This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
SUMMARY
- Due to the viscosity of TECVAYLI, it is not possible to extract the entire solution out of the vial. To account for this, the total fill volume in the current vial formats for TECVAYLI is more than the indicated extractable volume.1
- The additional volume provided in the vials is necessary to ensure accurate and sufficient dose withdrawal.1
- Details are provided in Table: Total and Extractable Volume in Vials.
Total and Extractable Volume in Vials2,3
| Total Fill Volume
| Extractable Volume
|
| 3.5 mL
| 3.0 mL
|
| 2.0 mL
| 1.7 mL
|
Literature Search
A literature search of Ovid MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 07 May 2026.
| 1 | Data on File. Janssen Scientific Affairs, LLC. Correspondence from Research and Development, LLC. (Communication dated 07 May 2026); 2026. |
| 2 | Data on File. Detailed Process Flow Diagram to Support Product and Process Qualification of BCMAxCD3 (Teclistamab, BCMAxCD3) 90 mg/mL and 10 mg/mL FVP at Patheon, Greenville, NC. TV-TEC-184647; version 12.0; 2026. |
| 3 | Data on File. Process Performance Qualification Report (6 PPQ batches) for JNJ-64007957 (BCMAxCD3, teclistamab) 10 mg/mL and 90 mg/mL Final Vialed Products (FVPs) at Manufacturing Area 3 and Filling Line 2 at Patheon, Greenville, NC. TV-VAL-241829; version 2.0; 2023. |