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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.
Is more frequent monitoring for ARIA needed in APOE ε4 carriers treated with Kisunla™ (donanemab-azbt)?
The recommendations on monitoring for ARIA do not differ between APOE ε4 carriers and noncarriers treated with donanemab. Testing for APOE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
See important safety information, including boxed warning, in the attached prescribing information.
Amyloid-Related Imaging Abnormalities Monitoring in APOE ε4 Carriers
The presence of apolipoprotein subtype E allele 4 (APOE ε4) has been recognized as a risk factor for developing amyloid-related imaging abnormalities-edema (ARIA-E) and amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H).1
The recommendations on monitoring for amyloid-related imaging abnormalities (ARIA) do not differ between APOE ε4 carriers and noncarriers.2
Testing for APOE Genotype
Testing for APOE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.2
Prior to testing, prescribers should discuss with patients the
- risk of ARIA across genotypes, and
- implications of genetic testing results.2
Prescribers should inform patients that if genotype testing is not performed, they can still be treated with donanemab; however, it cannot be determined if they are APOE ε4 homozygotes and at higher risk for ARIA.2
A Food and Drug Administration (FDA) authorized test for detection of APOE ε4 alleles to identify patients at higher risk of ARIA if treated with donanemab is not currently available. Currently available tests used to identify APOE ε4 alleles may vary in accuracy and design.2
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 magnetic resonance imaging (MRI) and periodic monitoring with MRI.2
Obtain a recent brain MRI at baseline prior to treatment initiation with donanemab;2 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.3
Obtain additional MRIs
- prior to the second, third, fourth, and seventh infusions, and
- if symptoms suggestive of ARIA occur.2
If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.2
Consider a follow-up MRI to assess for resolution (ARIA-E) or stabilization (ARIA-H) 2 to 4 months after initial identification.2
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Sperling 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
2Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
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: September 11, 2023