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.
Is evidence of amyloid pathology required to use Kisunla™ (donanemab-azbt)?
Treatment with Kisunla (donanemab) 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
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.
2DeMattos 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
3Sims 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
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Mintun 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: December 07, 2023