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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 renal function?
No dosing adjustments are needed for Kisunla (donanemab) in patients with renal impairment.
See important safety information, including boxed warning, in the attached prescribing information.
Dosage Adjustments Are Not Required in Patients With Renal Impairment
Donanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody and is expected to be degraded by proteolytic enzymes in the same manner as endogenous IgG.1
Donanemab is not expected to undergo renal elimination.1
No studies were conducted to evaluate the pharmacokinetics (PK) of donanemab in participants with renal impairment.1
Donanemab PK was not influenced by Cockcroft-Gault creatinine clearance (range 32 to 133 mL/min) in a population PK analysis using data collected from 177 subjects with Alzheimer's disease (n=27 normal renal function; n=98 mild renal impairment; n=52 moderate renal impairment).2
Renal function classifications were defined as
- normal (creatinine clearance ≥90 mL/min)
- mild impairment (60 mL/min≤creatinine clearance<90 mL/min)
- moderate impairment (30 mL/min≤creatinine clearance<60 mL/min), or
- severe impairment (15 mL/min≤creatinine clearance<30 mL/min).2
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
2Gueorguieva 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
Date of Last Review: December 08, 2023