lecanemab-irmb injection
lecanemab-irmb injection,
for intravenous use Initial U.S. Approval: 2023
As specified in the prescribing information, Leqembi is indicated for the treatment of Alzheimer’s disease. The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.
Facts about lecanemab-irmb injection
DOSAGE FORMS AND STRENGTHS: Package
• 500 mg/5 mL (100 mg/mL) solution in a single-dose vial.
• 200 mg/2 mL (100 mg/mL) solution in a single-dose vial.
DISEASE INDICATIONS: Alzheimer’s disease
MANUFACTURER: Eisai Europe Ltd
USAGE: Intravenous
MEDICINE APPROVED BY: Food and Drug Administration (FDA)
Extra Information:
- Full prescribing information [FDA]: (PDF) Click Here
- FDA grants accelerated approval for Alzheimer’s disease treatment FDA, January 2023
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Query For lecanemab-irmb injection
Approved accessible "lecanemab-irmb injection"
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.
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.
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