Kisunla (Donanemab)
Anti-Amyloid Monoclonal Antibody for Early Alzheimer’s Disease
Quick Facts About Kisunla
Key Takeaways About Kisunla
- First treatment targeting amyloid clearance: Kisunla is a disease-modifying therapy that actively removes amyloid plaques from the brain, slowing cognitive decline by approximately 35% compared to placebo in clinical trials
- Time-limited treatment: Unlike many Alzheimer’s medications, Kisunla has a defined treatment course of up to 18 months, with many patients achieving amyloid-negative status and discontinuing treatment
- Regular MRI monitoring required: Due to the risk of amyloid-related imaging abnormalities (ARIA), including brain swelling and microbleeds, regular MRI scans are mandatory before and during treatment
- ApoE ε4 genotyping is essential: Genetic testing for the ApoE ε4 allele is required before starting treatment, as homozygous carriers (two copies) face higher ARIA risk and are not included in the approved indication
- Cannot be combined with anticoagulants: Kisunla must not be used in patients taking blood-thinning medications (anticoagulants) due to the increased risk of brain haemorrhage
What Is Kisunla and What Is It Used For?
Kisunla (donanemab) is a monoclonal antibody that targets and removes amyloid beta plaques from the brain. It is used to slow the progression of Alzheimer’s disease in adults with early symptomatic disease who have confirmed amyloid pathology and carry zero or one copy of the ApoE ε4 gene.
The active substance in Kisunla is donanemab, a humanised immunoglobulin G1 (IgG1) monoclonal antibody. It belongs to the class of medicines used for dementia diseases. Donanemab is a protein engineered to mimic natural antibodies produced by the immune system. It specifically recognises and binds to a modified form of amyloid beta called N-terminal pyroglutamate amyloid beta (N3pG Aβ), which is a major component of the amyloid plaques that accumulate in the brains of people with Alzheimer’s disease.
By binding to amyloid beta plaques, donanemab recruits the brain’s immune cells – primarily microglia – to engulf and clear these deposits. This process, known as antibody-mediated phagocytosis, progressively reduces the overall amyloid burden in the brain. In clinical trials, approximately 80% of participants treated with donanemab achieved amyloid-negative status (defined as less than 24.1 centiloids on amyloid PET scanning) by 12 months of treatment.
Amyloid beta plaques are one of the two key pathological hallmarks of Alzheimer’s disease, the other being tau tangles. While amyloid plaques begin accumulating years or even decades before symptoms appear, their continued presence is associated with ongoing neurodegeneration, cognitive decline, and functional impairment. By removing these plaques, donanemab aims to slow the downstream neurodegenerative cascade.
Kisunla is specifically indicated for adults who have an abnormal accumulation of amyloid beta proteins in the brain and who have either mild cognitive impairment (difficulty thinking, remembering, and making decisions) or mild dementia (loss of intellectual function) due to Alzheimer’s disease. The medicine is approved for use in adults who carry only zero or one copy of the apolipoprotein E4 (ApoE ε4) gene. Your doctor will conduct genetic testing and brain imaging to determine whether Kisunla is appropriate for you.
Donanemab was evaluated in the landmark TRAILBLAZER-ALZ 2 clinical trial, a large Phase 3 randomised, double-blind, placebo-controlled study involving 1,736 participants with early symptomatic Alzheimer’s disease. The trial demonstrated that donanemab slowed clinical decline as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS) by approximately 35% over 76 weeks in the combined low/medium tau population. Approximately 47% of participants treated with donanemab showed no disease progression at one year, compared to 29% on placebo.
What Should You Know Before Taking Kisunla?
Before starting Kisunla, you must undergo an MRI brain scan, ApoE ε4 genotyping, and a comprehensive medical evaluation. Kisunla is contraindicated in patients with a history of brain haemorrhage, those on anticoagulants, patients with uncontrolled high blood pressure, and those unable to undergo MRI monitoring.
