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  1. Medical Information Right
  2. Neuroscience Right
  3. Kisunla (donanemab-azbt) injection, for intravenous infusion Right
  4. How should Kisunla™ (donanemab-azbt) be administered?
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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.

How should Kisunla™ (donanemab-azbt) be administered?

Kisunla (donanemab) is administered as an intravenous infusion over approximately 30 minutes.

US_cFAQ_DON601A_ADMINISTRATION_INSTRUCTIONS_ESAD_ON
US_cFAQ_DON601A_ADMINISTRATION_INSTRUCTIONS_ESAD_ONen-US

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

Administration Instructions

Prior to infusion, 

  • allow the donanemab diluted solution to warm to room temperature, and
  • visually inspect the donanemab diluted solution for particles or discoloration.1

Do not use if it is discolored, or opaque or foreign particles are seen.1

Administer the entire diluted solution intravenously over approximately 30 minutes.1

Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity-type reaction and initiate appropriate treatment.1 The Infusion-Related Reactions and Hypersensitivity Reactions  sections provide further information.

Flush the line only with 0.9% Sodium Chloride Injection at the end of infusion per access-specific line maintenance protocol.1

Observe the patient postinfusion for a minimum of 30 minutes to evaluate for infusion reactions and hypersensitivity reactions.1

Infusion-Related Reactions

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

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

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

In some patients, infusion reactions and hypersensitivity reactions were reported more than 24 hours after a donanemab infusion.2

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

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) injecton, for intravenous use, Lilly

Reference

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

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: August 25, 2023

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