Donanemab Resources for Health Care Professionals
Donanemab (Kisunla™) is an FDA-approved intravenous monoclonal antibody therapy targeting specific forms of amyloid-β plaque, indicated for early symptomatic Alzheimer’s disease (AD), mild cognitive impairment (MCI) or mild dementia due to AD, confirmed by amyloid biomarkers. This therapy offers a disease-modifying option that may slow clinical decline in eligible patients.
Given the complexity of administration and safety monitoring, the Alzheimer’s Association developed detailed Appropriate Use Recommendations (AUR) and system-level guidance to support clinicians in safely implementing donanemab treatment.
Background
Donanemab received FDA approval based on clinical trial evidence demonstrating its ability to target amyloid plaques and slow cognitive progression in early AD. The Alzheimer’s Disease and Related Disorders Therapeutics Workgroup created AURs to ensure real-world safe and effective use. This workgroup was established in 2022 to provide resources for clinicians about the benefits and risks of FDA-approved amyloid-targeting therapies for AD.
Donanemab treatment requires rigorous patient evaluation, including confirmation of amyloid pathology by PET or cerebrospinal fluid analysis, baseline MRI brain imaging to exclude high-risk cerebrovascular features and APOE genotyping for risk stratification related to amyloid-related imaging abnormalities (ARIA).
Effective use depends on multidisciplinary collaboration, comprehensive patient monitoring for infusion reactions and ARIA, and organizational readiness at the health system level, including infrastructure, workflows and communication protocols.
Donanemab Appropriate Use Recommendations for Health Care Providers
This summary document outlines critical guidance for clinicians treating patients with donanemab. It covers:
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Patient evaluation and eligibility, including clinical staging, biomarker confirmation and exclusion criteria.
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Necessary baseline assessments, such as brain MRI and APOE genotyping for ARIA risk stratification.
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Treatment administration protocols including dosing, infusion timing and management of infusion reactions. NOTE: As of July 2025, the FDA label includes an updated infusion schedule, which is different from the schedule recommended in the AUR.
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Monitoring schedules for amyloid-related imaging abnormalities and corresponding management pathways.
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Risk mitigation strategies and shared decision-making frameworks to ensure patient safety and informed consent.
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Clinicians should refer to this document for a structured approach to identifying candidates, initiating therapy and managing treatment-related risks.
Download Donanemab AUR Summary for Health Care Providers
When and How to Use the Appropriate Use Recommendations
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Begin with a thorough clinical evaluation and confirmatory testing for amyloid biomarkers.
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Obtain baseline MRI and APOE genotype; discuss risks and benefits thoroughly with patients and care partners.
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Establish infusion and monitoring schedules per AUR guidelines, including ARIA surveillance.
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Monitor patients continuously for adverse events, adjusting treatment based on ARIA severity and clinical status.
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Ensure multidisciplinary coordination and clear communication pathways at the system level.
View the Donanemab Appropriate Use Recommendations
ALZ-NET and Donanemab Support
Clinicians prescribing donanemab are encouraged to participate in ALZ-NET, the only voluntary health care provider-enrolled network in the United States collecting clinical, imaging and safety data for patients being treated with FDA-approved Alzheimer’s disease therapies. By becoming an ALZ-NET site, your practice contributes to the growing body of RWE that informs treatment decisions, supports patient care and advances Alzheimer’s research.
Update July 2025
The FDA-approved label for donanemab (Kisunla™) now includes an updated titration and infusion schedule, which differs from the dosing described in the current Appropriate Use Recommendations (AUR) that were published in early 2025. The AUR and supporting materials will be updated if and when revised guidance becomes available.
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