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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 is the recommended dose of Kisunla™ (donanemab-azbt)?
After initial dose escalation, the recommended dose of donanemab is 1400 mg, administered every 4 weeks as an intravenous infusion over approximately 30 minutes.
See important safety information, including boxed warning, in the attached prescribing information.
Recommended Dosage and Administration
Donanemab is administered every 4 weeks as an intravenous infusion over approximately 30 minutes as described in (Donanemab Dosage and Dosing Schedule).1
Intravenous Infusiona |
Dosage |
Interval |
Infusion 1 |
350 mg |
Q4W |
Infusion 2 |
700 mg |
Q4W |
Infusion 3 |
1050 mg |
Q4W |
Infusion 4 and beyond |
1400 mg |
Q4Wb |
Abbreviations: IV = intravenous; Q4W = every 4 weeks.
aIf an infusion is missed, resume administration every 4 weeks at the scheduled dose.
bDoses are administered via IV infusion every 4 weeks and at least 21 days apart.
Consider stopping dosing with donanemab based on reduction of amyloid plaques to minimal levels on amyloid positron emission tomography (PET) imaging. In the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 studies, dosing was stopped based on a reduction of amyloid levels below predefined thresholds on PET imaging.1
The TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 studies, participants were eligible to be switched from donanemab to placebo if the amyloid plaque levels were
Amyloid plaque was considered to be reduced to minimal levels when the amyloid plaque level was <24.1 centiloids (CL) on an amyloid PET scan, which is consistent with a negative visual read of an amyloid PET scan.5
Clinical Studies
The effectiveness of donanemab for the treatment of Alzheimer’s disease was established by TRAILBLAZER-ALZ 2,3 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 study4 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
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Sims 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
4Wang 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
5Navitsky M, Joshi AD, Kennedy I, et al. Standardization of amyloid quantitation with florbetapir standardized uptake value ratios to the Centiloid scale. Alzheimers Dement. 2018;14(12):1565-1571. https://doi.org/10.1016/j.jalz.2018.06.1353
Date of Last Review: June 13, 2025