LEQEMBI Solution for injection Ref.[107292] Active ingredients: Lecanemab

Source: FDA, National Drug Code (US)  Revision Year: 2023 

Product description

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 (lecanemab-irmb) injection is a preservative-free, sterile, clear to opalescent and colorless to pale yellow solution for intravenous use by 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.

Dosage Forms and Strengths

LEQEMBI is a clear to opalescent and colorless to pale yellow solution, available as:

  • Injection: 500 mg/5 mL (100 mg/mL) in a single-dose vial
  • Injection: 200 mg/2 mL (100 mg/mL) in a single-dose vial
How Supplied

LEQEMBI (lecanemab-irmb) injection is a preservative-free, sterile, clear to opalescent, and colorless to pale yellow solution. LEQEMBI is supplied one vial per carton as follows:

  • 500 mg/5 mL (100 mg/mL) single-dose vial (with white flip cap) – NDC 62856-215-01
  • 200 mg/2 mL (100 mg/mL) single-dose vial (with dark grey flip cap) – NDC 62856-212-01

Manufactured by: Eisai Inc., Nutley, NJ 07110, U.S. License No. 1862

Drugs

Drug Countries
LEQEMBI United States
 
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