Alzheimer's dementia:

Indications for: LEQEMBI

Alzheimer’s disease in mild cognitive impairment or mild dementia.

Adult Dosage:

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.

Children Dosage:

Not established.

Boxed Warning:

Amyloid related imaging abnormalities.

LEQEMBI Warnings/Precautions:

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.

LEQEMBI Classification:

Amyloid beta-directed antibody.

LEQEMBI Interactions:

Caution with concomitant antithrombotics (eg, aspirin, other antiplatelets, or anticoagulants) or a thrombolytic agent (eg, tissue plasminogen activator).

Adverse Reactions:

Infusion-related reactions, amyloid related imaging abnormality-microhemorrhages, amyloid related imaging abnormality-edema/effusion, headache, cough, diarrhea.

Metabolism:

Degraded by proteolytic enzymes in the same manner as endogenous IgGs.

Drug Elimination:

Half-life: 5–7 days.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (2mL, 5mL)—1