Summary

• Please refer to local product labeling for drug product preparation, administration, 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

• TALVEY 2 mg/mL vial and TALVEY 40 mg/mL vial are supplied as ready-to-use solutions that do not need dilution prior to administration.¹ 
• TALVEY 2 mg/mL vial and TALVEY 40 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

• The prepared syringe should be administered immediately.¹
• If immediate administration is not possible, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours followed by storage at ambient temperature of 15°C to 30°C (59°F to 86°F) for up to 24 hours. Discard if stored for more than 24 hours refrigerated or more than 24 hours of being at ambient temperature.¹
• Based on the results of the in-use stability and compatibility study and microbial challenge studies, the maximum in-use time for the drug product is restricted to 48 hours (including preparation, hold, administration): comprising storage at 2°C to 8°C up to 24 hours and storage at 15°C to 30°C up to 24 hours.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 13 February 2025.