Mosunetuzumab-axgb is available as a 1-mg/mL concentrate for injection in 1- and 30-mL preservative-free single-dose vials.3975 Each 1-mL vial contains mosunetuzumab-axgb 1 mg, acetic acid 0.4 mg, histidine 1.6 mg, methionine 1.5 mg, polysorbate 20 0.6 mg, and sucrose 82.1 mg in water for injection.3975 Each 30-mL vial contains mosunetuzumab-axgb 30 mg, acetic acid 12.8 mg, histidine 46.6 mg, methionine 44.8 mg, polysorbate 20 18 mg, and sucrose 2462.4 mg in water for injection.3975 The concentrate for injection must be diluted in sodium chloride 0.9 or 0.45% prior to administration.3975 To prepare a diluted solution for administration, a volume of infusion solution equivalent to the volume of the concentrate for injection to be added should be removed from an infusion bag containing sodium chloride 0.9 or 0.45% before transferring the appropriate volume of mosunetuzumab-axgb concentrate for injection to the infusion bag.3975 The size of the infusion bag depends on the dose of mosunetuzumab-axgb; doses of 1 or 2 mg may be diluted in a 50- or 100-mL infusion bag, doses of 30 mg may be diluted in a 50-, 100-, or 250-mL infusion bag, and doses of 60 mg should be diluted in a 100- or 250-mL infusion bag.3975 The diluted solution should be mixed gently by inversion; do not shake.3975
pH
The concentrate for injection has a pH of 5.8.3975
Trade Name(s)
Lunsumio
Mosunetuzumab-axgb is administered by intravenous infusion over a minimum of 2 or 4 hours, depending on the treatment cycle.3975 Diluted solutions for infusion should be at room temperature at the time of infusion.3975
Intact vials should be stored at 2 to 8°C in the original carton to protect from light.3975 Do not freeze or shake.3975
Mosunetuzumab-axgb concentrate for injection is a colorless solution; do not use if the solution is discolored, cloudy, or contains particulate matter.3975
Diluted solutions may be stored for up to 24 hours at 2 to 8°C, or up to 16 hours at ambient room temperature (9 to 30°C).3975 If refrigerated, diluted solutions should be allowed to come to room temperature prior to administration.3975
Sorption
Manufacturer states the final diluted solution for infusion should be prepared only in infusion bags composed of polyvinyl chloride (PVC) or polyolefins such as polyethylene and polypropylene.3975
In addition, no incompatibilities have been observed between mosunetuzumab-axgb and infusion sets or products containing PVC, polyethylene, polyurethane, polybutadiene, silicone, acrylonitrile butadiene styrene, polycarbonate, polyetherurethane, fluorinated ethylene propylene, or polytetrafluorethylene, or with drip chamber filter membranes composed of polyamide.3975
Filtration
Manufacturer states that an inline filter should not be used for administration.3975
For a list of references cited in the text of this monograph, search the monograph titled References.