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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.

TALVEY® (talquetamab-tgvs)

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TALVEY - Total Fill Volume and Extractable Volume in Vials

Last Updated: 07/29/2024

SUMMARY

Due to the viscosity of TALVEY, 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 TALVEY 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 the table below.²

Total and Extractable Volume in Vials¹^,²

Vial	Total Fill Volume	Extractable Volume
TALVEY 2 mg/mL (2 mg/mL concentration)	2.0 mL	1.5 mL
TALVEY 40 mg/mL (40 mg/mL concentration)	1.4 mL	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 26 July 2024.

References

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1	Data on File. Data on File. Janssen Scientific Affairs, LLC. Correspondence from Research and Development, LLC. (Communication dated 19 May 2023); 2023.
2	Data on File. PPQ Report for JNJ-64407564 (GPRC5DxCD3, Talquetamab) 2 mg/mL and 40 mg/mL final vialed products (FVPs) in manufacturing area 3 and filling line 2 at Patheon, Greenville. TV-VAL-241650; version 2.0; 2024.