(ustekinumab)
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.
STELARA® (ustekinumab)
Medical Information
Storage and Stability of STELARA Final Vialed Product for Subcutaneous Use
Last Updated: 01/02/2025
COMPANY CORE DATA SHEET
Storage Conditions1
- Store in a refrigerator
- 2ºC to 8ºC
- 36ºF to 46ºF
- Store in original carton until time of use
- Protect from light
- Do not freeze
- Do not shake
Technical memorandum
Janssen Biotech, Inc. cannot recommend any practices, procedures, or storage conditions that deviate from the product labeling. Data are available for situations outside the recommended storage requirements. This information is in response to your unsolicited request.
Temperature Excursions
Stability studies indicated that STELARA Final Vialed Product (FVP) for subcutaneous use may be exposed 1 time only to temperatures above 10°C (50°F) and not exceeding 25°C (77°F) for no more than 4 hours under standard room lighting (not excess lighting), during handling onsite by a healthcare professional. Within those 4 hours, the product should be used and not refrigerated at 2°C to 8°C (36°F to 46°F).2