Therapy initiation and treatment should only be carried out by a doctor with experience in the diagnosis and treatment of Alzheimer's dementia and the ability to carry out MRI examinations promptly.
Patients must be informed in detail about the treatment and informed about the risks and possible adverse effects. Patients receive a patient card, which they should carry with them at all times.
The infusion should only be carried out by appropriately trained personnel.
Recommended dose: 10 mg/kg body weight, as an intravenous (IV) infusion over a period of 1 hour once every 2 weeks; after the first application, monitor for 2.5 hours for signs of infusion-related reactions/adverse effects. Use as a diluted solution; for instructions on the preparation of the solution, see technical information.
Duration of therapy: as soon as progression to moderate Alzheimer's disease has occurred, treatment should be discontinued.
Course of therapy and monitoring: APO E genotyping must be performed prior to initiation of therapy using standardized, validated certified in-vitro tests. The APO E status must be available for the risk assessment of the occurrence of ARIA (Amyloid Related Imaging Abnormalities) as an expression of serious side effects of therapy with lecanemab (separate patient information and consent to the test must be observed!).
Cognitive progression: approximately every 6 months review of cognitive function and assessment of clinical symptoms to assess the course of the disease or the presence of progression to assess the effectiveness of the therapy and decide whether to continue or discontinue therapy.
Monitoring for amyloid-related imaging abnormalities (ARIA), which can also lead to discontinuation of therapy:
As a basis for radiological assessment, a baseline brain MRI must be available before the start of treatment (not older than 6 months) and a brain MRI must be performed before the 5th/7th and 14th infusion.
ARIA with edema (ARIA-E): recognizable on MRI as cerebral edema or fluid accumulation in the sulci area.
ARIA with hemosiderin deposition (ARIA-H): recognizable as microbleeds and superficial siderosis.
In addition to ARIA, intracerebral hemorrhages with a diameter of more than 1 cm may occur during treatment with lecanemab. These always lead to the definitive, permanent discontinuation of therapy!
The extent and severity of ARIA is assessed on the basis of clinical and radiological findings and, in addition to the cognitive findings, is the most important basis for deciding whether to continue, interrupt or discontinue treatment. For recommendations on the classification of ARIA with regard to the decision to interrupt or discontinue treatment, see also the introductory information.
Delayed or missed dose: in case of a missed infusion, the next dose should be administered as soon as possible.
Special patient groups: no dose adjustment required in elderly patients (≥65 yrs); mild to moderate renal impairment; mild to moderate hepatic impairment. The drug has no relevance in children and adolescents.
For better monitoring of safety and efficacy, treatment is recorded in a central registry system.
For traceability, the name of the medicinal product and the batch number of the medicinal product used must be clearly documented.