IntravenousAlzheimer's diseaseAdult: In patients with mild cognitive impairment and mild dementia stage who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers: 10 mg/kg once every 2 weeks. Alternative dose recommendation: Initially, 10 mg/kg once every 2 weeks for 18 months. Maintenance dose: 10 mg/kg once every 2 weeks or 10 mg/kg once every 4 weeks after 18 months. All doses are given via infusion over approx 1 hour. Discontinue treatment once the patient progresses to moderate Alzheimer's disease. Dosing interruption or discontinuation may be required according to individual safety and tolerability. Dosage recommendations may vary between countries (refer to local product guidelines).
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Pharmacogenomics:
Lecanemab is a monoclonal antibody directed against aggregated forms of amyloid β. It can cause amyloid-related imaging abnormalities (ARIA), including ARIA with oedema (ARIA-E) and ARIA with haemosiderin deposition (ARIA-H). Studies show that apolipoprotein E ε4 (ApoE ε4) increases the risk of developing Alzheimer's disease and plays a role in disease progression.
Approx 15% of individuals with Alzheimer's disease are ApoE ε4 homozygotes. Individuals carrying the ApoE ε4 homozygote genotype have an increased risk of developing ARIA (including symptomatic, serious, severe radiographic and recurrent ARIA) and cerebral amyloid angiopathy compared to ApoE ε4 heterozygotes and non-carriers. The US Food and Drug Administration (US FDA) recommends ApoE ε4 genotyping prior to treatment initiation with Lecanemab.
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Withdraw the required volume from the vial labelled as containing 100 mg/mL and add to 250 mL NaCl 0.9% solution for inj. Gently invert the infusion bag to mix. Do not shake.
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Hypersensitivity. MRI findings of prior intracerebral haemorrhage, >4 microhaemorrhages, or superficial siderosis or vasogenic oedema suggestive of cerebral amyloid angiopathy.
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Patient with a history of TIA, stroke, or seizures (within 12 months); risk factors for intracerebral haemorrhage; bleeding disorder; Down syndrome. Not indicated for use in patients who are ApoE ε4 homozygotes. Concomitant use with anticoagulants and thrombolytic agents. Pregnancy and lactation.
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Significant: Hypersensitivity reactions (e.g. angioedema, bronchospasm, anaphylaxis); infusion-related reactions (e.g. fever, chills, generalised aches, shakiness, joint pain, nausea, vomiting, hypotension, hypertension, oxygen desaturation).
Cardiac disorders: Atrial fibrillation.
Gastrointestinal disorders: Diarrhoea.
Nervous system disorders: Headache, superficial siderosis of CNS.
Respiratory, thoracic and mediastinal disorders: Cough.
Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Amyloid-related imaging abnormalities (ARIA) characterised as ARIA with oedema (ARIA-E) and ARIA with haemosiderin deposition (ARIA-H); intracerebral haemorrhage.
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Confirm the presence of amyloid β pathology using positron emission tomography (PET) scan or lumbar puncture before initiation of treatment. Perform ApoE ε4 status test prior to treatment initiation. Obtain brain MRI scan at baseline, before the 5th, 7th, and 14th infusions, and periodically as clinically appropriate. Closely monitor for clinical and MRI changes. Assess for signs and symptoms suggestive of ARIA (e.g. headache, visual changes, altered mental status, gait difficulty, focal neurologic deficits, seizures); hypersensitivity and infusion-related reactions.
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Potentially Fatal: Increased risk of intracerebral haemorrhage with anticoagulants and thrombolytic agents.
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Description:
Mechanism of Action: Lecanemab is a recombinant humanised immunoglobulin G1 (IgG1) monoclonal antibody that binds to soluble and insoluble amyloid β aggregates, thereby reducing amyloid β plaques in the brain. The accumulation of these plaques is the defining pathophysiological attribute of Alzheimer's disease.
Pharmacokinetics:
Metabolism: Undergoes degradation by proteolytic enzymes.
Excretion: Elimination half-life: 5-7 days.
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Intact vial: Store between 2-8°C. Diluted solution: Store between 2-8°C for up to 4 hours or store at room temperature (up to 25°C) for up to 4 hours. Do not freeze. Protect from light.
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N06DX04 - lecanemab ; Belongs to the class of other anti-dementia drugs.
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Annotation of FDA Label for Lecanemab and APOE. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org. Accessed 03/03/2025. APOE - Lecanemab. UpToDate Lexidrug, Pharmacogenomics Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/03/2025. Joint Formulary Committee. Lecanemab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/03/2025. Lecanemab. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/03/2025. Lecanemab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/03/2025. Leqembi (Eisai [Hong Kong] Co Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 19/03/2025. Leqembi 100 mg/mL Concentrate for Solution for Infusion (Eisai Europe Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/03/2025. Leqembi Injection, Solution (Eisai Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/03/2025.
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