Contraindications
You should not receive Kisunla if any of the following apply to you:
- Allergy to donanemab or any other ingredient in Kisunla (listed in the composition section below)
- History of brain haemorrhage or if an MRI scan shows pre-existing small bleeds (microhaemorrhages) or fluid accumulation in the brain
- Uncontrolled bleeding disorders – conditions that prevent your blood from clotting properly
- Taking anticoagulant medications – medicines that prevent blood clots, such as warfarin, heparin, or direct oral anticoagulants (DOACs like apixaban, rivaroxaban, dabigatran, edoxaban)
- Significant white matter lesions – damage to the white matter of the brain detected on MRI, which contains nerve fibres
- Uncontrolled high blood pressure – blood pressure that is not adequately managed with treatment
- Unable to undergo MRI – for example, due to claustrophobia, incompatible metal implants, or metallic cardiac pacemakers
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before receiving Kisunla. Several important safety considerations must be understood before and during treatment.
Infusion-Related Reactions
Tell the healthcare professional administering your infusion immediately if you experience an allergic reaction during or shortly after your Kisunla infusion. Symptoms of infusion-related reactions may include flushing, chills, nausea, vomiting, sweating, headache, chest tightness, shortness of breath, and changes in blood pressure. These reactions typically occur during the first few infusions and become less frequent over time. Your healthcare team will monitor you for at least 30 minutes after each infusion.
Amyloid-Related Imaging Abnormalities (ARIA)
Kisunla can cause a side effect called amyloid-related imaging abnormalities (ARIA). This is the most important safety consideration associated with this treatment. There are two types of ARIA:
- ARIA-E (oedema): Accumulation of fluid in one or more areas of the brain, causing swelling
- ARIA-H (haemorrhage): Small bleeds (microhaemorrhages) in the brain or on the brain surface (superficial siderosis)
ARIA is a side effect that most commonly occurs early in treatment, typically during the first 24 weeks. Most people who develop ARIA do not experience symptoms – the changes are detected on routine MRI monitoring. However, there have been cases of ARIA that led to serious symptoms during treatment with Kisunla, some of which have been fatal. These serious cases typically occurred within the first 12 weeks of treatment.
Contact your doctor immediately if you experience symptoms that may suggest ARIA, including: headache, confusion, nausea, vomiting, poor balance, dizziness, tremors, vision changes, speech difficulties, or seizures. Do not wait for your next scheduled appointment.
ARIA is detected through MRI brain scans. Your doctor will arrange MRI scans at the following timepoints:
- Within 6 months before starting treatment (baseline)
- Before the 2nd, 3rd, 4th, and 7th infusions
- Before the 12th infusion (at approximately one year) if you carry one copy of the ApoE ε4 gene, or if you have had ARIA during treatment
- Additional MRI scans at any time if you experience symptoms suggestive of ARIA
Your doctor may temporarily or permanently discontinue Kisunla treatment depending on MRI findings and your symptoms.
Genetic Risk Factors for ARIA
Some individuals carry a particular variant of a gene called apolipoprotein E4 (ApoE ε4). People who carry this gene variant may be at higher risk of developing ARIA. Specifically, individuals who are homozygous for ApoE ε4 (carrying two copies of the gene) face a substantially higher risk of ARIA, including serious and fatal cases. Before treatment with Kisunla is initiated, your doctor will perform a genetic test to determine your ApoE ε4 status. Kisunla is approved only for patients with zero or one copy of this gene.
Tau Testing
Your doctor may also test you for tau protein levels if deemed clinically necessary. Tau is another protein in the brain involved in Alzheimer’s disease. At certain levels of tau, Kisunla may work more effectively. The TRAILBLAZER-ALZ 2 trial showed that patients with low to intermediate tau levels experienced the greatest clinical benefit from donanemab treatment.
Children and Adolescents
Kisunla should not be used in children and adolescents under 18 years of age. The medicine has not been studied in this age group, and Alzheimer’s disease does not typically affect young people.
Down Syndrome
Kisunla should not be used in patients with Down syndrome who have Alzheimer’s disease. The medicine has not been studied in these patients, and the benefit-risk profile has not been established for this population.
