Leqembi Lecanemab Injection

1. Indications and Usage
Alzheimer’s Disease:
Indicated for the treatment of mild cognitive impairment (MCI) or mild dementia stage of Alzheimer’s disease.
Patient Selection:
Treatment should be initiated in patients with mild cognitive impairment or mild dementia. The presence of amyloid beta (Aβ) pathology must be confirmed prior to starting treatment.
2. Dosage and Administration
Recommended Dosage:
Adults: 10 mg/kg administered intravenously every 2 weeks.
Administration Instructions:
Preparation: Must be diluted prior to use in 250 mL of 0.9% Sodium Chloride Injection. Gently invert to mix; do not shake.
Infusion: Administer via intravenous infusion over approximately 1 hour using an intravenous line with a 0.2-micron in-line filter.
Storage of Diluted Solution: If not used immediately, store at 2°C to 8°C or at room temperature (up to 30°C) for a maximum of 4 hours. Do not freeze.
Dose Modifications & Monitoring:
Missed Dose: If a dose is missed, administer the next dose as soon as possible.
MRI Monitoring: Obtain a baseline brain MRI prior to initiating treatment. Perform additional MRIs prior to the 5th, 7th, and 14th infusions.
Infusion-Related Reactions (IRRs): Monitor patients during infusion. If an IRR occurs, reduce the infusion rate or stop the infusion and provide appropriate medical care.
3. Mechanism of Action
Anti-Amyloid Beta Monoclonal Antibody:
Lecanemab is a recombinant humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody.
Physiological Effect:
It selectively targets and binds to large, soluble amyloid beta (Aβ) protofibrils (aggregated forms of Aβ). By neutralizing and clearing these neurotoxic Aβ aggregates and plaques from the brain, it reduces amyloid pathology associated with Alzheimer’s disease.
4. Safety and Warnings
Amyloid Related Imaging Abnormalities (ARIA):
ARIA-E (edema/effusion) and ARIA-H (microhemorrhages and superficial siderosis) can occur. Most cases are asymptomatic, but serious and potentially fatal events have occurred. The risk of ARIA is significantly increased in patients who are Apolipoprotein E (ApoE) ε4 homozygotes.
Infusion-Related Reactions (IRRs):
Symptoms may include fever, chills, body aches, nausea, vomiting, hypotension, hypertension, and dyspnea. Monitor patients closely during administration.
Hypersensitivity Reactions:
Angioedema and anaphylaxis have been reported. Discontinue lecanemab immediately if a serious hypersensitivity reaction occurs.
5. Adverse Reactions
Most Common:
Infusion-related reactions, ARIA-E (edema), ARIA-H (microhemorrhages), headache, and falls.
6. Drug Interactions
Anticoagulants and Antiplatelet Agents:
No formal drug interaction studies have been conducted. However, because ARIA-H involves microhemorrhages, caution is advised when administering lecanemab to patients receiving anticoagulant or antiplatelet therapy.
7. Pharmaceutical Information
Chemical Description:
Lecanemab is a humanized IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. It has a molecular weight of approximately 150 kDa.
Storage and Handling:
Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Do not freeze or shake.
Each single-dose vial is for one-time use only; discard any unused portion.