Lecanemab Application Scope

Lecanemab, marketed as LEQEMBI™, is a monoclonal antibody designed to target aggregated forms of amyloid beta, implicated in Alzheimer’s disease pathology.

It received accelerated approval from the U.S. FDA in January 2023 for treating Alzheimer’s disease, specifically in patients with mild cognitive impairment or mild dementia stages.

lecanemab-irmb

Lecanemab Package Insert

Ingredients: Each vial contains lecanemab-irmb as the active ingredient. Inactive components include arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polysorbate 80, and water for injection.
Properties: Lecanemab is a humanized IgG1 monoclonal antibody targeting aggregated soluble and insoluble amyloid beta forms, reducing amyloid beta plaques in the brain.
Specification: Available as a solution for intravenous infusion, with concentrations of 200 mg/2 mL and 500 mg/5 mL per single-dose vial.
Packaging Specification: Supplied in single-dose vials containing either 200 mg/2 mL or 500 mg/5 mL of solution.
Storage: Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Expiry Date: Refer to the specific vial’s labeling for expiration details.
Executive Standard: Approved under the accelerated approval pathway by the U.S. FDA approval.
Approval Number: FDA Biologics License Application (BLA) number 761269.
Date of Revision: January 2023.
Manufacturer: Eisai Co., Ltd.

Guidelines for the Use of Lecanemab

Dosage and Administration:
- Confirm the presence of amyloid beta pathology before initiating treatment.
- Administer 10 mg/kg intravenously every two weeks.
- Obtain brain MRIs prior to the 5th, 7th, and 14th infusions to monitor for amyloid-related imaging abnormalities (ARIA).
Lecanemab Side Effects:
- Common adverse reactions (≥10%) include infusion-related reactions, ARIA-edema (ARIA-E), ARIA-microhemorrhages (ARIA-H), and headache.
Contraindications:
- No specific contraindications are listed in the prescribing information. However, caution is advised in patients with conditions predisposing them to intracerebral hemorrhage.
Precautions:
- Monitor for ARIA with periodic MRIs during treatment.
- Discuss the risk of ARIA with patients prior to initiating therapy.
- Exercise caution in patients on anticoagulant therapy due to an increased risk of intracerebral hemorrhage.

Lecanemab Interactions

Drug Interactions:
- No formal drug-drug interaction studies have been conducted.
- Use caution when considering lecanemab in patients requiring anticoagulant or thrombolytic therapy due to an increased risk of intracerebral hemorrhage.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.