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What to expect throughout your Kisunla journey

From evaluation and testing to diagnosis, learn some things you can expect throughout your journey

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What to expect throughout your Kisunla journey

From evaluation and testing to diagnosis, learn some things you can expect throughout your journey

This is an example of the steps someone may experience to get started on Kisunla. Individual experiences vary.

Step 1

Talk with your primary care physician (PCP) about an evaluation for your memory and thinking issues

Step 2

You may be referred to a specialist for further testing

Step 3

See if Kisunla treatment is right for you

If your doctor diagnoses you with early symptomatic Alzheimer's disease (AD), ask if Kisunla may be right for you.

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Step 1

Talk with your primary care physician (PCP) about an evaluation for your memory and thinking issues

Make an appointment to talk to your PCP about your memory and thinking issues. It may be helpful to explain specific situations when you have experienced memory and thinking issues, whether they are becoming more frequent, and what your loved ones are noticing about your symptoms. Discuss your medical and family history with your doctor as well.

Discuss with your doctor:

How do I know if my memory and thinking issues might be more than normal aging?

My memory and thinking issues are becoming more frequent. Are there evaluations and tests we can do to assess if something is wrong? (ie, discuss medical and family history, cognitive assessments, blood work, Alzheimer's disease (AD) blood tests that may assess biomarkers such as P-tau217, etc)

Your doctor may then perform a cognitive, functional and/or behavioral assessment
Your doctor may run routine blood work that may help identify what is contributing to your memory and thinking issues
Based on your blood work, your doctor will follow up with you to explain the results

Step 2

You may be referred to a specialist for further testing

Next, your doctor may refer you to a specialist. Different types of specialists include geriatric psychiatrists, neuropsychiatrists, neurologists, and geriatricians. You may want to bring a loved one to the appointment. Wait times for seeing a specialist vary by office and geography but can sometimes take months.

Discuss with your doctor:

Should I be referred to a specialist to explore what’s causing the issues I’m having?

What is involved in the referral process? How long will it take?

Your specialist may review your PCP evaluation and perform tests to further determine if your memory and thinking issues could be due to an abnormal buildup of amyloid plaque in the brain.

Discuss with your doctor:

What are my testing options to check for an abnormal buildup of amyloid plaques in the brain?

Current options include an Alzheimer's disease (AD) blood test (eg, those that measure P-tau217), a cerebrospinal fluid (CSF) test, or positron emission tomography (PET) scan.

Alzheimer's disease (AD) blood tests

Biomarkers, or biological markers, are signs about your health that your doctor evaluates in testing. AD blood tests may assess biomarkers such as P-tau217, which could help determine the likelihood of the presence of abnormal amyloid plaque buildup in your brain. The results inform your doctor's diagnosis and will help with their recommendation of potential treatment options.

Positron emission tomography (PET) scan

A PET scan produces an image of the brain and can show if amyloid plaque buildup is present. This can help your doctor determine a diagnosis, which will help inform potential treatment options.

Cerebrospinal fluid (CSF) test

A CSF test is an assessment that requires a lumbar puncture to help your doctor identify amyloid plaque buildup. The results inform your doctor’s diagnosis and will help with their recommendation of potential treatment options.

Must meet testing criteria. These tests are not intended to be used as a standalone diagnostic.

P-tau=phosphorylated tau.

Step 3

See if Kisunla treatment is right for you

If your doctor diagnoses you with early symptomatic Alzheimer's disease (AD), ask if Kisunla may be right for you

Discuss with your doctor:

How do anti-amyloid treatments work if I’m diagnosed with early symptomatic AD?

What are possible side effects, and how do you monitor for them during treatment?

Before you begin Kisunla infusions, you will undergo a baseline magnetic resonance image (MRI). Routine MRIs are one of the multiple ways your doctor will monitor you for potential side effects throughout treatment

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.

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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.