SUMMARY

• Please refer to the local prescribing information for storage and stability information.
• Janssen cannot recommend any practices, procedures, or storage conditions that deviate from product labeling and are not approved by the regulatory agencies.
• This information is provided in response to your unsolicited request and provides information on specific scenarios for which we have data. If there is no tracking of time and temperature, Janssen cannot provide recommendations.
• 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. The data cannot be used to evaluate the impact of temperature excursions at point-of-use without a comprehensive understanding of the total excursion history during product shipment/storage when the product is in the Janssen chain of custody.
• As temperature excursion data may be updated periodically, please contact Janssen for any future temperature excursions. 

Temperature Excursion Data

• TECVAYLI 10 mg/mL vial and TECVAYLI 90 mg/mL vial are supplied as single-dose, ready-to-use solutions that do not need dilution prior to administration.^1,2 
• TECVAYLI 10 mg/mL vial and TECVAYLI 90 mg/mL vial should be stored at 2°C to 8°C (36°F to 46°F) in the original carton in order to protect from light. Do not freeze.¹ 
• Stability studies were conducted with TECVAYLI to provide the acceptable limits for temperature excursions outside of the recommended storage condition.³
• Based on the stability data, there is no anticipated adverse impact to the TECVAYLI 10 mg/mL vial and TECVAYLI 90 mg/mL vial when exposed to temperatures within the proven limits described in Table: Temperature Excursion Guidelines for TECVAYLI Vials.³

literature search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 19 December 2024.