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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.
Should the dose of Kisunla™ (donanemab-azbt) be adjusted for age?
No dosing adjustments are needed for Kisunla (donanemab) based on age.
See important safety information, including boxed warning, in the attached prescribing information.
No Dose Adjustment Is Necessary Based on Age
The pharmacokinetics (PK) of donanemab was not affected by age based on a population PK analysis using data collected from 177 participants with Alzheimer's disease aged 54 to 88 years.1,2
In the TRAILBLAZER-ALZ 2 study,3 the age of participants ranged from 59 to 86 years, with a mean age of 73 years. Specifically,
- 90% were 65 years and older, and
- 41% were 75 years and older.2
No overall differences in safety or effectiveness of donanemab have been observed between patients 65 years of age and older and younger adult patients.2
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Gueorguieva I, Willis BA, Chua L, et al. Donanemab population pharmacokinetics, amyloid plaque reduction, and safety in participants with Alzheimer’s disease. Clin Pharmacol Ther. 2023;118(36):1258-1267. https://doi.org/10.1002/cpt.2875
2Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
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
Date of Last Review: July 18, 2023