Donanemab

Brand name: Kisunla
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 3, 2024.

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. Kisunla is given as a once-monthly IV infusion.

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 (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

• Serious allergic reactions include swelling of the face, lips, mouth, or eyelids, difficulty breathing, and hives. Tell your healthcare provider if you have any symptoms of a serious allergic reaction during or after your infusion.
• Infusion-related reactions. If you have an infusion-related reaction, your infusion may be slowed down or stopped. Tell your healthcare provider right away if you have symptoms of sweating, irritation of the skin, headache, nausea, chest pain, vomiting, or problems breathing during an infusion chills. If you have had an infusion-related reaction while receiving donanemab, your healthcare provider may give you an antihistamine, acetaminophen, or a steroid before your infusions to decrease your risk of having an infusion reaction.

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

Related/similar drugs

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

Usual Adult donanemab dose: 700 mg every four weeks for three doses, then 1400 mg every four weeks.

Comments:

• Donanemab is given every four weeks as an intravenous infusion over approximately 30 minutes, it must be diluted prior to administration.
• Consider stopping dosing with donanemab based on the reduction of amyloid plaques to minimal levels on amyloid PET imaging.
• If an infusion is missed, resume administration every 4 weeks at the same dose as soon as possible.

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

Interactions

For information on interactions, check the package insert.

Storage

Unopened Vial

• Store refrigerated at 2°C to 8°C (36°F to 46°F).
• Keep the vial in the outer carton to protect it from light.
• Do not freeze or shake.
• If refrigeration is not available, it may be stored at room temperature (20°C to 25°C [68°F to 77°F]) for up to 3 days.

Diluted Solution

• After dilution, immediate use is recommended.
• Diluted solution may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 72 hours or at room temperature (20°C to 25°C [68°F to 77°F]) for up to 12 hours.
• Do not freeze the diluted solution.
• Storage times include the duration of infusion.

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.

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Further information

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

Medical Disclaimer