Dostarlimab-gxly is available as a 50-mg/mL concentrate for injection in 10-mL preservative-free, single-dose vials containing 500 mg of the drug.3884 Each mL of the concentrate contains dostarlimab 50 mg with citric acid monohydrate 0.48 mg, L-arginine hydrochloride 21.07 mg, polysorbate 80 0.2 mg, sodium chloride 1.81 mg, and trisodium citrate dihydrate 6.68 mg in water for injection.3884
The concentrate must be diluted prior to administration.3884 To prepare a 500-mg dose for intravenous infusion, withdraw 10 mL of the concentrate from the vial using a prolypropylene syringe and dilute in up to 250 mL of dextrose 5% or sodium chloride 0.9% to yield a final dostarlimab concentration between 2 and 10 mg/mL.3884 To prepare a 1000-mg dose for intravenous infusion, withdraw a total of 20 mL of the concentrate from 2 vials using a prolypropylene syringe and dilute in up to 250 mL of dextrose 5% or sodium chloride 0.9% to yield a final dostarlimab concentration between 4 and 10 mg/mL.3884 The solution should be mixed by gentle inversion and should not be shaken.3884 Any unused portion remaining in vials should be discarded.3884
pH
6.3884
Trade Name(s)
Jemperli
Dostarlimab is administered by intravenous infusion over 30 minutes only after dilution in dextrose 5% or sodium chloride 0.9%.3884 Tubing composed of polyvinyl chloride or platinum cured silicone with fittings composed of polyvinyl chloride or polycarbonate should be used to administer the diluted solution for infusion; a 0.2-µm low protein-binding add-on or inline filter also should be used.3884
Other drugs should not be co-administered with dostarlimab through the same infusion line.3884
Intact vials of dostarlimab-gxly should be stored at 2 to 8°C in the original carton to protect from light and should not be shaken or frozen.3884 The concentrate for injection is a clear to slightly opalescent, colorless to yellow solution.3884 Vials should be visually inspected for particulate matter and discoloration prior to use; discard the solution if particulate matter is present.3884
The manufacturer states diluted solutions may be stored for no more than 6 hours at room temperature or 24 hours at 2 to 8°C, including administration time.3884 Diluted solutions should be discarded after 6 hours at room temperature or 24 hours at 2 to 8°C.3884 Refrigerated solutions should be allowed to come room temperature prior to administration.3884 Diluted solutions should not be frozen.3884
Sorption
The manufacturer states that infusion bags composed of polyolefin, ethylene vinyl acetate, or polyvinyl chloride (PVC) with diethylhexyl phthalate (DEHP) may be used for preparation of diluted solutions.3884 Diluted solutions should be administered using tubing composed of polyvinyl chloride or platinum cured silicone with fittings composed of polyvinyl chloride or polycarbonate.3884
Filtration
Diluted solutions for infusion should be administered through a 0.2-µm low protein-binding add-on or inline filter.3884
For a list of references cited in the text of this monograph, search the monograph titled References.