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Donanemab

Brand name: Kisunla (kih-SUHN-lah)  
Dosage form: injection for intravenous use (350 mg/20 mL)
Drug class: Miscellaneous central nervous system agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on Jul 13, 2025.

What is donanemab?

Donanemab (Kisunla) is used to Alzheimer’s disease to help slow down the decline in memory, thinking, and daily functioning. This means that Alzheimer’s disease does not progress as quickly, and people can continue living their lives doing their daily activities and hobbies for a longer time. 

Alzheimer's disease symptoms are thought to be related to clumps of amyloid protein (amyloid plaques) that can occur in the brain. Donanemab is an amyloid plaque-targeting therapy that works by helping the body remove amyloid plaques in the brain, which slows the progression of Alzheimer’s disease.

Donanemab is administered as a once-monthly IV infusion that takes approximately 30 minutes. The dose is increased slowly over the first 4 infusions to reduce the risk of side effects.

Donanemab (Kisunla) FDA approval was received on July 2, 2024, as a treatment for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with mild dementia stage of AD, with confirmed amyloid pathology. Kisunla (donanemab) is an Eli Lilly and Company product.

How well does it work?

Kisunla (donanemab) significantly slowed Alzheimer's disease progression by more than 20% at 76 weeks in the TRAILBLAZER-ALZ 2  clinical trial. This was measured using the Integrated Alzheimer’s Disease Rating Scale (iADRS) and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score in patients with low/medium tau and in the combined low/medium and high tau populations.

Treatment with Kisunla benefited all groups of trial participants, but patients in earlier stages of the disease showed the most significant improvements.

Donanemab side effects 

Common donanemab side effects

Common Kisunla side effects include headache and swelling in areas of the brain with or without small spots of bleeding in or on the brain's surface. These occurred in at least 10% of patients and at a higher incidence compared to placebo. 

Serious donanemab side effects 

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

 Also, see the Warning section

Warnings

Donanemab can cause serious side effects, including:

Amyloid-Related Imaging Abnormalities or ARIA.

ARIA is a common side effect that does not usually cause any symptoms, but sometimes serious symptoms can occur. ARIA can be fatal. It is most commonly seen in an MRI as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur. 

Most people who develop ARIA do not have symptoms; however, some people may have symptoms such as headache, dizziness, nausea, difficulty walking, confusion, vision changes, and seizures.

If you have any of the symptoms of ARIA listed above, you should call your healthcare provider or go to the nearest hospital emergency room right away. 

You are more at risk of ARIA if you have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers). Your healthcare provider may test to see if you have this risk factor.

If you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving donanemab, you may be at a higher risk of developing bleeding in the brain.

Magnetic resonance imaging (MRI) scans are done before and during your treatment to check you for ARIA.

You should carry information that you are receiving donanemab, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms.

There are registries that collect information on treatments for Alzheimer’s disease. Your healthcare provider can help you become enrolled in these registries. 

Consider the risk of ARIA and the benefit of Alzheimer's disease when deciding to treat with donanemab.

Who should not take donanemab?

You should not receive this medicine if you have had serious allergic reactions to donanemab-azbt or any of the ingredients in this infusion. See the end of this document for a complete list of ingredients.

Before taking this medicine

Pregnancy

Tell your healthcare provider if you plan to become pregnant, become pregnant, or are pregnant, as it is not known if this medicine will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed, as it is not known if the active ingredient in Kisunla passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving this medicine.

How will I receive this medicine?

Donanemab is given as an infusion into a vein (IV infusion) in your arm, which will last about 30 minutes.
Donanemab is given every 4 weeks. If you miss an infusion, you should receive your next dose as soon as possible.

Donanemab dosing information

Donanemab is given every 4 weeks with an initial increasing dosing schedule.

Usual adult donanemab dose is every 4 weeks:

Comments:

Dose modifications may be required for patients with ARIA-E and ARIA-H 

Donanemab (Kisunla) is available as: 350 mg/20 mL (17.5 mg/mL) in a single-dose vial.

Interactions  

Other drugs may interact with donanemab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Does Donanemab interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Donanemab Package Insert 

HCPs and patients often use the Donanemab Package Insert (PI) - Kisunla brand for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Donanemab Prescribing Information (PI) or FDA label.

Storage

Unopened Vial 

Diluted Solution

Kisunla Ingredients

Active ingredient: donanemab-azbt

Inactive ingredients: anhydrous citric acid, polysorbate 80, sodium citrate, sucrose, and Water for Injection, USP.

Manufacturer

Eli Lilly and Company, Indianapolis, IN 46285, USA

Donanemab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for donanemab.

Kisunla (donanemab-azbt) - Eli Lilly and Company
Formulation type Strength
Single-Dose Vial 350 mg/20 mL (17.5 mg/mL)

View Kisunla information in detail.

Popular FAQ

How quickly does Kisunla start working?

In the TRAILBLAZER-ALZ 2 study with 1,736 people, those with the least advanced disease experienced the strongest outcomes, with a 35% slowing of cognitive and functional decline at 76 weeks on the Integrated Alzheimer’s Disease Rating Scale (iADRS), a tool which measures memory, thinking, and daily functioning. Continue reading

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.