Lilly is proud to announce that the U.S. Food and Drug Administration(FDA) approved Kisunla™(donanemab-azbt, 350 mg/20 mL once-monthly injection for infusion), which is indicated to treat adults with early symptomatic disease (AD), which includes people with mild cognitive impairment (MCI) or mild dementia stage of AD, with confirmed amyloid pathology.
Learn more about how Kisunla can help adults with early symptomatic Alzheimer’s disease:
Read the press release
Read the Spanish translated press release
Learn more about Kisunla’s pricing
Read about Kisunla
Read about early symptomatic Alzheimer’s disease
Download the product photo and brand logo
Learn more about Lilly’s Alzheimer’s disease clinical trials
For more information, visit www.Kisunla.Lilly.com.
To learn more about Lilly’s work in Alzheimer’s disease, please visit lilly.com/disease-areas/alzheimers.
INDICATION AND SAFETY SUMMARY WITH WARNINGS
Kisunla™(kih-SUHN-lah) is used to treat adults with early symptomatic Alzheimer’s disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease.
Warnings - Kisunla can cause Amyloid-Related Imaging Abnormalities or “ARIA.” This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have:
Headache
Dizziness
Nausea
Difficulty walking
Confusion
Vision changes
Seizures
Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor.
You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk.
Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.
There are registries that collect information on treatments for Alzheimer’s disease. Your healthcare provider can help you become enrolled in these registries.
Warnings - Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion.
Other common side effects
Headache
Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before you receive Kisunla, tell your healthcare provider:
About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin).
About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby.
How to receive Kisunla
Kisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes.
Learn more
For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to kisunla.lilly.com.
This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you.
Please see full Prescribing Information including boxed warning for ARIA and Medication Guide for Kisunla.
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Kisunla™ is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
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