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What is the approved final concentration of zolbetuximab?

Published

In the United States, zolbetuximab should be diluted to a final concentration of 5 mg/mL for intravenous infusion

Zolbetuximab is reconstituted with sterile water for injection and diluted with 0.9% w/v sodium chloride solution for injection to a final concentration of 5 mg/mL.1 Although the use of zolbetuximab infusion solution concentrations between 2 mg/mL and 5 mg/mL may be accepted based on in-use stability studies, including physicochemical compatibility and microbial challenge studies,2 concentrations other than 5 mg/mL are not approved for use in the United States.1

  1. VYLOY [package insert]. Northbrook, IL, USA: Astellas Pharma, Inc. Available at: https://www.astellas.com/us/system/files/vyloy_pi.pdf. [Product Label]

  2. Data on File.

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