Kisunla is a brand-name injectable solution prescribed for Alzheimer’s disease in certain situations. Kisunla contains the active ingredient donanemab-azbt and is a type of monoclonal antibody.

Kisunla is FDA approved to treat Alzheimer’s disease in certain adults who have 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:

  • Drug class: beta-amyloid-directed antibody
  • Drug form: 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 Food and Drug Administration (FDA). For details, see the “Kisunla precautions” 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.

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 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).

Dosage for Alzheimer’s disease

Kisunla is prescribed to treat Alzheimer’s disease in certain adults. For details, see the “Kisunla uses” section.

The usual starting dose of Kisunla is 700 mg (two vials) per infusion. You’ll receive one infusion every 4 weeks for three doses.

After that, the typical ongoing dosage of Kisunla is 1,400 mg (four vials) per infusion. You’ll continue to receive one infusion every 4 weeks.

How it’s given

A healthcare professional will give you Kisunla as an intravenous (IV) infusion. An IV infusion is an injection into a vein that’s given over a period of 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 other questions about receiving Kisunla, talk with your doctor. You can also visit the drug manufacturer’s website.

About receiving Kisunla

Here, you’ll find 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. Your doctor will monitor your condition and recommend how long you’ll receive Kisunla.
  • Length of time to work: Kisunla starts to work after your first dose. Your doctor will give you 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 or serious side effects. The following lists contain some of the key side effects that may occur while receiving Kisunla. These lists do not include all possible side effects.

For more information about the possible side effects of Kisunla, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Kisunla, you can do so through MedWatch.

Mild side effects

Here are a few mild side effects of Kisunla. To learn about other mild side effects, talk with your doctor or pharmacist, or view Kisunla’s prescribing information.

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

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

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:

* Kisunla has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Kisunla precautions” section.

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 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.

The Food and Drug Administration (FDA) approves prescription drugs such as Kisunla to treat certain conditions.

Kisunla for Alzheimer’s disease

Kisunla is approved to treat Alzheimer’s disease in certain adults.

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.

To learn more about Kisunla for Alzheimer’s disease, talk with your doctor.

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 vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

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

Financial and insurance assistance: If you need financial support to pay for Kisunla, or if you need help understanding your insurance coverage, help is available.

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.

Generic or biosimilar version: Kisunla is not available in a biosimilar form. As with generics, biosimilars may cost less and are considered to be as safe and effective as the original brand-name drug. For details about biosimilars, see the “Kisunla generic or biosimilar” section.

To learn more about saving money on prescriptions, check out this article.

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. They can tell you about other medications that treat Alzheimer’s disease.

If you can become pregnant, consider the following information about pregnancy and breastfeeding.

Kisunla and pregnancy

It’s not known whether Kisunla should be given during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before receiving this medication.

Kisunla and breastfeeding

It’s not known whether Kisunla should be given while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before receiving this medication.

Kisunla is used to treat Alzheimer’s disease in certain adults. The cause of Alzheimer’s disease isn’t fully understood, but it may involve the buildup of a brain protein called beta-amyloid.

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

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

This drug comes with several precautions.

FDA warning: Amyloid-related imaging abnormalities

This drug has a boxed warning. This is a serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Kisunla may cause changes in your brain called amyloid-related imaging abnormalities (ARIA). An MRI scan can detect these changes, which may include bleeding or swelling in your brain. To help monitor for these changes, your doctor will take MRI scans of your brain before and during Kisunla treatment.

ARIA was among the more common side effects in Kisunla’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. This may lead to symptoms such as confusion, changes in vision, or difficulty walking.

The risk of ARIA may be greater for people with a certain genetic (inherited) factor. The risk can also increase for people taking medications that 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 will likely receive a brain MRI scan to check for ARIA.

Other precautions

Before receiving Kisunla, discuss your health history with your doctor. Kisunla may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

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

Note: For more information about the potential negative effects of Kisunla, see the “Kisunla side effects” section.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.