You are now leaving the Lilly Medical website
The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to Lilly Medical
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.
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
A phase 3, placebo-controlled 76-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
donanemab 700 mg for the first 3 doses and 1400 mg thereafter (n=860), or
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
In TRAILBLAZER-ALZ 2, infusion-related reactions (IRRs) were reported with an incidence of
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 (Table 1).1,4
The most common adverse reaction that led to discontinuation of donanemab was IRR (Table 1).3
Table 1. Overview of Infusion-Related Reactions: TRAILBLAZER-ALZ 21,3,4
|
Placebo |
Donanemab |
Infusion-related reaction |
4 (0.5) |
74 (8.7) |
Deaths |
0 (0.0) |
0 (0.0) |
Serious adverse events |
0 (0.0) |
1 (0.1) |
Treatment discontinuations |
0 (0.0) |
31 (3.6) |
In the TRAILBLAZER-ALZ 2 study, the majority of IRRs
were mild (57%) or moderate (39%) in severity3
occurred within the first 4 doses of donanemab (70%)3
typically occurred during infusion or within 30 minutes postinfusion, and3
were transient and resolved on the same day (mean duration 0.7 days).4
Of the donanemab-treated participants with immediate events captured on the follow-up forms in the TRAILBLAZER-ALZ 2 study (n=87), 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
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
comparable pharmacodynamic effects on amyloid plaque reduction, and
a reduced incidence of amyloid-related imaging abnormalities compared to the standard dosing regimen.3,5
In the TRAILBLAZER-6 study, all the dosing arms incorporated additional placebo infusions to maintain the study blind. This bi-weekly infusion schedule differed from the once monthly infusion schedule in the donanemab arm in the phase 3 TRAILBLAZER-ALZ 2 study. Participants in the TRAILBLAZER-6 study were also aware of receiving donanemab unlike the other blinded placebo-controlled trials.6
Among the donanemab-treated participants in the TRAILBLAZER-ALZ 6 study, at 52 weeks, IRRs were reported in
16% of participants who received the modified titration regimen (n=212), and
14% of participants who received the standard dosing (n=207).3,4
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
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
KISUNLA® (donanemab-azbt) injection, for intravenous use, Lilly
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1. Sims 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
2. Solomon PR. TRAILBLAZER-ALZ 2: clinical background and study design. Abstract presented at: Alzheimer's Association International Conference (AAIC); July 16-20, 2023; Amsterdam, Netherlands.
3. Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5. Wang 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. 2025;21(8):100266. https://doi.org/10.1016/j.tjpad.2025.100266
6. Wang H, Nery ESM, Ardayfio P, et al. Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction. Alzheimers Dement. 2025;21(4):e70062. https://doi.org/10.1002/alz.70062
Date of Last Review: September 04, 2026