IMAAVY™
(nipocalimab-aahu)
Medical inquiries
This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
IMAAVY™ (nipocalimab-aahu)
Medical Information
IMAAVY – Stability of Final Vialed Product for Intravenous Infusion
Last Updated: 04/29/2025
SUMMARY
- Johnson & Johnson cannot recommend any practices, procedures, or storage conditions that deviate from the product labeling.
- Please refer to local labeling for storage, stability, and handling information for IMAAVY 300 mg and 1200 mg (185 mg/mL) single-dose vials for intravenous infusion.
Stability and temperature excursion data
This information is provided in response to your unsolicited request.
- This data is based on analyses from a strictly controlled environment. Johnson & Johnson cannot support the return to the recommended storage condition after temperature excursion from the data listed below.
- Stability analyses were conducted with IMAAVY 300 mg and 1200 mg (185 mg/mL) single-dose vials for intravenous use to provide the proven limits for temperature excursions that vary from the recommended storage condition of 2°C to 8°C (36°F to 46°F).1
- Based on the stability data, the proven limits for temperature excursions for IMAAVY
300 mg and 1200 mg (185 mg/mL) single-dose vials for intravenous use are defined in Table: Proven Limits for Temperature Excursions.1
| Up to 12 Months Shelf Life | |
|---|---|
| Temperature Excursion | Proven Limit |
| -20˚C to <2˚C | Maximum of 5 exposures, with each exposure not exceeding 48 hours |
| 2˚C to 8˚C | In compliance |
| >8˚C to 30˚C | Maximum of 5 exposures, with each exposure not exceeding 48 hours |
| >12 to up to 18 Months Shelf Life | |
| Temperature Excursion | Proven Limit |
| -20˚C to <2˚C | Maximum of 1 hour |
| 2˚C to 8˚C | In compliance |
| >8˚C to 30˚C | Maximum of 1 hour |
References
| 1 | Data on File. Technical Document Recommended Storage Conditions, Shelf Life, and Temperature Excursion Guidelines for Nipocalimab 1200mg/vial and 300 mg/vial Drug Product for Commercial Use. Janssen Research and Development, LLC. TV-TEC-308351; 2025. |