Lecanemab-irmb is available as a 100-mg/mL concentrate for injection in 2- or 5-mL preservative-free, single-dose vials containing 200 or 500 mg, respectively, of the drug.4015 Each mL of the concentrate contains lecanemab 100 mg with arginine hydrochloride 42.13 mg, histidine 0.18 mg, histidine hydrochloride monohydrate 4.99 mg, and polysorbate 80 0.50 mg in water for injection.4015
The concentrate must be diluted prior to administration.4015 The appropriate dose of the concentrate should be withdrawn from the necessary number of vials and diluted in an infusion bag containing 250 mL of sodium chloride 0.9%.4015 The solution should be mixed by gentle inversion; do not shake.4015 Any unused portion remaining in vials should be discarded.4015
pH
Concentrate for injection: Approximately 5.4015
Trade Name(s)
Leqembi
Lecanemab is administered by intravenous infusion over approximately 1 hour through an intravenous line with a terminal low-protein binding 0.2-µm inline filter.4015 Following administration, the infusion line should be flushed with a compatible infusion solution to ensure delivery of the full dose.4015
Diluted solutions should be allowed to come to room temperature prior to administration.4015
The concentrate for injection is a clear to opalescent, colorless to pale yellow solution.4015 Visually inspect vials prior to use; do not use if particulate matter or discoloration is present.4015
Intact vials should be stored at 2 to 8°C in the outer carton to protect from light.4015 Do not freeze or shake.4015
Diluted solutions may be stored for up to 4 hours at 2 to 8°C or room temperature up to 30°C.4015 Diluted solutions should not be frozen.4015 If refrigerated, diluted solutions should be allowed to come to room temperature prior to administration.4015
Filtration
Diluted solutions for infusion should be administered through a terminal low-protein binding 0.2-µm inline filter.4015
For a list of references cited in the text of this monograph, search the monograph titled References.