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  1. Medical Information Right
  2. Neuroscience Right
  3. Kisunla (donanemab-azbt) injection, for intravenous infusion Right
  4. Is Kisunla™ (donanemab-azbt) safe for patients allergic to other amyloid-targeting therapies?
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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.

Is Kisunla™ (donanemab-azbt) safe for patients allergic to other amyloid-targeting therapies?

Donanemab has not been studied in patients with allergies to other amyloid-targeting therapies. The placebo-controlled studies excluded patients with allergies to monoclonal antibodies.

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

Potential For Cross-Allergy With Other Amyloid-Targeting Therapies is Unknown

Donanemab has not been studied in patients with allergies to other amyloid-targeting therapies.

Infusion-related reactions (IRRs) and hypersensitivity reactions have occurred in participants who were treated with donanemab.1

It is not known if a previous allergy to another amyloid-targeting therapy constitutes a risk factor for treatment with donanemab. The TRAILBLAZER-ALZ and TRAILBLAZER-ALZ 2 studies excluded patients from participation if they had

  • allergies to monoclonal antibodies, donenemab or related compounds, or
  • a history of clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions.2,3

Infusion-related Reactions

The majority of IRRs in the phase 3 TRAILBLAZER-ALZ 2 study

  • occurred within the first 4 doses of donanemab (70%), and
  • typically occur during infusion or within 30 minutes postinfusion.1

Infusion reactions and hypersensitivity reactions were reported more than 24 hours after a donanemab infusion in 5.5% of donanemab-treated participants.4

Signs and symptoms of IRRs include

  • chills
  • erythema
  • nausea/vomiting
  • difficulty breathing/dyspnea
  • sweating
  • elevated blood pressure
  • headache
  • chest pain, and
  • low blood pressure.1

In the event of an IRR, the infusion 

  • rate may be reduced, or
  • may be discontinued.1

Initiate appropriate therapy as clinically indicated.1 

Pretreatment with antihistamines, acetaminophen, or corticosteroids prior to subsequent dosing may be considered.1 

Hypersensitivity Reactions

Donanemab is contraindicated in patients with known serious hypersensitivity to donanemab or to any of the excipients.1 

Hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients who were treated with donanemab.1

Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy.1

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).

1Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.

2Mintun 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

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

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: January 03, 2025

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