TECVAYLI - In-use Stability

Summary

• Please refer to local product labeling for storage and stability information.
• Johnson and Johnson 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 TECVAYLI is not used immediately, store refrigerated at 2°C-8°C for a maximum of 8 days or at ambient temperature for a maximum of 24 hours. If TECVAYLI is not used immediately, discard after 24 hours if stored at ambient temperature or after 8 days if refrigerated.¹
• The in-use times of 8 days at 2°C-8°C and 24-hours at ambient temperature of the prepared syringe were set as control limits 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 the in-use stability timing mentioned above. 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 5 August 2026.