On December 30, 2025, the FDA updated the label for Kisunla (donanemab) to incorporate a Boxed Warning. This significant label revision addresses the risk of Amyloid Related Imaging Abnormalities (ARIA), specifically ARIA with edema (ARIA-E), which can occur with monoclonal antibodies targeting aggregated forms of beta amyloid, including Kisunla.
Background
Kisunla (donanemab), also known as donanemab-azbt, is a therapeutic monoclonal antibody. The updated label now explicitly states that monoclonal antibodies directed against aggregated forms of beta amyloid, such as Kisunla, are associated with the risk of developing amyloid related imaging abnormalities (ARIA). These abnormalities are further characterized into ARIA with edema (ARIA-E) and ARIA with hemorrhage (ARIA-H), though the provided summary specifically mentions ARIA-E.
What this means
The inclusion of a Boxed Warning on the Kisunla label signifies a critical safety update for healthcare professionals and patients. This warning emphasizes the potential for serious adverse events, specifically amyloid related imaging abnormalities (ARIA), which include ARIA with edema (ARIA-E). Clinicians prescribing Kisunla must be vigilant in monitoring patients for signs and symptoms of ARIA, and should be prepared to manage these events according to established guidelines. The presence of a Boxed Warning typically indicates that the FDA considers the associated risk to be serious or potentially life-threatening, requiring careful consideration in treatment decisions and patient counseling. This label change ensures that the most prominent safety information is readily available to all users of the drug.
Source
The information regarding this label revision for Kisunla (donanemab) was issued by the FDA. The updated label, which includes the Boxed Warning, became effective on December 30, 2025, and is accessible via the DailyMed database hosted by the National Library of Medicine at dailymed.nlm.nih.gov.