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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 patients on other amyloid-targeting therapies switch to Kisunla™ (donanemab-azbt)?
The effects of switching from another amyloid-targeting therapy to donanemab have not been studied. Clinicians should assess whether a patient is a candidate for switching from another amyloid-targeting therapy to donanemab.
See important safety information, including boxed warning, in the attached prescribing information.
Use Clinical Judgment When Considering Switching From Another Amyloid-Targeting Therapy to Donanemab
The safety and efficacy of switching from an amyloid-targeting therapy (ATT) to donanemab for the treatment of Alzheimer's disease (AD) have not been systematically studied.
The donanemab clinical studies allowed participants with prior passive anti-amyloid immunotherapy treatment to enroll if they were more than 5 half-lives post treatment prior to randomization.1,2
Data were not collected on prior ATT treatment in the donanemab studies. The impact of prior ATT treatment on the incidence or severity of safety events such as amyloid-related imaging abnormalities (ARIA) or infusion-related reactions (IRR) are unknown.
Clinicians should give careful consideration to patients with prior exposure to ATT to determine whether an individual patient is a candidate for switching from one ATT to another in the treatment of AD. Decisions regarding the optimal time between treatment with one ATT and switching to another are best determined based on clinician and patient agreement that consider the patient’s
- cognitive and neuropathological status
- needs, and
- safety.
Consider Cognitive Status When Initiating Donanemab
The cognitive status of the patient is an important consideration when deciding whether to switch a patient from another ATT to donanemab.
Donanemab is indicated for the treatment of AD. Treatment with donanemab should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.3
The safety or effectiveness of donanemab for treatment at earlier or later stages of the disease have not been established.5
Confirm the presence of amyloid beta pathology prior to initiating treatment.3
Safety Considerations When Initiating Donanemab
The safety and risk profile of switching from an amyloid-targeting therapy to donanemab have not been systematically studied and are unknown.
Monoclonal antibodies directed against beta amyloid, including donanemab, can cause ARIA, and IRRs.3,4
Amyloid-related imaging abnormalities include
Amyloid-related imaging abnormalities are usually asymptomatic, although serious and life-threatening events rarely can occur. In addition to ARIA, intracerebral hemorrhages greater than 1 cm in diameter (ie, macrohemorrhages) have occurred in patients treated with donanemab.3
The prescribing information provides more information regarding
- IRRs, and
- ARIA safety and monitoring.3
Information regarding appropriate patient selection for donanemab is available here.
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Sims 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
2Mintun 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
3Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
4Leqembi [package insert]. Nutley, NJ: Eisai; 2023.
5Data on file, Eli Lilly and Company and/or one of its subsidiaries.
6Cogswell PM, Barakos JA, Barkhof F, et al. Amyloid-related imaging abnormalities with emerging Alzheimer disease therapeutics: detection and reporting recommendations for clinical practice. AJNR Am J Neuroradiol. 2022;43(9):E19-E35. https://doi.org/10.3174/ajnr.A7586
7Sperling 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: May 29, 2025