Guselkumab (Tremfya)
Dilution requiredFull monograph review pending
U.S. label preparation
Tremfya · Dilution required
- Preparation
- For the 200 mg IV dose, remove 20 mL from a 250 mL bag of 0.9% sodium chloride and replace with 20 mL from the 200 mg/20 mL IV vial. Final concentration is 0.8 mg/mL.
- Administration and handling
- Gently mix. Infuse over at least 1 hour through a sterile, low protein-binding 0.2 micron in-line filter. Use a separate line.
Product and source details
Janssen Biotech, Inc. · BLA761061
Product NDC: 57894-650
SPL effective 2026-10-20 | SPL version 30. 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.