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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 unable to receive certain contrast dyes?
The placebo-controlled studies did not require contrast dyes for monitoring ARIA by MRI.
See important safety information, including boxed warning, in the attached prescribing information.
Monitoring for ARIA
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
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; 2024.
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
Date of Last Review: August 18, 2023