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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.
How should infusion reactions to Kisunla® (donanemab-azbt) be managed?
In the event of an infusion-related reaction, reduce the infusion rate or discontinue infusion, and initiate appropriate therapy as clinically indicated. Pre-treatment prior to subsequent dosing may be considered.
See important safety information, including boxed warning, in the attached prescribing information.
Management of Infusion-Related Reactions
In the event of an infusion-related reaction (IRR)
- the infusion rate may be reduced, or the infusion may be discontinued
- initiate appropriate therapy as clinically indicated, and
- consider pretreatment with antihistamines, acetaminophen, or corticosteroids prior to subsequent dosing.1
In the donanemab studies, rescue and prophylaxis medications to manage IRRs were suggested to be utilized at the discretion of investigators.2,3
A review of concomitant medications used during IRRs in an all donanemab analysis set, which included 2727 participants with Alzheimer's disease who received at least 1 dose of donanemab in completed and ongoing phase 2 and phase 3 donanemab studies (includes participants entering the TRAILBLAZER-ALZ 2 long-term extension), not including participants in the TRAILBLAZER-ALZ 6 study, showed that the investigators managed IRRs symptomatically.4
Infusion-Related Reactions in Subsequent Infusions
Interventions used by investigators to reduce the risk of IRRs in the donanemab studies included
- medication used as prophylaxis, and
- slowing of the infusion during or after the IRR.4
Medication Used as Prophylaxis
The use of prophylactic medication to prevent IRRs was not planned in the donanemab studies. However, if an infusion reaction occurred, the participant could be premedicated at subsequent infusions (also called rechallenge infusions).2,3
Dosing rechallenge was contraindicated in participants who experienced a suspected or possible anaphylactic reaction in a prior dose. For IRRs that were not suspicious for anaphylaxis, after review of the data, and at the discretion of the investigator, the participant could be
- rechallenged with an infusion, and
- premedicated for subsequent infusions.4
The prophylactic medications used as premedication on the same day of an infusion in the donanemab studies included
- antihistamines
- acetaminophen, and
- corticosteroids.4
The use of prophylaxis did not notably reduce the chance of experiencing an IRR associated with rechallenge in patients who previously had experienced an IRR. Whether prophylactic medication was used or not on the rechallenge infusion, approximately
- 40% of participants rechallenged experienced an IRR, and
- 60% of participants rechallenged did not experience an IRR (Table 1).4
Table 1. Summary of Prophylactic Medication and IRRs at Rechallenge Infusion4
|
Donanemab |
|---|---|
Participants with IRR |
252 |
Participants with rechallenge infusion |
164/252 (65.1%) |
Prophylactic medication used for rechallenge |
38/164 (23.2%) |
IRR upon rechallenge infusion |
15/38 (39.5%) |
No IRR upon rechallenge infusion |
23/38 (60.5%) |
No prophylactic medication for rechallenge infusion |
126/164 (76.8%) |
IRR upon rechallenge infusion |
53/126 (42.1%) |
No IRR upon rechallenge infusion |
73/126 (57.9%) |
Abbreviation: IRR = infusion-related reaction; N = number of participants included in the all donanemab analysis set who received at least 1 dose of donanemab in completed and ongoing phase 2 and phase 3 donanemab studies.
Slowing of the Infusion During or After the Infusion-Related Reaction
The impact of slowing an infusion at the onset of an IRR event or prophylactically for subsequent infusions was evaluated. A slowed infusion was defined as an infusion lasting 45 minutes or longer, compared with the typical 30 minutes for donanemab.4
Recorded infusion times from trial sites showed that infusions were slowed
- at the first IRR event (26.6%), and
- prophylactically at the rechallenge infusion (43.9%).4
A slower infusion did not reduce the chance of experiencing an IRR associated with rechallenge. Whether slowed infusions were used or not on the rechallenge infusion, approximately
- 40% of participants rechallenged experienced an IRR, and
- 60% of participants rechallenged did not experience an IRR (Table 2).4
Table 2. Summary of Slowed Infusion and IRRs at Rechallenge Infusion4
|
Donanemab |
|---|---|
Participants with first IRR |
252 |
Participants with rechallenge infusion |
164/252 (65.1%) |
Slowed infusion for rechallenge |
72/164 (43.9%) |
IRR upon rechallenge infusion |
30/72 (41.7%) |
No IRR upon rechallenge infusion |
42/72 (58.3%) |
No slowed infusion for rechallenge |
92/164 (56.1%) |
IRR upon rechallenge infusion |
38/92 (41.3%) |
No IRR upon rechallenge infusion |
54/92 (58.7%) |
Abbreviation: IRR = infusion-related reaction; N = number of participants included in the all donanemab analysis set who received at least 1 dose of donanemab in completed and ongoing phase 2 and phase 3 donanemab studies.
Corticosteroid Pretreatment and Infusion-Related Reactions
An addendum to the TRAILBLAZER-ALZ 6 study evaluated the impact of dexamethasone pretreatment on amyloid reduction and safety outcomes, including IRRs. Participants were randomized 2:1 to either dexamethasone (n=251) or placebo (n=125), administered before each of the first 6 donanemab infusions. The addendum is ongoing, with a planned total duration of 76 weeks.5
Among participants who received pretreatment with dexamethasone, IRR frequency was 10.0% (n=25) compared with 16.0% (n=20) in the placebo group (p=.094).5
Enclosed Prescribing Information
KISUNLA® (donanemab-azbt) injection, for intravenous use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
- Mintun 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
- 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
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- Monkul Nery ES, Doty EG, Fox N, et al. Corticosteroid pretreatment with modified titration of donanemab: TRAILBLAZER-ALZ 6 addendum amyloid reduction and safety. Abstract presented at: Alzheimer's Association International Conference (AAIC); July 12-15, 2026; London, United Kingdom.
Date of Last Review: July 24, 2026