Golimumab-sldi (Immgolis Intri)
Dilution requiredFull monograph review pending
U.S. label preparation
Immgolis Intri · Dilution required
- Preparation
- Use only the Immgolis Intri IV vial, 50 mg/4 mL. Exchange saline for the prescribed volume of concentrate in a 0.9% sodium chloride bag to a final volume of 100 mL. Immgolis prefilled syringes are subcutaneous.
- Administration and handling
- Infuse over 30 minutes through a sterile, nonpyrogenic, low protein-binding in-line filter of 0.22 micron or smaller. Use a separate line.
- Manufacturer's storage limits
- The diluted infusion may be held at room temperature for up to 4 hours. A compounding beyond-use date requires a separate assessment.
Product and source details
Accord BioPharma / Bio-Thera Solutions · BLA761452
FDA labeling action 2026-05-15. 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.