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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.
How does Kisunla™ (donanemab-azbt) work?
Kisunla (donanemab) is a humanized immunoglobulin G1 monoclonal antibody directed against N3pG amyloid beta that is localized to deposited amyloid plaque in patients with Alzheimer's disease.
See important safety information, including boxed warning, in the attached prescribing information.
Mechanism of Action of Donanemab
The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease (AD).1-4
Donanemab is a humanized immunoglobulin gamma 1 monoclonal antibody that
- is directed against the insoluble N-truncated terminal, third amino acid, pyroglutamate formation (N3pG) amyloid beta epitope that is localized to deposited amyloid plaque in patients with Alzheimer's disease,5-7 and
- removes existing cerebral amyloid plaque through microglial-mediated phagocytosis.5,7,8
Donanemab reduced amyloid beta plaques in a dose- and time-dependent manner compared with placebo, as measured by amyloid positron emission tomography.1
See here for a video illustrating how donanemab works in early symptomatic AD.
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.
2Raskin J, Cummings J, Hardy J, et al. Neurobiology of Alzheimer's disease: integrated molecular, physiological, anatomical, biomarker, and cognitive dimensions. Curr Alzheimer Res. 2015;12(8):712-22. http://dx.doi.org/10.2174/1567205012666150701103107
3Querfurth HW, LaFerla FM. Alzheimer’s disease. N Engl J Med. 2010;362(4):329-344. https://doi.org/10.1056/NEJMra0909142
4Hyman BT, Phelps CH, Beach TG, et al. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012;8(1):1-13. http://dx.doi.org/10.1016/j.jalz.2011.10.007
5DeMattos RB, Lu J, Tang Y, et al. A plaque-specific antibody clears existing β-amyloid plaques in Alzheimer's disease mice. Neuron. 2012;76(5):908-920. http://dx.doi.org/10.1016/j.neuron.2012.10.029
6Mintun 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
7Sims 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
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: January 02, 2025