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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.
Is evidence of amyloid pathology required to use Kisunla® (donanemab-azbt)?
Treatment with Kisunla® (donanemab-azbt) should be initiated in patients with presence of amyloid beta pathology and mild cognitive impairment or mild dementia stage of disease.
See important safety information, including boxed warning, in the attached prescribing information.
Indication and Usage
Donanemab is indicated for the treatment of Alzheimer's disease (AD). Treatment with donanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease.1
Confirm the presence of amyloid beta pathology prior to initiating treatment.1
Donanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody
- directed against insoluble N-truncated pyroglutamate amyloid beta (N3pG) that is localized to deposited amyloid plaque in AD patients,1-3 and
- removes existing cerebral amyloid plaque through microglial-mediated phagocytosis of the deposited amyloid plaque.2,4
Accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of AD.1,3,5
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).
- Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
- DeMattos 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
- 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
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- 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
Date of Last Review: September 04, 2026