Kisunla (donanemab-azbt) is a brand-name injection for IV infusion that’s prescribed for certain types of Alzheimer’s disease in adults. As with other drugs, Kisunla can cause side effects, such as infusion reactions and headache.
Kisunla has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section.
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.
Kisunla can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects that occurred in people who took Kisunla in clinical trials:
- infusion reactions
- headache
- risk of amyloid-related imaging abnormalities (ARIA)*
* Kisunla has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Side effect specifics” section.
Mild side effects can occur with Kisunla use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Kisunla’s prescribing information.
Mild side effects that have been reported with Kisunla include mild infusion reactions and headache.
These side effects may be temporary, lasting a few hours to days. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the FDA approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Kisunla and want to tell the FDA about it, visit MedWatch.
Kisunla may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Kisunla’s prescribing information.
If you develop serious side effects while taking Kisunla, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported and their symptoms include:
- gastrointestinal perforation, which may include symptoms such as:
- severe stomach pain
- stomach tenderness
- nausea and vomiting
- chills
- fever
- gastrointestinal obstruction, which may include symptoms such as:
- nausea and vomiting
- diarrhea
- constipation
- bloating
- severe pain
- severe infusion reactions*
- risk of ARIA*
* For more information about this side effect, see the “Side effect specifics” section
ALLERGIC REACTIONFor some people, Kisunla injectable solution can cause an allergic reaction.
This side effect wasn’t commonly reported in the drug’s studies.
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 taking 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 injectable solution, your doctor may recommend taking a different medication instead.
Learn more about some of the side effects that Kisunla may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Kisunla.
Risk of amyloid-related imaging abnormalities (ARIA)
Kisunla has a boxed warning for the risk of ARIA. A boxed warning is the most serious warning from the FDA. It alerts people about certain drug effects that may be dangerous.
ARIA was a common side effect reported in studies of Kisunla. These abnormalities are typically seen on imaging of the brain, such as an MRI scan. ARIA occurrence can vary among treatments and can happen at any time during treatment. Usually, ARIA occurs early in treatment.
ARIA usually presents as temporary swelling of the brain that goes away over time. Small bleeding spots may also be found during brain imaging. Large bleeding areas in the brain may occur, but this isn’t common. Rarely, this can lead to other serious complications, such as seizures and death.
More commonly, ARIA doesn’t cause symptoms. However, some people may have symptoms such as:
- nausea
- dizziness
- confusion
- headache
- vision changes
- difficulty walking
Your risk of developing ARIA may be higher if you have certain genes (such as if you carry the homozygous apolipoprotein E ε4 gene).
Taking anticoagulant medications may also increase your risk of having ARIA with brain bleeding. This is because anticoagulant medications can raise the risk of bleeding in your brain. Certain types of ARIA can also cause brain bleeding. So, your risk for this side effect is higher if you take anticoagulant medication with Kisunla.
What you can do
It’s important to talk with your doctor about all your medical conditions and medications, including prescription medications, supplements, and over-the-counter medications. Your doctor will likely have you complete a test to check for the gene mentioned above before they prescribe Kisunla for you. This is to determine your risk for developing ARIA.
Your doctor will also order MRI scans before and during your Kisunla treatment to check for any brain changes that may occur. During the first 24 weeks of treatment, your doctor will monitor you more closely for any brain changes. This is because ARIA typically occurs early in treatment. However, it can happen at any time during treatment.
Symptoms of a stroke may be similar to the ARIA symptoms mentioned above. As a result, it may be hard to determine whether you have ARIA. Talk with your doctor or find medical assistance immediately if you experience the symptoms listed above.
Severe infusion reactions
Severe infusion reactions were not commonly reported in studies of Kisunla. Mild and moderate infusion reactions typically occurred more in people receiving Kisunla.
These infusion reactions may not happen with each dose of Kisunla. Typically, they start early on in treatment. Most reactions that were reported occurred within the first four doses of Kisunla. These reactions typically happen once the infusion starts or within 30 minutes after the infusion.
Symptoms of an infusion reaction may include:
- skin irritation
- nausea and vomiting
- chills
- sweating
- headache
- chest pain
- trouble breathing
What you can do
Your doctor can prescribe certain medications for you to take before your Kisunla infusion to help prevent infusion reactions. They may prescribe the following medications:
- a pain reliever, such as acetaminophen (Tylenol)
- a corticosteroid, such as dexamethasone (Decadron)
- an antihistamine, such as diphenhydramine (Benadryl)
Alert your medical team right away if you develop infusion reactions during or after your Kisunla treatment. In addition to prescribing the above medications, they can slow or stop the infusion during your Kisunla infusion. Your doctor may consider other medications in place of Kisunla if needed in the future.
Below is important information you should consider before taking Kisunla.
Kisunla has a boxed warning. A boxed warning is the most serious warning from the FDA. For details, see the “Side effect specifics” section.
Other precautions
Before taking 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
- pregnancy
- breastfeeding
- alcohol consumption
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.