What is the mass of zolbetuximab and excipients in 300 mg vials?

Published

Prescribing Information including BOXED WARNING

A 300 mg vial contains extractable zolbetuximab 300 mg, arginine 348.6 mg, sucrose 769.44 mg, polysorbate 80 3.15 mg and phosphoric acid max 179.1 mg

The maximum extractable amount of phosphoric acid per 300 mg vial is estimated at 179.1 mg from historical batches calculated based on 100 mg/vial, corresponding to 3.8 mg/mL of phosphorous after reconstitution.¹

Table 1. Composition of zolbetuximab 300 mg vial^a,¹

Component	Extractable amount^b	Theoretical unit amount^c
Zolbetuximab	300 mg	315 mg^d
Arginine	348.6 mg	366 mg
Phosphoric acid	sufficient quantity to pH 6.0^e	sufficient quantity to pH 6.0^e
Sucrose	769.44 mg	807.9 mg
Polysorbate 80	3.15 mg	3.3 mg

^aNitrogen gas is used for backfilling and contained in the headspace of zolbetuximab vial.

^bExtractable amount refers to the quantity that a trained healthcare professional should be able to retrieve from the reconstituted solution when following the recommended reconstitution and extraction procedures.

^cTheoretical amount refers to the quantity of zolbetuximab and excipients added to the vial to enable extraction of 300 mg of zolbetuximab.

^dEach vial contains an overfill of zolbetuximab relative to the nominal content (300 mg/vial) to ensure the deliverable dose is provided in each vial.

^eThe estimated maximum extractable amount of phosphoric acid per vial is estimated at 179.1 mg from historical batches calculated based on 100 mg/vial, corresponding to 3.8 mg/mL of phosphorous after reconstitution. The upper limit for extractable amount of phosphoric acid per vial based on safety data is 203.7 mg/vial (300 mg/vial).