lecanemab (Rx)

Brand and Other Names:Leqembi, lecanemab-irmb
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable, IV solution

  • 200mg/2mL single-dose vial
  • 500mg/5mL single-dose vial
  • Must dilute before administration

Alzheimer Disease

Indicated for treatment of patients with Alzheimer disease who have mild cognitive impairment or mild dementia stage disease

10 mg/kg IV q2Weeks

Dose interruptions for amyloid-related imaging abnormalities

  • Can cause amyloid-related imaging abnormalities-edema (ARIA-E) and -hemosiderin deposition (ARIA-H)
  • Dose interruptions may be needed depending on clinical symptoms and MRI results

Classification of severity of symptoms

  • Mild: Discomfort noticed, but no disruption of normal daily activity
  • Moderate: Discomfort sufficient to reduce or affect normal daily activity
  • Severe: Incapacitating, with inability to work or to perform normal daily activity

ARIA-E dose interruptions

  • Clinically asymptomatic
    • Mild MRI: May continue dosing
    • Moderate/severe MRI: Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; consider follow-up MRI to assess for resolution 2-4 months after initial identification; guide dose resumption by clinical judgment
  • Clinically mild symptoms
    • Mild MRI: May continue dosing based on clinical judgment
    • Moderate/severe MRI: Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; consider follow-up MRI to assess for resolution 2-4 months after initial identification; guide dose resumption by clinical judgment
  • Clinically moderate/severe symptoms
    • Mild, moderate, or severe MRI: Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; consider follow-up MRI to assess for resolution 2-4 months after initial identification; guide dose resumption by clinical judgment

ARIA-H dose interruptions

  • Clinically asymptomatic
    • Mild MRI: May continue dosing
    • Moderate MRI: Suspend dosing
    • Severe MRI: Suspend dosing
  • Clinically symptomatic
    • Mild or moderate MRI: Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve; resumption of dosing should be guided by clinical judgment; consider follow-up MRI to assess for stabilization 2-4 months after initial identification
    • Severe MRI: Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve; use clinical judgment in considering whether to continue treatment or permanently discontinue
    • In patients who develop intracerebral hemorrhage >1 cm in diameter during treatment, suspend dosing until MRI demonstrates radiographic stabilization and symptoms, if present, resolve; use clinical judgment in considering whether to continue treatment after radiographic stabilization and resolution of symptoms or permanently discontinue

Dosage Modifications

Renal or hepatic impairment

  • No clinical studies were conducted to evaluate the pharmacokinetics in patients with renal or hepatic impairment

Dosing Considerations

Patient selection

  • Confirm presence of amyloid beta pathology before initiating
  • Initiate in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials
  • There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied

Monitoring for ARIA

  • Obtain a recent (within 1 year) brain MRI before initiating
  • Also, obtain an MRI before the 5th, 7th, and 14th infusions

Not indicated

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Adverse Effects

>10%

Infusion-related reactions (20%)

Headache (14%)

1-10%

ARIA-E (10%)

Cough (9%)

Diarrhea (8%)

Atrial fibrillation (4%)

Lymphopenia (4%)

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Warnings

Contraindications

None

Cautions

Infusion-related reactions

  • Infusion-related reactions observed; majority of these reactions occurred with first infusion
  • Symptoms may include fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation
  • Monitor for any signs or symptoms of an infusion-related reaction; infusion rate may be reduced, or may be discontinued, and appropriate therapy administered as clinically indicated
  • Consider premedication at subsequent dosing with antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids

Amyloid related imaging abnormalities (ARIA)

  • Monoclonal antibodies directed against aggregated forms of beta amyloid can cause ARIA, characterized as ARIA with edema (ARIA-E), which can be observed on MRI as brain edema or sulcal effusions, and ARIA with hemosiderin deposition (ARIA-H), which includes microhemorrhage and superficial siderosis
  • ARIA-H can occur spontaneously in patients with Alzheimer disease
  • ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta amyloid generally occurs in association with an occurrence of ARIA-E
  • ARIA-H of any cause and ARIA-E can occur together
  • ARIA is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, rarely can occur
  • Reported symptoms associated with ARIA may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty; focal neurologic deficits may also occur; symptoms associated with ARIA usually resolve over time
  • See Dosing & Uses for monitoring and dosing interruption recommendations if ARIA-E or ARIA-H occurs
  • Information for patients and caregivers
    • Inform patients that although ARIA can occur in any patient treated with this medication, there is an increased risk in patients who are ApoE ε4 homozygotes, and that there is a test available to determine ApoE ε4 genotype
    • Advise patients that the Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) is a voluntary provider-enrolled patient registry that collects information on treatments for Alzheimer’s disease, including this medication; encourage patients to participate in the ALZ-NET registry
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Pregnancy & Lactation

Pregnancy

There are no adequate data regarding use in pregnant females to evaluate for drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

No animal studies have been conducted to assess potential reproductive or developmental toxicity

Lactation

There are no data regarding presence in human milk, effects on breastfed infants, or effects on milk production

Published data from other monoclonal antibodies generally indicate low passage of monoclonal antibodies into human milk and limited systemic exposure in breastfed infants

Effects of this limited exposure are unknown

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta

Accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer disease; lecanemab reduces amyloid beta plaques

Absorption

Steady-state reached: 6 weeks

Distribution

Vd: 3.22 L

Metabolism

Degraded by proteolytic enzymes in the same manner as endogenous IgGs

Elimination

Half-life: 5-7 days

Clearance: 0.434 L/day

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Administration

IV Compatibilities

0.9% NaCl

IV Preparation

Dose must be diluted in 250 mL of 0.9% NaCl before administration

Calculate dose (mg), total volume (mL) of lecanemab solution required, and number of vials needed based on patient’s actual body weight

Inspect visually for particulate matter and discoloration before administration; solution should appear clear to opalescent and colorless to pale yellow; discard if opaque particles, discoloration, or other foreign particles are present

Each vial is for one time-use only; discard any unused portion after admixing

Gently invert infusion bag containing of diluted solution to mix completely

Do not shake

IV Administration

Before infusion, allow prepared diluted solution to warm to room temperature

Infuse entire dose IV over ~1 hr through IV line containing a terminal low-protein binding 0.2-micron inline filter

Flush infusion line to ensure entire dose is administered

Monitor for any signs or symptoms of an infusion-related reaction; infusion rate may be reduced, or may be discontinued, and appropriate therapy administered as clinically indicated

Consider premedication at subsequent dosing with antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids

Missed dose: If infusion missed, administer next dose as soon as possible

Storage

Unopened vials

  • Refrigerate at 2-8ºC (36-46ºF)
  • Store in original carton to protect from light
  • Do not freeze or shake

Diluted solution

  • If not administered immediately, refrigerate at 2-8ºC (36-46ºF) for up to 4 hr, OR
  • Store at room temperature up to 30ºC (86ºF) for up to 4 hr
  • Do not freeze
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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.