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Hope is here with Kisunla

An anti-amyloid treatment that can slow the progression of early symptomatic Alzheimer’s disease (AD)

Actor Portrayals.

Actor Portrayals.

Hope is here with Kisunla

An anti-amyloid treatment that can slow the progression of early symptomatic Alzheimer’s disease (AD)

It’s possible to significantly reduce amyloid plaques associated with early symptomatic AD when taking Kisunla

Kisunla is for adults with early symptomatic AD, which includes mild cognitive impairment (MCI) or mild dementia stage of disease.

In a clinical study at 18 months, people treated with Kisunla showed a significant reduction in amyloid plaques compared with those who were given placebo.

Kisunla can slow the progression of early symptomatic AD, which presents with memory and thinking issues

While Kisunla cannot reverse or stop existing memory and thinking issues that are due to early symptomatic AD, it can help slow the progression of the disease.

After 18 months in a clinical study, people treated with Kisunla showed a significant slowing of decline of 22%, on average, compared with placebo.

The study population had varying levels of tau, a protein in the brain associated with AD. A higher amount of this protein is thought to be a factor in determining how far along a person is in the disease progression.

SELECT SAFETY INFORMATION

Kisunla can cause Amyloid-Related Imaging Abnormalities, or “ARIA.” ARIA is a common but serious side effect that does not usually cause any symptoms, but can be serious. 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.

For those with early symptomatic AD

Kisunla can help lower the risk of progressing to the next stage of AD

In a clinical study, people treated with Kisunla had a 37% lower risk of progressing to the next stage of disease through 18 months compared with those taking placebo.

Understanding the symptomatic stages of AD

Learn some of the signs and symptoms of each stage—and at which stage Kisunla can help

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Early Stage: Mild Cognitive Impairment (MCI) or Mild Dementia

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This is when Kisunla may be right for you.

You may notice small changes–like forgetting names or losing your train of thought–but you're still able to take care of yourself and live independently. Loved ones can help support you and motivate you to take action.

Because Kisunla is a treatment for the early symptomatic stage of AD, don’t wait to take the first step. Talk to your doctor about how Kisunla can help.

Middle Stage: Moderate AD

Daily routines will become harder to manage alone. Support from loved ones becomes more important in helping you stay safe and engaged as you may be confused more often and tend to wander or get lost.

Late Stage: Severe AD

With memory and thinking issues becoming more severe, you will depend on others for everyday tasks like eating, dressing, or getting around. Loved ones will often take on a larger caregiving role during this time, offering daily support and care.

Kisunla is not indicated to treat middle and late stages of AD.

Treatment options are available, including therapies that target symptoms such as memory, thinking, behavior, and mood.

SELECT SAFETY INFORMATION

(ARIA, continued) Kisunla can cause Amyloid-Related Imaging Abnormalities, or "ARIA." Although most people do not have symptoms, some people have headache, dizziness, nausea, difficulty walking, confusion, vision changes, and seizures. Call your healthcare provider or go to the emergency room right away if you have any of these symptoms. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms.

It’s possible to complete a treatment course with Kisunla in as early as 6 months

Your doctor may consider completing your Kisunla treatment course if your amyloid plaque levels are reduced to minimal levels*

In a clinical study, 17% of people were able to complete treatment course with 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 complete their treatment course were switched to placebo.

Amyloid PET values may increase after completing treatment course with Kisunla. There are no data beyond the 18-month duration of the study to guide whether additional dosing with Kisunla may be needed for longer-term clinical benefit.

The long-term clinical benefit of Kisunla after completing treatment course has not been studied.

*Amyloid levels measured by PET scan.

Those who had no notable amyloid plaque reaccumulation 1 year after completing treatment were part of a small subset of the overall population and were less progressed in their disease.

A separate analysis showed that low amounts of amyloid plaque may reaccumulate per year after completing treatment course. The duration of efficacy beyond 76 weeks has not been established, as there are no data to inform whether additional dosing with Kisunla may be needed for longer-term clinical benefit.

SELECT SAFETY INFORMATION

(ARIA, continued) Kisunla can cause Amyloid-Related Imaging Abnormalities, or "ARIA." 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 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.

Getting started with Kisunla

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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 registered 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.