Donanemab-azbt is available as a 17.5-mg/mL concentrate for injection in 20-mL preservative-free, single-dose vials containing 350 mg of the drug.4009 Each mL of the concentrate contains donanemab 17.5 mg with anhydrous citric acid 0.32 mg, polysorbate 80 0.20 mg, sodium citrate 2.15 mg, and sucrose 80 mg in water for injection.4009
The concentrate must be diluted prior to administration.4009 Vials should be allowed to equilibrate to room temperature before use.4009 To prepare the drug for intravenous infusion, the appropriate dose of the concentrate should be withdrawn from the vial and added to a volume of sodium chloride 0.9% to yield a final donanemab concentration of 4 to 10 mg/mL.4009 The manufacturer’s instructions for preparing donanemab-azbt for infusion are as follows:4009
For a 700-mg dose, 40 mL of the concentrate (2 vials) should be added to 30 to 135 mL of sodium chloride 0.9% to a final volume of 70 to 175 mL.
For a 1400-mg dose, 80 mL of the concentrate (4 vials) should be added to 60 to 270 mL of sodium chloride 0.9% to a final volume of 140 to 350 mL.
The solution should be mixed by gentle inversion; do not shake.4009 Any unused portion remaining in vials should be discarded.4009
pH
Concentrate for injection: 5.5 to 6.5.4009
Trade Name(s)
Kisunla
Donanemab is administered by intravenous infusion over approximately 30 minutes only after dilution in sodium chloride 0.9%.4009 The infusion line should be flushed only with sodium chloride 0.9% following administration per access specific line maintenance protocol.4009
Refrigerated solutions should be allowed to come to room temperature prior to administration.4009
The concentrate for injection is a clear to opalescent, colorless to slightly yellow to slightly brown solution.4009 Visually inspect vials prior to use; do not use the solution if discoloration or particulate matter is present.4009
Intact vials should be stored at 2 to 8°C in the outer carton to protect from light.4009 Do not freeze or shake.4009 If refrigeration is not available, intact vials may be stored at room temperature (20 to 25°C) for up to 3 days.4009
The manufacturer states diluted solutions may be stored for up to 12 hours at room temperature (20 to 25°C) or 72 hours refrigerated (2 to 8°C), including administration time.4009 Diluted solutions should not be frozen.4009 If refrigerated, diluted solutions should be allowed to come to room temperature prior to administration.4009
For a list of references cited in the text of this monograph, search the monograph titled References.