Leqembi Dosage/Direction for Use

Treatment should be initiated by a physician experienced in the diagnosis and treatment of Alzheimer's disease. The infusion of lecanemab should be initiated and supervised by a healthcare professional.
Patient selection: Confirm the presence of amyloid beta pathology prior to initiating treatment using a validated test (see Pharmacology: Pharmacodynamics under Actions).
Testing for apolipoprotein E4 status should be performed prior to initiation of treatment using a validated test. Prior to testing the prescribers should discuss with patients the risk of ARIA and should be appropriately counselled. Consider the benefit of LEQEMBI for the treatment of Alzheimer's disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with LEQEMBI.
Posology: The recommended dosage of LEQEMBI 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.
The duration of placebo-controlled efficacy data for lecanemab in the pivotal clinical study was 18 months (see Pharmacology: Pharmacodynamics under Actions). Data beyond 18 months is currently limited.
Monitoring and dosing interruption for amyloid related imaging abnormalities: LEQEMBI can cause amyloid related imaging abnormalities-edema (ARIA-E) and -hemosiderin deposition (ARIA-H) (see Precautions).
The benefit-risk of treatment should be reassessed at regular intervals on an individual basis. Consideration should be given to discontinuing treatment if lecanemab would no longer be expected to be effective.
Monitoring for ARIA: Obtain a recent baseline brain magnetic resonance imaging (MRI) prior to initiating treatment with LEQEMBI. Obtain an MRI prior to the 5^th, 7^th, and 14^th infusions. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including an MRI if indicated.
Recommendations for dosing interruptions in patients with ARIA: ARIA-E: The recommendations for dosing interruptions for patients with ARIA-E are provided in Table 4. (See Table 4.)

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ARIA-H: The recommendations for dosing interruptions for patients with ARIA-H are provided in Table 5. (See Table 5.)

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Following an initial event of ARIA, recurrence can occur in non-carriers, heterozygous and homozygous carriers with a higher risk in the latter.
Intracerebral haemorrhage: In patients who develop intracerebral haemorrhage greater than 1 cm in diameter during treatment with LEQEMBI, discontinue treatment.
Special populations: Geriatric population: No overall differences in safety or effectiveness of LEQEMBI have been observed between patients 65 years of age and older and younger adult patients.
Paediatric population: Safety and effectiveness of LEQEMBI in paediatric patients have not been established.
Method of administration: Dilution instructions: Prior to administration, LEQEMBI must be diluted in 250 mL of 0.9% Sodium Chloride Injection.
Use aseptic technique when preparing the LEQEMBI diluted solution for intravenous infusion.
Calculate the dose (mg), the total volume (mL) of LEQEMBI solution required, and the number of vials needed based on the patient's actual body weight and the recommended dose of 10 mg/kg. Each vial contains a LEQEMBI concentration of 100 mg/mL.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check that the LEQEMBI solution is clear to opalescent and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present.
Remove the flip-off cap from the vial. Insert the sterile syringe needle into the vial through the center of the rubber stopper.
Withdraw the required volume of LEQEMBI from the vial(s) and add to an infusion bag containing 250 mL of 0.9% Sodium Chloride Injection.
Each vial is for one-time use only. Discard any unused portion.
Gently invert the infusion bag containing the LEQEMBI diluted solution to mix completely. Do not shake.
After dilution, immediate use is recommended. If not administered immediately, store LEQEMBI refrigerated at 2°C to 8°C for up to 4 hours, or at room temperature up to 30°C for up to 4 hours. Do not freeze. (see Special precautions for storage under Storage).
Administration instructions: Visually inspect the LEQEMBI diluted solution for particles or discoloration prior to administration. Do not use if it is discolored, or opaque or foreign particles are seen.
Prior to infusion, allow the LEQEMBI diluted solution to warm to room temperature.
Infuse the entire volume of the LEQEMBI diluted solution intravenously over approximately one hour through an intravenous line containing a terminal low-protein binding 0.2 micron in-line filter. Flush infusion line to ensure all LEQEMBI is administered.
Monitor for any signs or symptoms of an infusion-related reaction. The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy administered as clinically indicated. Consider pre-medication at subsequent dosing with antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids (see Precautions).