Key takeaways

  • Kisunla (donanemab-azbt) is used to treat Alzheimer’s disease in adults with mild dementia or mild cognitive impairment who have a buildup of beta-amyloid protein in their brains. It works by helping the immune system break down beta-amyloid, which may help slow the worsening of symptoms.
  • The drug is given as an intravenous (IV) infusion once every 4 weeks, starting at 350 milligrams (mg) and increasing to a maintenance dose of 1,400 mg. Your doctor may recommend stopping Kisunla if brain scans show amyloid plaque levels have reached a minimal level.
  • Kisunla carries a boxed warning for amyloid-related imaging abnormalities (ARIA), which can cause bleeding or swelling in the brain. Your risk may be higher if you have a certain genetic factor or take blood thinners. Your doctor will monitor you with MRI scans before your first, 2nd, 3rd, 4th, and 7th infusions.

Kisunla is a brand-name injectable solution, approved by the Food and Drug Administration (FDA) to treat Alzheimer’s disease in certain adults with mild dementia or mild cognitive impairment.

Note: As a person’s condition progresses, they may need help reading or understanding information regarding their circumstances. This article contains details that may help caregivers learn more about Kisunla.

Drug details

Here is key information about Kisunla:

  • Active ingredient: donanemab-azbt
  • Drug class: beta-amyloid-directed antibody (a type of monoclonal antibody)
  • Drug form: liquid solution given as an intravenous (IV) infusion
  • Generic or biosimilar available? no
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: 2024

Kisunla has a boxed warning. This is the most serious warning from the FDA. For details, see the “Boxed warning” section.

Kisunla is a brand-name biologic drug that is not available in a biosimilar form.

Biologic drugs are made using parts of living cells, while traditional drugs are made using chemicals. Instead of generics, which are exact copies of a brand-name drug, biologics have biosimilars. This is because biologics cannot be copied exactly.

Like generics, biosimilars are considered to be as safe and effective as the original brand-name drug, but they tend to cost less.

The following information describes the dosage of Kisunla that is commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug form and strength

Kisunla comes as a liquid solution in a single-use vial. It’s available in one strength of 350 milligrams (mg) per 20 milliliters (mL) of solution (17.5 mg/mL).

How it’s given

A healthcare professional will give you Kisunla as an intravenous (IV) infusion (an injection into a vein that’s given over time). Each Kisunla infusion is typically given over 30 minutes.

You’ll receive Kisunla in a clinic, hospital, or infusion center. You’ll likely stay in the facility where you received the drug for at least 30 minutes after your infusion. This allows your doctor to monitor you closely for serious side effects.

If you have questions about Kisunla infusions, talk with your doctor or visit the drug manufacturer’s website.

Dosage for Alzheimer’s disease

Kisunla dosing follows a titration schedule. This means your doses will increase over time until you reach the maintenance dose.

You’ll receive one infusion every 4 weeks as follows:

  • Infusion 1: 350 mg (one vial)
  • Infusion 2: 700 mg (two vials)
  • Infusion 3: 1,050 mg (three vials)
  • Infusion 4 and beyond: 1,400 mg (four vials)

You’ll continue to receive one infusion every 4 weeks at the 1,400-mg dose.

About receiving Kisunla

The following is information about key dosage issues.

  • When to receive: You’ll receive Kisunla infusions once every 4 weeks.
  • If you miss a dose: If you miss an appointment for your Kisunla infusion, call the clinic, hospital, or infusion center right away to reschedule.
  • Length of use: Kisunla may be used as a long-term treatment. However, your doctor may recommend stopping Kisunla if PET scans indicate your amyloid plaque levels have decreased sufficiently.
  • Length of time to work: Kisunla starts to work after your first dose. Your doctor will order tests, such as PET scans, to help monitor how well the drug is working. They’ll advise you on how your condition is responding to Kisunla.

Kisunla can cause mild to serious side effects. The following lists include some key side effects that may occur, but do not include all possible side effects.

Mild side effects

Mild side effects of Kisunla can include headache or mild infusion reactions, such as chills, nausea, or vomiting.

Most mild side effects go away within a few days to a couple of weeks. However, if they become severe or don’t go away, talk with your doctor or pharmacist.

Experiencing side effects? After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews its side effects. If you develop a side effect while taking this medication and want to report it to the FDA, you can visit MedWatch or call 800-FDA-1088.

