Patient Medication Information: uses, side effects, how to take - Kisunla
What is KISUNLA used for:
KISUNLA is a prescription medicine used to treat adults with early stages of Alzheimer’s disease who do not carry a gene called apolipoprotein E ε4, also known as ApoE4, or in adults
Serious Warnings and Precautions
KISUNLA can cause serious side effects, including:
Amyloid-Related Imaging Abnormalities or “ARIA”. ARIA is a very common side effect that does not usually cause any symptoms; however, ARIA can be serious and result in hospitalization or death. ARIA-H can occur spontaneously in patients with Alzheimer’s disease but is more common in people taking drugs like KISUNLA. ARIA is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain, and infrequently, larger areas of bleeding in the brain can occur. Although most people who experience ARIA do not have symptoms, some may experience:
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Your healthcare professional will do magnetic resonance imaging (MRI) scans before and during your treatment with KISUNLA to check you for ARIA. Some people carry a certain gene called apolipoprotein E4 (ApoE ε4). These people may be at higher risk for developing ARIA. Your healthcare professional will test if you are a ApoE ε4 carrier to determine if KISUNLA is suitable for you.
Call your healthcare professional or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.
It is important that healthcare professionals know you are taking KISUNLA. Some of the symptoms listed above are similar to those of other conditions, like stroke. Treatment for those conditions while you are taking KISUNLA could be dangerous. Carry your patient alert card and/or wear your patient bracelet at all times, to show that you are taking KISUNLA. Educational materials for patients and care providers can be accessed at: kisunlapatient.ca who carry one copy of this gene. Your healthcare professional will perform testing to make sure that KISUNLA is right for you.
Alzheimer's disease is a common type progressive, chronic disease that destroys brain cells. Alzheimer's disease affects all aspects of a person’s life and causes a decline in the ability to think, remember, and participate in activities of daily living. Alzheimer's disease is not a normal part of aging.
A Canadian Patient Registration Program has been established to monitor the safety of KISUNLA. You may be enrolled in this registration program at the time of treatment initiation. More information may be found at: kisunlapatient.ca
Patients treated with KISUNLA must be given the Patient Alert Card. Additional educational materials have been developed for patients and caregivers. These can be accessed at: kisunlapatient.ca
How KISUNLA works:
KISUNLA contains the active substance ‘donanemab’, an antibody that recognizes and bind specifically to certain proteins in the body.
KISUNLA works by removing clumps (called plaques) of a sticky protein called beta-amyloid from the brain. The amyloid plaques are suggested to cause Alzheimer’s disease.
The ingredients in KISUNLA are:
Medicinal ingredients: donanemab
Non-medicinal ingredients: anhydrous citric acid, polysorbate 80, sodium citrate, sucrose, and water for injection.
KISUNLA comes in the following dosage forms:
Intravenous Infusion:
- Single-use vial: 17.5 mg/mL (350 mg/20 mL)
Do not use KISUNLA if:
- You are allergic to donanemab or any of the other ingredients of this medicine. See The ingredients in KISUNLA are
- You carry two copies of a gene called apolipoprotein E ε4
- You previously had bleeding in the brain or if the Magnetic Resonance Imaging (MRI) shows small spots of bleeding or fluid in the brain.
- You have an uncontrolled bleeding problem.
- You are receiving medicines (anticoagulants) to prevent blood clots.
- You have changes and damage to your brain’s white matter, the pale tissue containing nerve fibres (structures like threads).
- You cannot undergo an MRI because you live with a fear of enclosed spaces (claustrophobia), you have metal implants or you have been implanted with a metal cardiac rhythm management device (pacemaker) or do not have access to an MRI during your treatment.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take KISUNLA. Talk about any health conditions or problems you may have, including if you:
are pregnant or plan to become pregnant. It is not known if KISUNLA will harm your unborn baby. Tell your healthcare professional if you become pregnant during your treatment with KISUNLA.
- are breastfeeding or plan to breastfeed. It is not known if donanemab (the active ingredient in KISUNLA) passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby while receiving KISUNLA.
Other warnings you should know about:
Tell your healthcare professional if you have allergic symptoms or an allergic reaction during or after KISUNLA infusion.
