SPL Set ID: 9d1ff786-e577-410a-a273-c4d7d0e4e975

Lecanemab-irmb is a recombinant humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta, and is expressed in a Chinese hamster ovary cell line. Lecanemab-irmb has an approximate molecular weight of 150 kDa. LEQEMBI Injection for Intravenous Use LEQEMBI (lecanemab-irmb) injection is a sterile, preservative-free, clear to opalescent and colorless to pale yellow solution for intravenous infusion after dilution. LEQEMBI is supplied in single-dose vials available in concentrations of 500 mg/5 mL (100 mg/mL) or 200 mg/2 mL (100 mg/mL). Each mL of solution contains 100 mg of lecanemab-irmb and arginine hydrochloride (42.13 mg), histidine (0.18 mg), histidine hydrochloride monohydrate (4.99 mg), polysorbate 80 (0.50 mg), and Water for Injection at an approximate pH of 5.0. LEQEMBI IQLIK Injection for Subcutaneous Use LEQEMBI IQLIK (lecanemab-irmb) injection is a sterile, preservative-free, clear to opalescent and colorless to pale yellow solution for subcutaneous use. LEQEMBI IQLIK is supplied in a single-dose prefilled autoinjector available in the concentration of 360 mg/1.8 mL with a 29-gauge fixed ½-inch needle. Each LEQEMBI IQLIK autoinjector contains 360 mg/1.8 mL lecanemab-irmb formulated in: arginine hydrochloride (75.83 mg), histidine (0.25 mg), histidine hydrochloride monohydrate (9.09 mg), polysorbate 80 (0.90 mg), and Water for Injection, USP.