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  1. Medical Information Right
  2. Neuroscience Right
  3. Kisunla (donanemab-azbt) injection, for intravenous infusion Right
  4. How is Kisunla™ (donanemab-azbt) prepared for administration?
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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 is Kisunla™ (donanemab-azbt) prepared for administration?

Withdraw the required volume of donanemab and dilute it with 0.9% Sodium Chloride Injection to achieve a final concentration between 4 mg/mL and 10 mg/mL.

US_cFAQ_DON602A_DILUTION_INSTRUCTIONS_ESAD_ON
US_cFAQ_DON602A_DILUTION_INSTRUCTIONS_ESAD_ONen-US

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

Dilution Instructions

Donanemab is supplied in a single-dose vial containing 350 mg/20 mL (17.5 mg/mL).1

Prior to administration, donanemab must be diluted with 0.9% Sodium Chloride Injection, USP.1

Each vial is for one-time use only. Discard any unused portion left in the vial.1

Use aseptic technique when preparing the donanemab diluted solution for intravenous infusion.1

Allow donanemab to equilibrate to room temperature before preparation.1

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Donanemab solution is clear to opalescent, colorless to slightly yellow to slightly brown. Do not use if particulate matter or discolorations are present.1

Volume Calculation to Prepare the Infusion Solution

Withdraw the required volume of donanemab and mix with 0.9% Sodium Chloride Injection for a final concentration of 4 mg/mL to 10 mg/mL (Preparation and Reconstitution of Donanemab). Use only 0.9% Sodium Chloride Injection for dilution.1 

Preparation and Reconstitution of Donanemab1

Donanemab Dose

Donanemab Volume (Number of Vials)

Volume of 0.9% Sodium Chloride Injection Diluent

Final Volume of Diluted Solution to be Infused

Final Concentration of Diluted Solution (mg/mL)a

350 mg

20 mL (1)

15 mL to 67.5 mL

35 mL to 87.5 mL

350 mg/87.5 mL (4 mg/mL) to 350 mg/35 mL (10 mg/mL)

700 mg

40 mL (2)

30 mL to 135 mL

70 mL to 175 mL

700 mg/175 mL (4 mg/mL) to 700 mg/70 mL (10 mg/mL)

1050 mg

60 mL (3)

45 mL to 202.5 mL

105 mL to 262.5 mL

1050 mg/262.5 mL (4 mg/mL) to 1050 mg/105 mL (10 mg/mL)

1400 mg

80 mL (4)

60 mL to 270 mL

140 mL to 350 mL

1400 mg/350 mL (4 mg/mL) to 1400 mg/140 mL (10 mg/mL)

aFinal concentration of 4 mg/mL to 10 mg/mL.

Using the guidance provided in Preparation and Reconstitution of Donanemab, an example of preparing a 700 mg dose of donanemab would be to

  • withdraw donanemab from 2 vials (40 mL total), and
  • add this 40 mL of donanemab to 100 mL of 0.9% sodium chloride injection diluent.

This results in a final volume of diluted solution to be infused of 140 mL, with a final concentration of 5 mg/mL (ie, 700 mg/140 mL).

After dilution, gently invert the donanemab diluted solution to mix completely. Do not shake.1

The diluted solution of donanemab should be infused over a minimum of 30 minutes. The use of a filter is not required for the infusion of donanemab.1

The range of final concentrations provided allows flexibility in reconstitution to accommodate availability of resources at various institutions.2

Enclosed Prescribing Information

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

References

1Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.

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

Date of Last Review: June 13, 2025

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