Leqembi Generic Name & Formulations
Single-dose vial (2mL, 5mL)—1
Mechanism of Action
Lecanemab-irmb is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. Leqembi reduces amyloid beta plaques.
Alzheimer’s disease in mild cognitive impairment or mild dementia.
Leqembi Dosage and Administration
Confirm the presence of amyloid beta pathology prior to initiation. Give 10mg/kg by IV infusion over ~1hr, once every 2 weeks. Dosing recommendations for patients with amyloid related imaging abnormalities -edema (ARIA-E) and -hemosiderin deposition (ARIA-H): see full labeling.
Leqembi Boxed Warnings
Amyloid related imaging abnormalities.
Risk of amyloid related imaging abnormalities (ARIA); with edema (ARIA-E) or with hemosiderin deposition (ARIA-H). Consider the benefit/risk of serious adverse events associated with ARIA prior to initiation. Obtain a recent MRI prior to initiation, then prior to 5th, 7th, and 14th infusions. Perform clinical evaluation if symptoms suggestive of ARIA occur (esp during 1st 14 weeks), including MRI if indicated. Increased risk of ARIA in those who are apolipoprotein E ε4 (ApoE ε4) homozygotes. Perform testing for ApoE ε4 status prior to initiation. Patients with risk factors for intracerebral hemorrhage (eg, prior cerebral hemorrhage >1cm in greatest diameter, >4 microhemorrhages, superficial siderosis, vasogenic edema, aneurysm, vascular malformation). Discontinue at 1st signs/symptoms of hypersensitivity reaction and treat appropriately. Discontinue or reduce infusion rate if an infusion-related reaction occurs; consider prophylaxis with antihistamines, APAP, NSAIDs, or corticosteroids prior to future infusions. Pregnancy. Nursing mothers.
Steady state concentrations of lecanemab-irmb were reached after 6 weeks of 10 mg/kg administered every 2 weeks and systemic accumulation was 1.4-fold.
The peak concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of lecanemab-irmb increased dose proportionally in the dose range of 0.3–15 mg/kg following single dose.
The mean value (95% CI) for central volume of distribution at steady-state is 3.22 (3.15–3.28) L.
Half-life: 5–7 days.
Caution with concomitant antithrombotics (eg, aspirin, other antiplatelets, or anticoagulants) or a thrombolytic agent (eg, tissue plasminogen activator).
Leqembi Adverse Reactions
Infusion-related reactions, amyloid related imaging abnormality-microhemorrhages, amyloid related imaging abnormality-edema/effusion, headache, cough, diarrhea.
Leqembi Clinical Trials
Leqembi Patient Counseling