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.

The minimum overfill volumes of 0.25 mL (for 100 mg/vial) and 0.75 mL (for 300 mg/vial) were established to ensure a target concentration of 20 mg/mL zolbetuximab after reconstitution, resulting in minimum fill volumes of 5.25 mL and 15.75 mL, respectively.

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.

Table 2. Overfill volume per vial1 

Vial sizea

Diluent added

for reconstitution

(SWFI)

Minimum overfill

volume

Minimum fill volume after

reconstitution

Final concentration

100 mg/vial

5.0 mL

0.25 mL

5.25 mL

20 mg/mL

300 mg/vial

15.0 mL

0.75 mL

15.75 mL

20 mg/mL

SWFI: sterile water for injection.

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

References

1. Data on File.

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