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TECVAYLI - Needle Specifications in Clinical Trials

Last Updated: 02/28/2025

Abbreviations: G, gauge.
aData on File (2024).1 bData on File (2024).2

SUMMARY

  • TECVAYLI is compatible with stainless steel injection needles.1
  • Replace the transfer needle with an appropriately sized needle for injection.1
  • In clinical trials, the following ancillary supplies for preparation and administration were specified2:
    • Preparation: 18-27G needle was required for the preparation of TECVAYLI.2
    • Administration:
      • TECVAYLI step-up doses (10 mg/mL vial) and treatment doses (90 mg/mL vial): 25-31G needle, 8-16 mm in length was required for the administration of TECVAYLI.2
      • TECVAYLI treatment doses (90 mg/mL vial): For administration of TECVAYLI treatment doses, a 25-27G needle, 8-16 mm in length was recommended due to the higher viscosity.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 19 February 2025.

 

References

1 Data on File. Teclistamab. CCDS. Janssen Research & Development, LLC. Dated 25 October 2024. EDMS-RIM-378072; Version 008; 2024.  
2 Data on File. Investigational Product Preparation and Administration Instructions for Subcutaneous Administration of 10 mg/mL and 90 mg/mL Teclistamab (JNJ-64007957) for Weight-Based Dosing in mg/kg. Dated 13 November 2024. TV-TEC-208759; Version 6.0; 2024.