Spesolimab-sbzo (Spevigo)
Dilution requiredFull monograph review pending
U.S. label preparation
Spevigo · Dilution required
- Preparation
- For the 900 mg IV flare treatment, remove 15 mL from a 100 mL bag of 0.9% sodium chloride. Replace it with the contents of two 450 mg/7.5 mL IV vials.
- Administration and handling
- The IV instructions apply to the vials. The maintenance prefilled syringes are for subcutaneous use.
Product and source details
Boehringer Ingelheim Pharmaceuticals, Inc. · BLA761244
Product NDC: 0597-0035
SPL effective 2026-04-08 | SPL version 7. 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.