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.

Stability of INVEGA SUSTENNA at Elevated Temperature Excursion

Last Updated: 07/18/2024

Summary

  • Please refer to local prescribing information for storage and stability information.
  • Janssen cannot recommend any practices, procedures, or storage conditions that deviate from the product labeling and are not approved by regulatory authorities.
  • Store at room temperature (25°C, 77°F); excursions between 15°C and 30°C (between 59°F and 86°F) are permitted.1

STABILITY AND TEMPERATURE EXCURSION DATA

Data is available for situations outside of recommended storage requirements. This information is provided in response to your unsolicited request. These data were collected in strictly controlled environments. It is not possible to predict and design studies that reflect every combination or duration of temperatures that a customer’s product may encounter. Therefore, caution is recommended in assessing the effects of specific excursions on a product.

Stability studies were conducted with INVEGA SUSTENNA to provide the acceptable limits for temperature excursions outside of the recommended storage condition. Based on the stability data, INVEGA SUSTENNA was not adversely affected when exposed to conditions within the acceptable limits.


Proven Limits for Temperature Excursions2
Excursion Temperature Range
Acceptable Limit
30°C - 40°C (86°F - 104°F)
1 month
40°C - 50°C (104°F - 122°F)
2 days

References

1 INVEGA SUSTENNA (paliperidone palmitate) extended-release injectable suspension [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVEGA+SUSTENNA-pi.pdf.  
2 Technical Document Proven Temperature Ranges for JSC Drug Products. TV-TEC-102593. 2023.