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.
Can Kisunla™ (donanemab-azbt) be used in patients receiving treatments with other therapeutic antibodies?
Based on the pharmacokinetic characteristics of Kisunla (donanemab), drug interactions with therapeutic antibodies are not expected. Donanemab clinical studies did not explicitly exclude concomitant use of therapeutic antibodies.
See important safety information, including boxed warning, in the attached prescribing information.
Combination Use With Therapeutic Antibodies Has Not Been Studied
The placebo-controlled studies did not explicitly exclude concomitant use of therapeutic monoclonal antibodies.1,2
However, these studies excluded patients from participation if they had current
Drug Interaction Studies Were Not Conducted
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.3
As such, donanemab is not expected to
- inhibit metabolic or induce enzymatic pathways
- be metabolized by the cytochrome P450 families of drug-metabolizing enzymes, or
- produce any active metabolites.4
No formal drug interaction studies were performed with donanemab. No pharmacokinetic drug interactions are expected based on the characteristics of donanemab.4
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Mintun 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
2Sims 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
3Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: August 22, 2023