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  1. Medical Information Right
  2. Neuroscience Right
  3. Kisunla (donanemab-azbt) injection, for intravenous infusion Right
  4. Who is the intended patient for Kisunla™ (donanemab-azbt) treatment?
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Kisunla ™ (donanemab-azbt) injection, for intravenous infusion

350 mg/20 mL (17.5 mg/mL)

Full Prescribing Information

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.

Who is the intended patient for Kisunla™ (donanemab-azbt) treatment?

Treatment with Kisunla (donanemab) should be initiated in patients with mild cognitive impairment or mild dementia due to AD with presence of amyloid beta pathology.

US_cFAQ_DON400A_INTENDED_PATIENT_ESAD_ON
US_cFAQ_DON400A_INTENDED_PATIENT_ESAD_ONen-US

See important safety information, including boxed warning, in the attached prescribing information.

Patient Identification in the Donanemab Studies

Donanemab is indicated for the treatment of Alzheimer's disease (AD). Treatment with donanemab should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.1

Confirm the presence of amyloid beta pathology prior to initiating treatment.1

Information on patient selection in the TRAILBLAZER-ALZ 2 study is summarized.

Evidence of AD Neuropathology

In the phase 3, placebo-controlled TRAILBLAZER-ALZ 2 study, AD neuropathology was established by evidence of

  • pathologic tau deposition on flortaucipir F 18 positron emission tomography (PET), and
  • amyloid neuritic plaque deposition on amyloid PET.1,2

Cognitive Impairment Criteria

In the TRAILBLAZER-ALZ 2 study, MCI or mild dementia due to AD was defined by

  • gradual and progressive change in memory functions for ≥6 months and
  • a Mini-Mental State Examination (MMSE) score of 20 to 28 inclusive.1,2

Enclosed Prescribing Information

KISUNLA™ (donanemab-azbt) injecton, for intravenous use, Lilly

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; 2024.

2Sims 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: June 08, 2023

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