Serious side effects

Serious side effects from Kisunla aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

To learn about other Kisunla effects, talk with your doctor or pharmacist, or view the drug’s prescribing information.

Note: Your doctor may pre-treat you with medications such as acetaminophen, antihistamines, or corticosteroids before your infusions to help prevent or manage negative reactions.

ALLERGIC REACTION

For some people, Kisunla can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild skin rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep receiving the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Kisunla, your doctor may recommend a different medication instead.

Alzheimer’s disease is a type of dementia. It affects communication, memory, and thinking. Initially, symptoms may be mild but typically worsen over time. These can include difficulty speaking, changes in personality, and cognitive impairment (the loss of memory and thinking skills).

The cause of Alzheimer’s disease isn’t fully understood, but it may involve the buildup of a brain protein called beta-amyloid. Kisunla can be prescribed for adults with mild dementia or mild cognitive impairment who have a buildup of beta-amyloid in their brains.

How Kisunla works

Kisunla is a beta-amyloid-directed antibody drug. Its mechanism of action (how it works) is by attaching to beta-amyloid proteins in the brain. Kisunla helps the immune system break down beta-amyloid. This leads to lower levels of this protein in the brain, which may help slow the worsening of Alzheimer’s disease symptoms.

If you have questions about how Kisunla works, talk with your doctor. You can also visit the drug manufacturer’s website.

Kisunla and children

Kisunla is not FDA-approved for use in children. It’s not known for sure whether the drug is safe or effective for children.

Kisunla is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer did not list any interactions in the drug’s prescribing information.

However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Kisunla.

Before starting Kisunla treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any herbs, vitamins, or supplements you use. Sharing this information could help you avoid potential interactions.

As with all medications, the cost of Kisunla can vary. The actual price you’ll pay depends on your insurance plan and your location.

A program called Lilly Support Services is available for Kisunla. For more information and to find out whether you’re eligible for support, call 800-545-5979 or visit the program website.

Other drugs that can treat Alzheimer’s disease are available. For example, lecanemab-irmb (Leqembi) and aducanumab-avwa (Aduhelm) are approved for this use.

Some drugs may be a better fit for you than others. If you’re interested in finding an alternative to Kisunla, talk with your doctor.

Kisunla has a boxed warning for the risk of amyloid-related imaging abnormalities (ARIA). A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.

Kisunla may cause changes in your brain called ARIA. This was among the more common side effects in the drug’s clinical trials. In most cases, this condition was temporary and caused mild symptoms. Examples include headache, nausea, and dizziness.

Although rare, ARIA can be more severe or long lasting. It may lead to symptoms such as confusion, changes in vision, or difficulty walking. An MRI scan can detect these changes, which may include bleeding or swelling in your brain.

There are often no symptoms with ARIA, but this condition can be fatal. To help monitor for these changes, your doctor will order an MRI scan of your brain before your first infusion and again before your 2nd, 3rd, 4th, and 7th infusions.

The risk of ARIA is greater for people with a certain genetic (inherited) factor called ApoE ε4. To help assess your risk, your doctor will order a genetic test to check for this factor before you start Kisunla. The risk for ARIA may also be higher in people taking drugs to treat or prevent blood clots, such as blood thinners.

If you have any symptoms of ARIA during Kisunla treatment, contact your doctor right away. However, if your symptoms seem severe or life threatening, call 911 or go to a hospital. You’ll likely receive an MRI brain scan to check for ARIA.

Before receiving Kisunla, discuss your health history with your doctor. This treatment may not be right for you if you have certain medical conditions or other factors affecting your health.

Be sure to tell your doctor if any of the following apply to you:

  • previous allergic reaction to this or a similar drug
  • previous infusion-related reactions

Pregnancy and breastfeeding

It’s not known whether Kisunla treatment is safe during pregnancy or while breastfeeding.

If you’re pregnant, able to become pregnant, breastfeeding, or planning to breastfeed, talk with your doctor before receiving Kisunla infusions.

Disclaimer: While Medical News Today strives for factual, comprehensive, and current information, this article is not a substitute for a licensed healthcare professional’s expertise. Always consult a doctor before taking or discontinuing any medication. Drug information is subject to change and may not cover all uses, directions, precautions, warnings, interactions, reactions, or adverse effects. The lack of a warning does not guarantee a drug’s safety, effectiveness, or appropriateness for all patients or specific uses. Learn more about our approach to content integrity.