Summary

• Please refer to local product labeling 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.
• The in-use stability times were based on data that were collected in strictly controlled environments.

How Supplied

• TECVAYLI 10 mg/mL vial and TECVAYLI 90 mg/mL vial are supplied as ready-to-use solutions that do not need dilution prior to administration.¹
• TECVAYLI 10 mg/mL vial and TECVAYLI 90 mg/mL vial should be stored refrigerated at 2°C to 8°C in the original carton in order to protect from light. Do not freeze.¹

In-Use Stability

• Drug product preparation and administration should conform to the conditions specified in the product labeling.²
• If the prepared dosing syringe(s) of TECVAYLI is not used immediately, store at 2°C to 8°C or at ambient temperature for a maximum of 20 hours. Discard after 20 hours, if not used.¹
• The 20-hour in-use time of the prepared syringe was set as a control limit based on the chemical/physical stability and microbial stability times that were demonstrated during controlled in-use/compatibility studies.²
• From a microbiological point of view, unless the method of opening precludes the risks of microbial contamination, the product should be used within 20 hours. If not used as per approved conditions, in-use storage times and conditions prior to use are the responsibility of the user.²

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 23 October 2024.