Eisai GmbH, in agreement with the European Medicines Agency (EMA), has updated the MRI monitoring schedule for LEQEMBI (lecanemab) 100 mg/mL concentrate for infusion, a treatment for early Alzheimer’s disease. The change introduces an additional MRI scan prior to the third infusion to help detect and manage potential side effects earlier in treatment.
Previously, MRI scans were recommended before treatment initiation and prior to the 5th, 7th, and 14th infusions. Following new safety data, the SmPC (Summary of Product Characteristics) now requires an additional MRI before the 3rd infusion.
This adjustment aims to identify asymptomatic amyloid-related imaging abnormalities (ARIA) earlier and reduce the risk of serious or fatal ARIA-E events, which have been reported in post-marketing data from outside the EU.
LEQEMBI is indicated for adult patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease, who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology.
The therapy can cause amyloid-related imaging abnormalities, which are often asymptomatic but can sometimes lead to severe or life-threatening complications. ARIA typically occurs during the early treatment phase, highlighting the importance of enhanced clinical vigilance during the first 14 weeks.
Healthcare professionals are advised to perform the MRI within one week before the scheduled infusion and to review the results before proceeding.
If ARIA-E is detected, clinicians may suspend or discontinue treatment based on clinical judgment. Updated educational materials including the HCP guide and patient card — now reflect this new monitoring schedule.
Additionally, a Controlled Access Program remains in place to ensure LEQEMBI is prescribed only to appropriately indicated patients, reinforcing the safe and responsible use of the medication.
Healthcare professionals are encouraged to report any suspected adverse reactions via national reporting systems to support ongoing safety monitoring.
Learn more: EuropaLeqembi - direct healthcare professional communication (DHPC) | European Medicines Agency (EMA)
