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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 hepatic function?
No dosing adjustments are needed for donanemab in patients with hepatic impairment.
See important safety information, including boxed warning, in the attached prescribing information.
No Dose Adjustment Is Necessary in Patients With Hepatic 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 metabolism by hepatic enzymes.1
No studies were conducted to evaluate the pharmacokinetics (PK) of donanemab in participants with hepatic impairment.1
Hepatic impairment did not affect the PK of donanemab in a population PK analysis using data collected from 177 subjects with Alzheimer's disease (n=167 normal hepatic status; n=10 mild hepatic impairment).2
Normal hepatic status was defined as
- total bilirubin (TBL)≤upper limit of normal (ULN), and
- aspartate aminotransferase (AST)≤ULN.2
Mild hepatic impairment was defined as
- TBL≤ULN and AST>ULN, or
- TBL>(1.0-1.5)X ULN with any AST.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