If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
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.
Exclusion Criteria
ARIA—The Most Common Adverse Reaction With Donanemab Treatment
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
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Mintun 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
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
3Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
4Sperling 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: August 18, 2023