SUMMARY  

• In clinical trials, the use of closed system transfer devices (CSTDs) was permitted for the preparation and administration of TECVAYLI for syringe volumes ≥1mL. Commercially available CSTDs could be used in the preparation and administration of TECVAYLI provided the guidelines below are followed¹:
  • The holdup volumes of the CSTD components (e.g, vial spike and syringe adapter) must be accounted for when drawing up the dose as this will impact the number of TECVAYLI vials required to prepare the dose.
  • For dose administration, holdup volumes of the CSTD must be accounted for during the preparation of the syringe(s) to ensure that the exact subcutaneous injection volume is in the syringe post priming the CSTD.
• For syringe volumes less than 1 mL, CSTDs must not be used for dose preparation or administration.¹

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 05 August 2024.