Eculizumab-aeeb (Bkemv)
Dilution requiredFull monograph review pending
U.S. label preparation
Bkemv · Dilution required
- Preparation
- Add an equal volume of diluent to the 10 mg/mL concentrate for a final concentration of 5 mg/mL. Labeled options include 0.9% sodium chloride, 0.45% sodium chloride, 5% dextrose or Ringer's Injection, USP.
- Administration and handling
- Gently invert to mix and allow the infusion to reach room temperature before administration. Select the infusion time from the product label for the age group.
Product and source details
Amgen Inc · BLA761333
Product NDC: 55513-180
SPL effective 2026-07-02 | SPL version 8. 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.