LEQEMBI

/ Eisai Israel Ltd

The recommended dosage is 10 mg/kg that must be diluted then administered as an intravenous infusion over approximately one hour, once every two weeks.
Monitoring for ARIA
Obtain a recent baseline brain magnetic resonance imaging (MRI) prior to initiating treatment. Obtain an MRI prior to the 3rd, 5th, 7th, and 14th infusions. In general, the MRI should be performed within approximately one week before the scheduled infusion of lecanemab and reviewed prior to proceeding with the infusion. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including an MRI if indicated.

Treatment of Alzheimer’s disease. Treatment 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.

Hypersensitivity to lecanemab or to any of the excipients

Amyloid Related Imaging Abnormalities
Monoclonal antibodies directed against aggregated forms of beta amyloid, can cause amyloid related imaging abnormalities (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 can occur spontaneously in patients with Alzheimer’s disease, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy, such as pretreatment microhemorrhage or superficial siderosis. ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta amyloid generally occurs in association with an occurrence of ARIAE.
ARIA-H of any cause and ARIA-E can occur together.
ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal. When present, 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. In addition to ARIA, intracerebral hemorrhages greater than 1 cm in diameter have occurred.
Hypersensitivity Reactions
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction, and initiate appropriate therapy.
Infusion-Related Reactions
Infusion-related reactions were more common in patients treated with lecanemab than in those receiving placebo; and the majority occurred with the first infusion. Infusion-related reactions were mostly mild or moderate in severity. Symptoms of infusion-related reactions include fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation. Transient decreased lymphocyte counts to less than 0.9 x109/L compared to placebo, and patients treated with lecanemab had transient increased neutrophil counts to greater 7.9 x109/L compared to placebo. Lymphocyte and neutrophil counts were not obtained after the first infusion.
See prescribing information for full details.

Adverse reactions that were reported in at least 5% of patients: Infusion-related reactions, Headache, ARIA-E, ARIA-H, Cough, Diarrhea, Superficial siderosis of central nervous system, Rash, Nausea/Vomiting.
See prescribing information for full details.

Pregnancy: There are no adequate data on lecanemab use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Lactation: There are no data on the presence of lecanemab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Published data from other monoclonal antibodies generally indicate low passage of monoclonal antibodies into human milk and limited systemic exposure in the breastfed infant. The effects of this limited exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lecanemab and any potential adverse effects on the breastfed infant from lecanemab or from the underlying maternal condition.