Kisunla is a once-monthly IV (intravenous) infusion given by a healthcare provider

Here are a few things to expect:

Kisunla is given via IV infusion through a needle placed in a vein in the arm once every 4 weeks
Each infusion takes around 30 minutes
After the infusion, you will need to stay at the medical center for 30 minutes or more for observation
Throughout your treatment journey, your doctor will monitor and evaluate how you are doing on treatment
Your doctor will determine how long you will be on treatment

In a clinical study, 17% of people were able to stop taking Kisunla at 6 months, 47% at 12 months, and 69% at 18 months if their amyloid plaques were reduced to a predefined level

PET scans were used to determine amyloid levels in the study. People who were able to stop treatment were switched to placebo. The long-term clinical benefit of Kisunla after stopping treatment has not been studied.

How should you prepare for your first infusion appointment?

Here are some helpful tips so you can prepare for your appointment:

Arrive early (around 15 to 30 minutes before) in case you need to fill out any paperwork

Make sure you’re hydrated. Drink plenty of water before, during, and after your appointment

Wear comfortable clothes. If you come in long sleeves, make sure they can be rolled over your elbows. Bring a sweater, in case it’s cold in the infusion center

Bring something to keep yourself busy. It can be a book, a tablet, or headphones to listen to your favorite music

SELECT SAFETY INFORMATION

Kisunla can cause serious allergic and infusion-related reactions. 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.

Learn about some potential side effects with Kisunla

See possible side effects

SAFETY SUMMARY WITH WARNINGS

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.

DN CON BS APP

Kisunla^™ is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

INDICATION

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.