Disease progression:
Your healthcare professional may stop your treatment with KISUNLA if your Alzheimer’s disease gets worse.
Driving and using machines:
Some people may experience symptoms such as dizziness or confusion. This could affect the ability to drive and use machines, therefore, caution is recommended.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with KISUNLA:
- Medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin).
- You should not take KISUNLA if you are taking blood thinning medicines (anticoagulants).
How to take KISUNLA:
- KISUNLA will be given to you under the supervision of a healthcare professional experienced in the diagnosis and treatment of Alzheimer's disease with timely access to MRI.
- Your healthcare professional will confirm that you have amyloid in your brain through a Positron Emission Tomography (PET) scan, a lumbar puncture (spinal tap) or other equivalent tests.
- KISUNLA is given by a healthcare professional through a needle placed in your vein (intravenous [IV] infusion) in arm.
- KISUNLA is given once every 4 weeks. Each infusion will last about 30 minutes. The longest duration of treatment with KISUNLA is one and a half years (18 months).
Serious allergic reactions:
Serious allergic reactions can occur with KISUNLA. Some reactions can be serious and can lead to hospitalization.
Symptoms of allergic reactions that have commonly occurred during a KISUNLA infusion include:
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- Your healthcare professional may recommend taking a pain-relieving medication, antihistamine or corticosteroid before your infusion to help prevent an infusion-related reaction.
Usual dose:
The recommended dosing schedule is as follows:
| Intravenous Infusion (every 4 weeks and at least 21 days apart) | KISUNLA Dosage |
|---|---|
| Infusion 1 | 350 mg |
| Infusion 2 | 700 mg |
| Infusion 3 | 1,050 mg |
| Infusion 4 and beyond up to a maximum of 18 months (20 infusions) | 1,400 mg |
Your healthcare professional will arrange Magnetic Resonance Imaging (MRI) scans to check for Amyloid-Related Imaging Abnormalities (ARIA) before your first infusion and then before the second (Week 4), fourth (Week 12) and seventh (Week 24) dose of KISUNLA. An additional MRI before your fourteenth dose (Week 52) will be arranged if you have risk factors such as 1 copy of the ApoE ε4 gene and/or previous ARIA events earlier in treatment.
Your healthcare professional may perform additional MRIs if you have symptoms that may be due to ARIA (see Serious Warnings and Precautions for a list of possible symptoms). However, ARIAs often occur without any symptoms. It is important that you go to the MRI appointments your healthcare professional schedules for you to make sure you have not developed harmful brain swelling or bleeding.
Overdose:
If you think you, or a person you are caring for, have taken too much KISUNLA, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms.
Missed dose:
If you miss an infusion, contact your healthcare professional as soon as possible for further instructions.
Possible side effects from using KISUNLA:
These are not all the possible side effects you may have when taking KISUNLA. If you experience any side effects not listed here, tell your healthcare professional.
In addition to the serious side effects in the table below, common side effects (may affect more than 1 in 100 people) in KISUNLA clinical trials included fall, headache, dizziness, arthralgia (joint pain), and fall.
Serious side effects and what to do about them
| Frequency/side effect/Symptom | Tell your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| ARIA (Swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain) * | √ | √ | |
| COMMON | |||
| Infusion-related reaction (a type of allergic reaction occurring during or soon after infusion). | √ | √ | |
| UNCOMMON | |||
| Anaphylaxis (sudden, severe allergic reaction with breathing difficulty, swelling, light-headedness, fast heartbeat, sweating, and loss of consciousness) | √ | √ | |
* See the Serious Warnings and Precautions box at the start of this Patient Medication Information leaflet for symptoms you might have with ARIAs.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional. If you develop an infusion- related reaction, treatment with antihistamines, or corticosteroids prior to future infusions may be considered.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
KISUNLA should only be prepared and administered by a trained health care professional.
If you want more information about KISUNLA:
- Talk to your healthcare professional.
- A Patient Alert Card is available for patients and caregivers. This contains important safety information and should be carried at all times.
- A Patient Alert Bracelet and KISUNLA appointment tracker are also available from your Healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (www.lilly.ca), or by calling 1-888-545-5972.
Date of Authorization: 2026-04-30
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