Leqembi

Adults w/ clinical diagnosis of mild cognitive impairment & mild dementia due to Alzheimer's disease (Early Alzheimer's disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes w/ confirmed amyloid pathology.

IV infusion 10 mg/kg once every 2 wk.

Hypersensitivity. Patients w/ bleeding disorders that are not under adequate control. Pre-treatment MRI findings of prior intracerebral haemorrhage, >4 microhaemorrhages, superficial siderosis or vasogenic oedema, or other findings suggestive of cerebral amyloid angiopathy. Ongoing anticoagulant therapy.

Hypersensitivity reactions including angioedema, bronchospasm & anaphylaxis. Permanently discontinue treatment if intracerebral haemorrhage >1 cm diameter occurs. Promptly discontinue infusion upon 1st observation of signs & symptoms consistent w/ hypersensitivity-type reaction. Discontinue or reduce infusion rate in the event of an infusion-related reaction. Discontinue treatment once patient progresses to moderate Alzheimer's disease. Not indicated for use in patients who are homozygotes. Not to be initiated in patients receiving ongoing anticoagulant therapy. Confirm presence of amyloid β pathology prior to initiating treatment. Amyloid related imaging abnormalities (ARIA). Patients w/ factors that indicate increased risk for intracerebral haemorrhage; history of transient ischemic attacks, stroke or seizures w/in 12 mth of screening; immunologic disorders who were not adequately controlled or required therapy w/ Ig, systemic monoclonal Ab, systemic immunosuppressants or plasmapheresis; autosomal dominant Alzheimer's disease or w/ Down syndrome. Perform ApoE ε4 status testing prior to treatment initiation; baseline brain MRI & periodic monitoring w/ MRI; cognitive function testing & clinical symptom assessment every 6 mth. Enhanced clinical vigilance for ARIA during 1st 14 wk of treatment; in patients w/ asymptomatic radiographic findings of ARIA-E. Higher incidence of ARIA, including symptomatic serious & recurrent ARIA in patients who are ApoE ε4 homozygote carriers. Intracerebral haemorrhage >1 cm in diameter including fatal events in patients taking concomitant anticoagulants or thrombolytic agents (eg, tissue plasminogen activator). Contains polysorbate which may cause allergic reactions. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception during treatment & for 2 mth after the last dose. Verify pregnancy status prior to initiating treatment. Not recommended during pregnancy. Lactation. No relevant use in paed.

Headache, ARIA, ARIA-H, cerebral microhaemorrhage ≤10; infusion-related reactions. Hypersensitivity (including delayed) reactions; symptomatic ARIA-H, cerebral microhaemorrhage >10, superficial siderosis, ARIA-E/symptomatic ARIA-E; atrial fibrillation; nausea.

Increased risk of intracerebral haemorrhage w/ anticoagulant therapy or thrombolytic agents.

Neurodegenerative Disease Drugs

N06DX04 - lecanemab ; Belongs to the class of other anti-dementia drugs.

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