Lecanemab

Lecanemab is a prescription medication indicated for the treatment of Alzheimer’s disease. Treatment with lecanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

• Lecanemab is available under the following different brand names: Leqembi, lecanemab-irmb

Common side effects of Lecanemab include:

• infusion-related reactions
• amyloid related imaging abnormality-microhemorrhages 
• amyloid related imaging abnormality-edema (ARIA-E)
• headache

Serious side effects of Lecanemab include:

• amyloid related imaging abnormalities or ARIA
• symptoms of serious allergic reactions may include swelling of the face, lips, mouth, or tongue, hives, or difficulty breathing
• symptoms of infusion-related reactions may include fever, flu-like symptoms, nausea, vomiting, dizziness or lightheadedness, changes in the heart rate or feel like the chest is pounding, difficulty breathing or shortness of breath

Rare side effects of Lecanemab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

 Adult dosage

Injectable, IV solution

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

injection, SC solution

• 360 mg/1.8 mL (200 mg/mL) prefilled autoinjector

Alzheimer's Disease

Adult dosage

• Starting dose: 10 mg/kg IV every 2 weeks
• Maintenance dose
  • After 18 months, may transition to maintenance dosing
  • IV: Continue 10 mg/kg IV every 2 Weeks or transition to a maintenance regimen of 10 mg/kg IV every 4 Weeks
• SC: 360 SC once weekly
• Switching between maintenance dose regimens
• During maintenance dosage regimen, patients may switch route of administration (ie, IV or SC)
• Transition should be initiated at 1 week following the last maintenance dose of either IV or SC regimen
• Thereafter, follow the dosing schedule for the newly assigned maintenance dosage regimen
• 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 the 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 activities

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 an intracerebral hemorrhage above 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 Considerations – Should be Given as Follows: 

• See “Dosages”

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lecanemab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lecanemab?”

Cautions

• Hypersensitivity reactions
  • Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have been reported
  • If being administered IV, promptly discontinue upon first observation of any signs or symptoms consistent with hypersensitivity reaction and initiate appropriate therapy
• Infusion-related reactions
  • Infusion-related reactions were observed; a majority of these reactions occurred with the 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's disease, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy (eg, pretreatment microhemorrhage, superficial siderosis)
  • ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta-amyloid generally occurs in association with the 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, can rarely occur
  • ARIA can be fatal; 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
• Intracerebral hemorrhage
  • Rare reports of intracerebral hemorrhage above 1 cm in diameter
  • Fatal events of intracerebral hemorrhage in patients taking Lecanemab observed
• Risk factors for ARIA and intracerebral hemorrhage
  • Risk of ARIA, including symptomatic and serious ARIA, is increased in (ApoE ε4) homozygotes
• Concomitant antithrombotic medication
  • Patients taking Lecanemab with an anticoagulant alone or combined with an antiplatelet medication or aspirin had a higher incidence of intracerebral hemorrhage
  • Exercise additional caution when considering administering anticoagulants or thrombolytics (eg, tissue plasminogen activator) to patients already being treated with Lecanemab
• 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
  • Providers should encourage patients to participate in real-world data collection (eg, registries) to help further understanding of Alzheimer's disease and the impact of treatments; providers and patients can contact Eisai at 888-274-2378 for a list of currently enrolling programs
• Radiographic findings of cerebral amyloid angiopathy (CAA)
  • Neuroimaging findings that may indicate CAA include evidence of prior intracerebral hemorrhage, cerebral microhemorrhage, and cortical superficial siderosis
  • CAA increases risk for intracerebral hemorrhage
  • Presence of an ApoE ε4 allele is also associated with cerebral amyloid angiopathy
• Concomitant antithrombotic or thrombolytic medication
  • Fatal cerebral hemorrhage has occurred in a patient taking an anti-amyloid monoclonal antibody in the setting of focal neurologic symptoms of ARIA and use of a thrombolytic agent
  • Additional caution should be exercised when considering the administration of an antithrombotic or a thrombolytic agent (.eg, tissue plasminogen activator) to a patient already being treated with this drug
  • Exercise caution when considering use in patients with factors that indicate an increased risk for intracerebral hemorrhage, and for patients who need to be on anticoagulant therapy, or patients with findings on MRI that are suggestive of cerebral amyloid angiopathy

Pregnancy and Lactation

• 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 the presence in human milk, its effects on breastfed infants, or its effects on milk production
  • Published data from other monoclonal antibodies generally indicate the low passage of monoclonal antibodies into human milk and limited systemic exposure in breastfed infants
  • The effects of this limited exposure are unknown