STELARA®
(ustekinumab)
Medical inquiries
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STELARA® (ustekinumab)
Medical Information
STELARA - Stability of Final Vialed Product for Intravenous Infusion
Last Updated: 01/02/2025
Summary
- Please refer to local labeling for storage, stability, and handling information for STELARA 130 mg/26 mL (5 mg/mL) final vialed product for intravenous use.
- Janssen Research & Development, LLC. cannot recommend any practices, procedures, or storage conditions that deviate from the product labeling.
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. Janssen Research & Development, LLC. cannot support the return to the recommended storage condition after temperature excursion from the data listed below.
- Stability analyses were conducted with STELARA 5 mg/mL final vialed product for intravenous use (130 mg/vial) 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). Based on the stability data, the proven limits for temperature excursions for STELARA 5 mg/mL final vialed product (for intravenous use) are defined in Table: Proven Limits for Temperature Excursions.1
, 2
| Temperature Excursion | Proven Limit |
|---|---|
| -20°C to 1°C | No longer than 6 consecutive days |
| 2°C to 8°C | In compliance |
| 9°C to 25°C | No longer than 3 consecutive days |
References
| 1 | Data on File. Technical Document Commercial Shelf-life Statement and Temperature Excursion Limit for Stelara FVP (IV) commercial and clinical active and placebo v6. Janssen Research & Development, LLC; 2021. |
| 2 |