What is the vial overfill in a 100mg or 300mg zolbetuximab vial?

Published

The 100 mg and 300 mg vials of zolbetuximab contain an overfill of 5 mg/vial and 15 mg/vial, respectively, to ensure the intended deliverable dose

Zolbetuximab must be reconstituted with 5.0 mL (100 mg/vial) or 15.0 mL (300 mg/vial) of sterile water for injection, which gives a solution concentration of 20 mg/mL in a vial.1 The extractable amount of zolbetuximab after reconstitution will be either 100 mg or 300 mg.

Table 1. Amount of active ingredient per vial1

Component

Amount per 100 mg vial

Amount per 300 mg viala

Zolbetuximab

105 mg

315 mg

a Not all vial sizes of zolbetuximab may be approved in your country. Please refer to the local prescribing label for further information.

  1. Data on File. 

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