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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.
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.
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
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 |
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) |
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. To preserve blinding in the clinical trial, a final volume of 140 mL was used for placebo and both the 700 mg and 1400 mg donanemab doses, which resulted in a final concentration of 5 mg/mL for the 700 mg dose, and 10 mg/mL for the 1400 mg dose.2
Modified Titration: Dosing and Preparation
The TRAILBLAZER-ALZ 6 study investigated the impact of different donanemab dosing options on the frequency of amyloid-related imaging abnormalities-edema in relation to amyloid reduction.3 In the modified titration regimen, participants received intravenous donanemab doses every 4 weeks of
- 350 mg for infusion 1
- 700 mg for infusion 2
- 1050 mg for infusion 3, and
- 1400 mg for infusion 4 and beyond.3
Consistent with the recommendations in the prescribing information, the modified titration doses should be
- diluted to a final concentration between 4 mg/mL and 10 mg/mL, and
- infused over a minimum of 30 minutes.
Enclosed Prescribing Information
References
1Kisunla [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Wang H, Nery ESM, Ardayfio P, et al. The effect of different donanemab dosing regimens on ARIA-E and amyloid lowering in adults with early symptomatic Alzheimer's disease: primary outcome results from TRAILBLAZER-ALZ 6. Presentation at: 17th Clinical Trials on Alzheimer’s Disease (CTAD); October 29-November 1, 2024; Madrid, Spain.
Date of Last Review: January 03, 2025