General

Pronunciation:
lek-an-e-mab

Trade Name(s)

• Leqembi

Ther. Class.

anti-Alzheimers's agents

Pharm. Class.

monoclonal antibodies

anti amyloid monoclonal antibodies

Indications

Alzheimer's disease (with mild cognitive impairment or mild dementia).

Action

Acts as a monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.

Therapeutic Effect(s):

• Reduction in clinical decline.
• Reduction in amyloid beta plaques in the brain.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Not widely distributed to extravascular tissues.

Metabolism and Excretion: Degraded into small peptides and amino acids via catabolic pathways.

Half-life: 5–7 days.

TIME/ACTION PROFILE (plasma concentrations)

Contraindication/Precautions

Contraindicated in:

• Previous localized superficial siderosis, >4 brain microhemorrhages, and/or brain hemorrhage (↑ risk of intracerebral hemorrhage).

Use Cautiously in:

• OB:   Safety not established in pregnancy;
• Lactation:  Safety not established in breastfeeding;
• Pedi:   Safety and effectiveness not established in children.

Adverse Reactions/Side Effects

CV: atrial fibrillation

GI: diarrhea

Hemat: lymphopenia

Neuro: amyloid-related imaging abnormalities (including edema and hemosiderin deposition), headache, SEIZURES

Resp: cough

Misc: infusion-related reactions

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

 Antithrombotic drugs  and  thrombolytics  may ↑ risk of intracerebral hemorrhage.

Route/Dosage

IV (Adults): 10 mg/kg every 2 wk.

Availability

Solution for injection: 100 mg/mL

Assessment

• Baseline brain MRI and periodic monitoring with MRI are recommended. Enhanced clinical vigilance for ARIA is recommended during the first 14 wks of therapy.
• May cause amyloid related imaging abnormalities -edema (ARIA-E) and -hemosiderin deposition (ARIA-H). For patients with ARIA-E severity on MRI:  If asymptomatic and mild severity,  continue dosing.  If asymptomatic and moderate or severe severity,  suspend dosing.  If symptoms are mild (discomfort noticed, but no disruption of normal daily activity) with mild severity,  May continue dosing based on clinical judgment.  If symptoms are mild with moderate or severe severity,  suspend dosing.  If symptoms are moderate (discomfort sufficient to reduce or affect normal daily activity) or severe (incapacitating, with inability to work or to perform normal daily activity),  suspend dosing. Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; consider a follow-up MRI to assess for resolution 2 to 4 mo after initial identification. Use clinical judgement when considering resumption of dosing.
• For patients with ARIA-H severity on MRI:  If asymptomatic and mild severity,  continue dosing.  If asymptomatic and moderate or severe severity,  suspend dosing.  If symptomatic,  suspend dosing.  For mild or moderate severity,  Suspend until MRI demonstrates radiographic stabilization and symptoms resolve; use clinical judgement regarding resumption of dosing; consider a follow-up MRI to assess for stabilization 2 to 4 months after initial identification.  For severe ARIA-H severity on MRI,  Suspend until MRI demonstrates radiographic stabilization and symptoms resolve; use clinical judgment in considering whether to continue or permanently discontinue therapy.
• If patient develops an intracerebral hemorrhage >1 cm in diameter during therapy, suspend dosing until MRI demonstrates radiographic stabilization and symptoms resolve. Use clinical judgment in considering whether to continue or permanently discontinue therapy.
• Monitor for any signs or symptoms of an infusion-related reaction (fever and flu-like symptoms [chills, generalized aches, feeling shaky, and joint pain], nausea, vomiting, hypotension, hypertension, and oxygen desaturation) during therapy. The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy administered. Consider pre-medication at subsequent dosing with antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids.

Lab Test Considerations:

Confirm the presence of amyloid beta pathology before starting therapy.

Implementation

• Obtain a recent (within one year) brain magnetic resonance imaging (MRI) prior to starting therapy. Obtain an MRI prior to the 5th, 7th, and 14th infusions.
• Dilution:  Dilute in 250 mL of 0.9% NaCl. Solution is clear to opalescent and colorless to pale yellow; do not administer solution that are discolored, cloudy, or contain particulate matter. Gently invert to mix; do not shake. Solution is stable for 4 hr at room temperature or if refrigerated; do not freeze. Allow solution to warm to room temperature before infusing.
• Rate: Infuse over 1 hr through a terminal low-protein binding 0.2 micron in-line filter. Flush infusion line to ensure all medication is administered.

Patient/Family Teaching

• Explain purpose of lecanemab to patient and family. Advise patient and caregiver to read the  Medication Guide  before and periodically during therapy in case of changes. If an infusion is missed, schedule next infusion as soon as possible.
• Advise patient to notify health care professional if signs an symptoms of ARIA (headache, confusion, dizziness, vision changes, nausea, difficulty walking, seizures) or infusion-related reaction occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• 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  Leqembi. Encourage patients to participate in the ALZ-NET registry.
• Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Reduction in amyloid beta plaques in the brain.