
U.S. label preparation
Lynozyfic · Dilution required
- Preparation
- Use a PVC or polyolefin bag of 0.9% sodium chloride. Select the vial presentation, withdrawal volume and bag size for the prescribed dose in Table 6.
- Administration and handling
- The step-up and full-dose vials have different concentrations. Use the labeled line and flush instructions.
Product and source details
Regeneron Pharmaceuticals, Inc. · BLA761400
Product NDC: 61755-054, 61755-056
SPL effective 2025-07-02 | SPL version 6. 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.