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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.
What information is available on infusion reactions in patients receiving Kisunla™ (donanemab-azbt)?
Infusion-related reactions occurred in 9% to 16% of donanemab-treated participants in clinical trials. The majority occurred within the first 4 infusions, and typically during infusion or within 30 minutes postinfusion.
See important safety information, including boxed warning, in the attached prescribing information.
Infusion-Related Reactions in Clinical Trials
TRAILBLAZER-ALZ 2
A phase 3, placebo-controlled 72-week study, TRAILBLAZER-ALZ 2, evaluated the safety and efficacy of donanemab in adults aged 60 to 85 years with early symptomatic Alzheimer's disease.1
Participants were randomized at the beginning of double-blind treatment in a 1:1 ratio to receive intravenous infusions every 4 weeks of either
Baseline demographics were similar between donanemab and placebo treatment groups. The 853 donanemab-treated participants were mostly female (57%) and white (91%), with a mean age of 73 years at study entry (range 59 to 86 years).1,3
Incidence
Infusion-related reactions (IRRs) were the most commonly reported hypersensitivity event in TRAILBLAZER-ALZ 2, with an incidence of
- 9% in donanemab-treated participants, and
- 0.5% in placebo-treated participants (Overview of Infusion-Related Reactions: TRAILBLAZER-ALZ 2).1,3
Serious IRRs or hypersensitivity events occurred in 0.4% of donanemab participants (n=3) and 0.1% of placebo participants (n=1). One of the serious adverse events in the donanemab participants was an IRR (Overview of Infusion-Related Reactions: TRAILBLAZER-ALZ 2).1,4
The most common adverse reaction that led to discontinuation of donanemab was IRR (Overview of Infusion-Related Reactions: TRAILBLAZER-ALZ 2).3
Severity and Timing
In the TRAILBLAZER-ALZ 2 study, the majority of IRRs
Of donanemab-treated participants in the TRAILBLAZER-ALZ 2 study, 16% reported events occurring >30 minutes up to 24 hours postinfusion. Of these
- 9% had events beyond 30 minutes and up to 6 hours from end of treatment administration, and
- 7% had events beyond 6 hours and up to 24 hours from end of treatment administration.4
Infusion reactions and hypersensitivity reactions were reported more than 24 hours after a donanemab infusion in 5.5% of donanemab-treated participants in the TRAILABLAZER-ALZ 2 study.4
TRAILBLAZER-ALZ 6
The effectiveness of donanemab for the treatment of Alzheimer’s disease was established by TRAILBLAZER-ALZ 2,1 which assessed a dosing regimen of 700 mg every 4 weeks for the first 3 doses, and then 1,400 mg every 4 weeks (referred to as standard dosing in TRAILBLAZER-ALZ 6). The TRAILBLAZER-ALZ 6 study5 was conducted to assess different titration regimens, including the modified dosing regimen (ie, currently approved dosing of every 4 weeks with 350 mg the first infusion, 700 mg the second infusion, 1,050 mg the third infusion, and then 1,400 mg thereafter). The currently approved dose demonstrated
Incidence
Severity and Timing
In the TRAILBLAZER-ALZ 6 study, the majority of IRRs
- were mild (47%) or moderate (50%) in severity
- occurred within the first 4 doses of donanemab (88%), and
- typically occurred during infusion or within 30 minutes postinfusion.3
Signs and Symptoms of Infusion-Related Reactions
Signs and symptoms of IRRs include
- chills
- erythema
- nausea/vomiting
- flushing
- difficulty breathing/dyspnea
- sweating
- elevated blood pressure
- headache
- chest pain, and
- low blood pressure.3
The most commonly reported symptoms of IRRs in donanemab-treated participants included erythema, chills, nausea/vomiting, sweating, difficulty breathing/dyspnea, elevated blood pressure, and other symptoms.4
In the event of an IRR,
- the infusion rate may be reduced, or the infusion may be discontinued
- initiate appropriate therapy as clinically indicated
- consider pretreatment with antihistamines, acetaminophen, or corticosteroids prior to subsequent dosing.3
Information about infusion reaction management in the donanemab studies is available here.
Enclosed Prescribing Information
References
The published reference below is 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
2Solomon PR. TRAILBLAZER-ALZ 2: clinical background and study design. Abstract presented at: Alzheimer's Association International Conference (AAIC); July 16-20, 2023; Amsterdam, Netherlands.
3Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Wang H, Nery ESM, Ardayfio P, et al. The effect of modified donanemab titration on amyloid-related imaging abnormalities with edema/effusions and amyloid reduction: 18-month results from TRAILBLAZER-ALZ 6. J Prev Alzheimers Dis. Published online July 5, 2025. https://doi.org/10.1016/j.tjpad.2025.100266
Date of Last Review: July 10, 2025