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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.
Did participants experience anaphylaxis or other hypersensitivity reactions when treated with Kisunla® (donanemab-azbt)?
Hypersensitivity reactions, including anaphylaxis and angioedema, have occurred. Promptly discontinue the donanemab infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Summary of Hypersensitivity and Anaphylactic Reactions
- Hypersensitivity and Anaphylactic Reactions—TRAILBLAZER-ALZ 2
- Incidence
- Serious Adverse Events of Hypersensitivity or Anaphylaxis
- Hypersensitivity and Anaphylactic Reactions—TRAILBLAZER-ALZ 6
- Enclosed Prescribing Information
- References
Summary of Hypersensitivity and Anaphylactic Reactions
Donanemab is contraindicated in patients with a history of serious hypersensitivity to donanemab or to any of the excipients.1
Hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients who were treated with donanemab.1
Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.1
Hypersensitivity and Anaphylactic Reactions—TRAILBLAZER-ALZ 2
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.2
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
- placebo (n=876; administered as saline).2,3
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).1,2
Incidence
Immediate hypersensitivity events (ie, occurring on day of infusion) were reported by 10.4% of donanemab-treated participants and 0.9% of placebo-treated participants in TRAILBLAZER-ALZ 2 (Table 1).4
Nonimmediate events (ie, occurring >24 hours after infusion) were reported by 5.5% in donanemab-treated participants and 4.5% of placebo-treated participants (Table 1).4
Table 1 provides the events reported by more than 1 participant in either treatment group.
Anaphylactic reaction occurred in 3 participants (0.4%) in the donanemab group and were considered to be mild to moderate.2
Table 1. Immediate and Nonimmediate Hypersensitivity Events Reported by >1 Donanemab-Treated or >1 Placebo-Treated Participant: TRAILBLAZER-ALZ 24
Preferred Term |
Placebo |
Donanemab |
|---|---|---|
Immediate |
8 (0.9) |
89 (10.4) |
Infusion-related reaction |
3 (0.3) |
72 (8.4) |
Hypersensitivity |
0 (0.0) |
10 (1.2) |
Anaphylactic reaction |
0 (0.0) |
3 (0.4) |
Urticaria |
0 (0.0) |
2 (0.2) |
Dermatitis contact |
3 (0.3) |
0 (0.0) |
Nonimmediate |
39 (4.5) |
47 (5.5) |
Dermatitis allergic |
1 (0.1) |
2 (0.2) |
Angioedema |
1 (0.1) |
2 (0.2) |
Eyelid edema |
0 (0.0) |
2 (0.2) |
Infusion-related reaction |
2 (0.2) |
2 (0.2) |
Rash erythematous |
1 (0.1) |
2 (0.2) |
Eczema |
4 (0.5) |
3 (0.4) |
Rhinitis allergic |
2 (0.2) |
3 (0.4) |
Dermatitis contact |
3 (0.3) |
4 (0.5) |
Dermatitis |
2 (0.2) |
6 (0.7) |
Rash |
14 (1.6) |
15 (1.8) |
Hypersensitivity |
2 (0.2) |
0 (0.0) |
Swelling face |
2 (0.2) |
0 (0.0) |
Additional information regarding infusion-related reactions is available here.
Serious Adverse Events of Hypersensitivity or Anaphylaxis
Three (0.4%) donanemab-treated participants and 1 (0.1%) placebo-treated participant reported a treatment-emergent hypersensitivity, anaphylactic, or infusion-related serious adverse event (SAE) in TRAILBLAZER-ALZ 2.2,4 No events were fatal. These SAEs included
- infusion-related hypersensitivity reaction (donanemab)
- infusion-related reaction (donanemab)
- urticaria (donanemab), and
- circulatory collapse (placebo).4
Hypersensitivity and Anaphylactic Reactions—TRAILBLAZER-ALZ 6
The TRAILBLAZER-ALZ 6 study investigated the impact of different donanemab dosing options on the frequency of ARIA-E in relation to amyloid reduction. All participants received a dosing regimen that includes donanemab, but at different dose levels and frequency of dosing. The modified titration regimen met the primary objective of >80% probability of achieving ≥20% reduction in relative risk of developing ARIA-E compared with the dosing regimen used in the TRAILBLAZER-ALZ 2 study (referred to as standard dosing in the TRAILBLAZER-ALZ 6 study).5 Therefore, the modified titration regimen is the recommended dosage for donanemab.1
In the modified titration regimen, participants received intravenous donanemab doses every 4 weeks as follows:
- 350 mg for infusion 1
- 700 mg for infusion 2
- 1050 mg for infusion 3, and
- 1400 mg for infusion 4 and beyond.5
Hypersensitivity reactions, including anaphylaxis, occurred in 8% of participants receiving the modified titration in the TRAILBLAZER-ALZ 6 study.1
Enclosed Prescribing Information
KISUNLA® (donanemab-azbt) injection, for intravenous use, Lilly
References
The published references below is available by contacting 1-800-LillyRx (1-800-545-5979).
- Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
- 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
- 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.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- 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;12(8):100266. https://doi.org/10.1016/j.tjpad.2025.100266
Date of Last Review: September 23, 2026