Glofitamab-gxbm (Columvi)
Dilution requiredFull monograph review pending
U.S. label preparation
Columvi · Dilution required
- Preparation
- For bag infusion use 0.9% or 0.45% sodium chloride to reach 0.1-0.6 mg/mL. Bag material depends on the diluent. See Table 7.
- Administration and handling
- The alternative syringe preparation in section 2.6 applies only to the 2.5 mg dose. Check the step-up and monitoring requirements.
Product and source details
Genentech, Inc. · BLA761309
Product NDC: 50242-127, 50242-125
SPL effective 2026-06-25 | SPL version 9. 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.