Leqembi Dosage/Direction for Use

Treatment should be initiated and supervised by physicians experienced in the diagnosis and treatment of Alzheimer's disease with timely access to Magnetic Resonance Imaging (MRI). Lecanemab infusions should be administered by qualified healthcare professionals trained to monitor for, recognize and manage infusion-related reactions.
Patients treated with lecanemab must be given the patient card and be informed about the risks of lecanemab.
ApoE4 Testing: ApoE4 genotype should be assessed by a CE-marked in vitro diagnostic (IVD) with the corresponding intended purpose. If the CE-marked IVD is not available, an alternative validated test should be used (see Pharmacology: Pharmacodynamics under Actions).
Testing for ApoE ε4 status should be performed prior to initiation of treatment with lecanemab to inform the risk of developing ARIA (see Indications/Uses and Pharmacology: Pharmacodynamics under Actions). Prior to testing patients should be appropriately counselled and consented according to national or local guidelines, as applicable.
Posology: The recommended dose of lecanemab is 10 mg/kg body weight administered as an intravenous (IV) infusion once every 2 weeks.
Treatment with lecanemab should be discontinued once the patient progresses to moderate Alzheimer's disease.
During treatment with lecanemab, cognitive function testing and clinical symptom assessment should occur approximately every 6 months. The cognitive testing and symptom progression should be used to assess whether the patient has progressed to moderate Alzheimer's dementia, and/or if the clinical course otherwise suggests that lecanemab has not demonstrated effectiveness in the patient, and inform the decision as to whether treatment with lecanemab should be discontinued.
Monitoring for Amyloid Related Imaging Abnormalities (ARIA): Lecanemab can cause ARIA, characterized as ARIA with oedema (ARIA-E), which can be observed on MRI as brain oedema or sulcal effusions, and ARIA with haemosiderin deposition (ARIA-H), which includes microhaemorrhage and superficial siderosis. In addition to ARIA, intracerebral haemorrhages greater than 1 cm in diameter have occurred in patients treated with lecanemab.
Obtain a recent (within 6 months) baseline brain MRI prior to initiating treatment with lecanemab to evaluate for pre-existing ARIA. Obtain an MRI prior to the 5^th, 7^th and 14^th infusions. If a patient experiences symptoms suggestive of ARIA at any time during treatment, clinical evaluation should be performed including an MRI (see Precautions).
Recommendations for Dosing Interruptions or Treatment Discontinuation in Patients with ARIA: ARIA-E: Dosing may continue in asymptomatic, mild radiographic ARIA-E cases. Suspend dosing for any symptomatic or radiographically moderate or severe ARIA-E. A follow-up MRI to assess for resolution 2 to 4 months after initial identification should be performed. Once the MRI demonstrates radiographic resolution and symptoms, if present, resolve, resumption of dosing should be guided by clinical judgment. See Table 2 for MRI radiographic severity (see Precautions).
Use clinical judgment in considering whether to continue dosing in patients with recurrent ARIA-E. After the second occurrence of symptomatic or radiographically moderate or severe ARIA-E, treatment with lecanemab should be discontinued (see Adverse Reactions).
ARIA-H: Dosing may continue in asymptomatic, mild radiographic ARIA-H cases. Suspend dosing for any symptomatic mild or moderate or radiographically moderate ARIA-H. A follow-up MRI to assess for stabilisation 2 to 4 months after initial identification should be performed. Once the MRI demonstrates radiographic stabilisation and symptoms, if present, resolve, resumption of dosing should be guided by clinical judgement (see Adverse Reactions). In the event of radiographically or symptomatic severe ARIA-H, treatment with lecanemab should be permanently discontinued. See Table 2 for MRI radiographic severity (see Precautions).
Intracerebral Haemorrhage: Lecanemab should be permanently discontinued if intracerebral haemorrhage greater than 1 cm in diameter occurs.
Delayed or missed doses: If an infusion is missed, the next dose should be administered as soon as possible.
Special populations: Elderly: No dose adjustment is necessary in patients ≥65 years (see Pharmacology: Pharmacodynamics under Actions).
Renal impairment: No specific dose adjustment is necessary in patients with mild to moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No specific dose adjustment is needed for patients with mild to moderate hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: There is no relevant use of lecanemab in the paediatric population.
Method of administration: Lecanemab is for intravenous use only. Lecanemab is administered as an intravenous infusion over approximately 1 hour once every 2 weeks. For the first infusion, the patient should be observed for approximately 2.5 hours following completion of the infusion for signs and symptoms of infusion-related reactions (see Precautions.)
Lecanemab is diluted prior to intravenous infusion.
For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.