LEQEMBI is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. Treatment should be initiated in patients with mild cognitive impairment or mild dementia stage of disease.

1. Absorption: The bioavailability of lecanemab-irmb following subcutaneous administration of 360 mg by autoinjector relative to a 10 mg/kg intravenous infusion is approximately 53%. 2. Distribution: The mean central volume of distribution at steady state is 3.24 L. 3. Elimination: It is degraded by proteolytic enzymes in the same manner as endogenous IgGs. The clearance is 0.370 L/day, and the terminal half-life is 5 to 7 days.

Serious hypersensitivity to lecanemab-irmb or its excipients.

No adequate human or animal data available.

There are no data on the presence of lecanemab-irmb in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.

The most common adverse reactions (at approximately 10% and higher incidence compared to placebo) are infusion-related reactions, amyloid related imaging abnormality-microhemorrhages (ARIA-H), amyloid related imaging abnormality-edema/effusion (ARIA-E), and headache.

Prior to treatment: Confirm the presence of amyloid beta pathology and obtain a recent baseline brain MRI. Starting dosage: 10 mg/kg once every 2 weeks administered after dilution as an intravenous infusion over approximately one hour. Maintenance dosage (after 18 months): * Intravenous infusion: 10 mg/kg once every 4 weeks. Subcutaneous injection: 360 mg administered once a week using the LEQEMBI IQLIK autoinjector.

Safety and effectiveness not established.

No clinical studies were conducted to evaluate the pharmacokinetics of lecanemab-irmb in patients with renal impairment. However, the drug is degraded by proteolytic enzymes and is not expected to undergo renal elimination. (No specific dose adjustment is provided).

No clinical studies were conducted to evaluate the pharmacokinetics of lecanemab-irmb in patients with hepatic impairment. It is not expected to undergo metabolism by hepatic enzymes. (No specific dose adjustment is provided).

Unopened (IV/SC): Refrigerate at 2°C to 8°C, protect from light, do not freeze. Diluted IV: Use immediately; otherwise, store up to 4 hours at 2°C to 8°C or room temp up to 30°C.SC Autoinjector: Can be stored at room temp up to 25°C for 14 days; do not re-refrigerate.