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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 Kisunla™ (donanemab-azbt) therapy be resumed after treatment pause due to ARIA?
Donanemab should be resumed at the scheduled dose, guided by clinical judgement. In clinical studies, investigators could decide to resume at the same dose or continue the titration schedule based on clinical judgement.
See important safety information, including boxed warning, in the attached prescribing information.
Dosing After Amyloid-Related Imaging Abnormalities Stabilization or Resolution
Consider resuming donanemab dosing once MRI demonstrates radiographic stabilization (for amyloid-related imaging abnormalities-hemosiderin deposition [ARIA-H]) or resolution (for amyloid-related imaging abnormalities-edema [ARIA-E]) and ARIA symptoms, if present, resolve. If an infusion is missed, resume administration every 4 weeks at the scheduled dose as soon as possible. Resumption of dosing should be guided by clinical judgment.1
Dosing in Donanemab Clinical Studies
Dose modifications were not permitted in the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 studies except for in participants who developed ARIA during the titration period. The goal was for study participants to be titrated to the target dose. For participants who developed ARIA during the titration period, the investigator may have decided to
- temporarily suspend dosing, then determine if the participant should remain on the pre-suspension dose either temporarily or throughout the remainder of the treatment period,
- continue the same dose either temporarily or throughout the remainder of the treatment period, or
- continue the dosing schedule.2,3
Dosing and resumption of dosing of donanemab following ARIA stabilization or resolution must ultimately be based on the clinical judgment of the prescribing health care practitioner.
Enclosed Prescribing Information
References
The published reference below is 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
Date of Last Review: October 01, 2025