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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.
Can Kisunla® (donanemab-azbt) be used in patients who are not candidates for MRI?
The donanemab studies excluded participants with contraindications for MRI. Monitoring for ARIA by MRI should be completed prior to and during treatment with donanemab.
See important safety information, including boxed warning, in the attached prescribing information.
What MRI‑Related Exclusion Criteria Were Applied in Donanemab Clinical Studies?
The placebo-controlled studies excluded participants from study participation if they had any contraindications for magnetic resonance imaging (MRI), including
- claustrophobia, or
- the presence of contraindicated metal implants or a cardiac pacemaker.1,2
Amyloid-Related Imaging Abnormalities
Amyloid-related imaging abnormalities (ARIA) can be detected by brain MRI and have been observed in clinical trials of monoclonal antibodies directed against aggregated forms of beta amyloid.3,4
The most common adverse reactions reported by donanemab-treated participants in the placebo-controlled studies were
- amyloid-related imaging abnormalities-edema (ARIA-E)
- amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H) microhemorrhage, and
- ARIA-H superficial siderosis.3
Monitoring for ARIA
The donanemab prescribing information recommends
- enhanced clinical vigilance for ARIA during the first 24 weeks of treatment with donanemab, and
- baseline brain MRI and periodic monitoring with MRI.3
Obtain a recent brain MRI at baseline prior to treatment initiation with donanemab;3 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.3
Enclosed Prescribing Information
KISUNLA® (donanemab-azbt) injection, for intravenous use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Mintun 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
- Sims 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
- Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
- Sperling 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
Date of Last Review: April 24, 2026