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Kisunla ® (donanemab-azbt) injection, for intravenous infusion
350 mg/20 mL (17.5 mg/mL)
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
When should patients treated with Kisunla® (donanemab-azbt) receive MRIs for monitoring of ARIA?
Obtain brain MRI scan as a recent baseline prior to donanemab treatment initiation, before second, third, fourth, and seventh infusions, and if patients experience symptoms of ARIA.
See important safety information, including boxed warning, in the attached prescribing information.
Recommended MRI Schedule for Monitoring of Amyloid-Related Imaging Abnormalities
The donanemab prescribing information recommends
- enhanced clinical vigilance for amyloid-related imaging abnormalities (ARIA) during the first 24 weeks of treatment with donanemab, and
- baseline brain magnetic resonance imaging (MRI) and periodic monitoring with MRI.1
Obtain a recent brain MRI at baseline prior to treatment initiation with donanemab;1 the prescribing clinician should use clinical judgment to determine what constitutes a "recent" MRI. In the TRAILBLAZER-ALZ 2 study, the baseline MRI was performed within 49 days of treatment initiation.2
Obtain additional MRIs
- prior to the second, third, fourth, and seventh infusions, and
- if symptoms suggestive of ARIA occur.1
In clinical trials, the scheduled safety MRIs could occur up to 14 days before the next scheduled visit. The MRI prior to the 2nd infusion could not occur sooner than 21 days after the first infusion. Unscheduled MRIs may be performed as needed and at the discretion of investigator.2
The Alzheimer’s, ARIA, and Dementia Study Group of the American Society of Neuroradiology suggests that a baseline brain MRI conducted within 3 to 6 months before enrollment is ideal. However, an MRI done within the past 12 months may be acceptable if it shows no microhemorrhages. Patients with 1 to 4 microhemorrhages on a brain MRI taken 7 to 12 months before starting therapy should get a repeat MRI, as they have a high risk of more microhemorrhages.4
If donanemab dosing has been suspended, suspend dosing until
- MRI demonstrates radiographic resolution of amyloid-related imaging abnormalities-edema (ARIA-E) or radiographic stabilization of amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H), and
- symptoms resolve, if present.1
Consider a follow-up MRI to assess for resolution (ARIA-E) or stabilization (ARIA-H) 2 to 4 months after initial identification.1
For radiographically severe ARIA-H, suspend dosing until MRI demonstrates radiographic stabilization and symptoms, if present, resolve. Use clinical judgment when considering whether to continue treatment or permanently discontinue donanemab.1
Resumption of dosing should be guided by clinical judgement.1
MRI Sequences
Amyloid-related imaging abnormalities are best detected by
- fluid attenuation inversion recovery (FLAIR) sequences on MRI for ARIA-E, and
- T2* gradient-recalled echo or susceptibility weighted imaging sequences on MRI for ARIA-H.4-7
The Alzheimer’s, ARIA, and Dementia Study Group of the American Society of Neuroradiology advises using diffusion-weighted MRI to assess for acute ischemia and distinguish it from ARIA-E.4
ARIA Risk Management in TRAILBLAZER-ALZ 2
The TRAILBLAZER-ALZ 2 study managed ARIA risk by
- excluding patients with an MRI demonstrating preexisting ARIA-E, greater than 4 microhemorrhages, >1 area of superficial siderosis, any macrohemorrhage, or severe white matter disease
- employing a dose titration regimen that used an initial dose of donanemab 700 mg before increasing to 1400 mg
- conducting routine MRIs per protocol
- allowing unscheduled MRIs at the investigator's discretion, and
- providing information on dose modification, dose suspension, or supportive treatment in the event of incident ARIA.2
Severe white matter disease was consistent with a score of 3 in any of the brain regions rated on a modified age-related white matter changes (ARWMC) scale, across both hemispheres.8
Other Imaging Modalities for Identification of Amyloid-Related Imaging Abnormalities
In TRAILBLAZER-ALZ 2,
- MRI was used for ARIA detection and monitoring, and
- participants with contraindications to MRI were excluded.2
Due to the relatively low spatial definition and resolution of computed tomography (CT) in comparison with MRI, a CT scan
- would not be expected to detect milder forms of ARIA-E, and
- is insensitive to the detection of ARIA-H microhemorrhages and siderosis.6
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2Sims JR, Zimmer JA, Evans CD, et al; TRAILBLAZER-ALZ 2 Investigators. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. 2023;330(6):512-527. https://doi.org/10.1001/jama.2023.13239
3Mintun MA, Lo AC, Evans CD, et al. Donanemab in early Alzheimer’s disease. N Engl J Med. 2021;384(18):1691-1704. https://doi.org/10.1056/NEJMoa2100708
4Cogswell PM, Andrews TJ, Barakos JA, et al; ASNR Alzheimer’s, ARIA, and Dementia Study Group. Alzheimer's disease anti-amyloid immunotherapies: imaging recommendations and practice considerations for ARIA monitoring. AJNR Am J Neuroradiol. 2025;46(1):24-32. https://doi.org/10.3174/ajnr.A8469
5Sperling RA, Jack Jr CR, Black SE, et al. Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: recommendations from the Alzheimer’s Association Research Roundtable Workgroup. Alzheimers Dement. 2011;7(4):367-385. https://doi.org/10.1016/j.jalz.2011.05.2351
6Barakos J, Purcell D, Suhy J, et al. Detection and management of amyloid-related imaging abnormalities in patients with Alzheimer's disease treated with anti-amyloid beta therapy. J Prev Alzheimers Dis. 2022;9(2):211-220. https://doi.org/10.14283/jpad.2022.21
7Cogswell PM, Barakos JA, Barkhof F, et al. Amyloid-related imaging abnormalities with emerging Alzheimer disease therapeutics: detection and reporting recommendations for clinical practice. AJNR Am J Neuroradiol. 2022;43(9):E19-E35. https://doi.org/10.3174/ajnr.A7586
8Wahlund LO, Barkhof F, Fazekas F, et al. A new rating scale for age-related white matter changes applicable to MRI and CT. Stroke. 2001;32(6):1318-1322. https://doi.org/10.1161/01.STR.32.6.1318
Date of Last Review: September 09, 2026