Nipocalimab-aahu (Imaavy)
Dilution requiredFull monograph review pending
U.S. label preparation
Imaavy · Dilution required
- Preparation
- Use only 0.9% sodium chloride. The prepared total volume is 100 mL below 40 kg or 250 mL at 40 kg and above.
- Administration and handling
- Use the patient-specific dose volume and follow the label's infusion-rate and monitoring instructions.
Product and source details
Janssen Biotech, Inc. · BLA761430
Product NDC: 57894-801, 57894-800
SPL effective 2026-08-21 | SPL version 5. 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.