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  1. Medical Information Right
  2. Neuroscience Right
  3. Kisunla (donanemab-azbt) injection, for intravenous infusion Right
  4. Can Kisunla™ (donanemab-azbt) be used in patients who are not candidates for MRI?​
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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.

Can Kisunla™ (donanemab-azbt) be used in patients who are not candidates for MRI?​

The donanemab studies excluded participants with contraindications for MRI. Monitoring for ARIA by MRI should be completed prior to and during treatment with donanemab.

US_cFAQ_DON409A_USE_PTS_MRI_CONTRAINDICATED_ESAD_ON
US_cFAQ_DON409A_USE_PTS_MRI_CONTRAINDICATED_ESAD_ONen-US

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

Exclusion Criteria

The placebo-controlled studies excluded participants from study participation if they had any contraindications for magnetic resonance imaging (MRI), including

  • claustrophobia, or
  • the presence of contraindicated metal implants or a cardiac pacemaker.1,2

ARIA—The Most Common Adverse Reaction With Donanemab Treatment

Amyloid-related imaging abnormalities (ARIA) can be detected by brain MRI and have been observed in clinical trials of monoclonal antibodies directed against aggregated forms of beta amyloid.3,4

The most common adverse reactions reported by donanemab-treated participants in the placebo-controlled studies were

  • amyloid-related imaging abnormalities-edema (ARIA-E)
  • amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H) microhemorrhage, and
  • ARIA-H superficial siderosis.3

Monitoring for ARIA

The donanemab prescribing information recommends

  • enhanced clinical vigilance for ARIA during the first 24 weeks of treatment with donanemab, and
  • baseline brain MRI and periodic monitoring with MRI.3

Obtain a recent brain MRI at baseline prior to treatment initiation with donanemab;3 the prescribing clinician should use clinical judgment to determine what constitutes a "recent" MRI.  In the TRAILBLAZER-ALZ 2 study, the baseline MRI was performed within 49 days of treatment initiation.2

Obtain additional MRIs

  • prior to the second, third, fourth, and seventh infusions, and
  • if symptoms suggestive of ARIA occur.3

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).

1Mintun 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

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

3Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.

4Sperling RA, Jack Jr CR, Black SE, et al. Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: recommendations from the Alzheimer’s Association Research Roundtable Workgroup. Alzheimers Dement. 2011;7(4):367-385. https://doi.org/10.1016/j.jalz.2011.05.2351

Date of Last Review: August 18, 2023

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