Active Ingredient: Lecanemab
Lecanemab is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 10 milligrams lecanemab per kilogram of body weight, once every 2 weeks.
The recommended dosage of lecanemab is 10 mg/kg that must be diluted then administered as an intravenous infusion over approximately one hour, once every two weeks.
If an infusion is missed, administer the next dose as soon as possible.
Lecanemab can cause amyloid related imaging abnormalities -edema (ARIA-E) and -hemosiderin deposition (ARIA-H).
Obtain a recent baseline brain magnetic resonance imaging (MRI) prior to initiating treatment with lecanemab. Obtain an MRI prior to the 5th, 7th, and 14th infusions. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including an MRI if indicated.
ARIA-E:
The recommendations for dosing interruptions for patients with ARIA-E are provided in Table 1.
Table 1. Dosing recommendations for patients with ARIA-E:
| Clinical Symptom Severity1 | ARIA-E Severity on MRI | ||
|---|---|---|---|
| Mild | Moderate | Severe | |
| Asymptomatic | May continue dosing | Suspend dosing3 | Suspend dosing3 |
| Mild | May continue dosing based on clinical judgment | Suspend dosing3 | |
| Moderate or Severe | Suspend dosing3 | ||
1 Clinical Symptom Severity Categories:
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.
3 Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; consider a follow-up MRI to assess for resolution 2 to 4 months after initial identification. Resumption of dosing should be guided by clinical judgment.
ARIA-H:
The recommendations for dosing interruptions for patients with ARIA-H are provided in Table 2.
Table 2. Dosing recommendations for patients with ARIA-H:
| Clinical Symptom Severity | ARIA-H Severity on MRI | ||
|---|---|---|---|
| Mild | Moderate | Severe | |
| Asymptomatic | May continue dosing | Suspend dosing 2 | Suspend dosing3 |
| Symptomatic | Suspend dosing 2 | Suspend dosing 2 | |
2 Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve; resumption of dosing should be guided by clinical judgment; consider a follow-up MRI to assess for stabilization 2 to 4 months after initial identification.
3 Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve; use clinical judgment in considering whether to continue treatment or permanently discontinue lecanemab.
In patients who develop intracerebral hemorrhage greater than 1 cm in diameter during treatment with lecanemab, 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 lecanemab.
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