Other Medications
Tell your doctor or pharmacist about all medications you are currently taking, have recently taken, or might take. It is particularly important to inform your doctor or pharmacist before receiving Kisunla if you take anticoagulant medications (blood thinners that prevent blood clots). Kisunla must not be used in combination with anticoagulants due to the significantly increased risk of brain haemorrhage.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you might be pregnant, or are planning to have a baby, consult your doctor or pharmacist before receiving this medicine. The effects of Kisunla on pregnant women are unknown. The use of Kisunla during pregnancy should be avoided unless the potential benefit justifies the potential risk to the foetus. Given the typical age of onset of Alzheimer’s disease, pregnancy is unlikely in the target patient population, but it is important to discuss family planning with your doctor.
Driving and Operating Machinery
Some side effects of Kisunla, particularly symptoms of ARIA such as vision changes, altered consciousness, and seizures, can affect your ability to drive and operate machinery. If you experience any neurological symptoms during treatment, do not drive or operate heavy machinery until the symptoms have fully resolved and your doctor has confirmed it is safe to do so.
Important Information About Ingredients
Sodium content: This medicine contains 46 mg of sodium (the main component of table salt) per 1400 mg dose. This is equivalent to approximately 2% of the recommended maximum daily dietary intake of sodium for an adult. Before receiving Kisunla, it is diluted with a solution that may also contain sodium. Talk to your doctor if you are on a low-sodium diet.
Polysorbate 80: This medicine contains 16 mg of polysorbate 80 per 1400 mg dose (approximately 0.23 mg/kg). Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergies to polysorbate 80.
Your doctor will give you a patient safety card containing important safety information about Kisunla. It is essential to carry this card with you at all times and show it to family members or carers. The card should also be shown to any other healthcare professional treating you, including in emergency situations.
How Does Kisunla Interact with Other Drugs?
The most critical drug interaction for Kisunla is with anticoagulants (blood thinners), which are strictly contraindicated. Caution is also advised with antiplatelet agents, thrombolytics, and other medications that increase bleeding risk. Unlike many oral medications, donanemab has limited pharmacokinetic drug interactions as it is a monoclonal antibody cleared by proteolytic degradation rather than hepatic metabolism.
Donanemab is a monoclonal antibody, and as such, it is not metabolised by hepatic cytochrome P450 enzymes. This means that the pharmacokinetic interactions commonly seen with small-molecule drugs (where one drug affects the metabolism of another through enzyme inhibition or induction) are generally not expected with donanemab. However, pharmacodynamic interactions – where the combined effects of two drugs lead to clinical consequences – are highly relevant, particularly concerning bleeding risk.
Critical Interactions
| Drug/Class | Category | Effect | Recommendation |
|---|---|---|---|
| Warfarin | Anticoagulant (Vitamin K antagonist) | Significantly increased risk of brain haemorrhage when combined with ARIA-H | Contraindicated – do not use together |
| DOACs (apixaban, rivaroxaban, dabigatran, edoxaban) | Direct oral anticoagulants | Increased risk of brain haemorrhage and worsening of ARIA-H | Contraindicated – do not use together |
| Heparin / LMWH (enoxaparin, dalteparin) | Injectable anticoagulant | Increased risk of brain bleeding | Contraindicated – do not use together |
| Thrombolytics (alteplase, tenecteplase) | Clot-dissolving agents | Greatly increased risk of serious brain haemorrhage | Use only in life-threatening emergencies; inform treating physician about Kisunla use |
Use with Caution
| Drug/Class | Category | Effect | Recommendation |
|---|---|---|---|
| Aspirin (low-dose, ≤325 mg/day) | Antiplatelet agent | May modestly increase risk of microhaemorrhages | May be continued under medical supervision; discuss with your neurologist |
| Clopidogrel, Prasugrel, Ticagrelor | P2Y12 inhibitor antiplatelets | Increased bleeding risk, particularly during ARIA episodes | Use only if benefit clearly outweighs risk; close monitoring required |
| NSAIDs (ibuprofen, naproxen) | Non-steroidal anti-inflammatory drugs | Mild antiplatelet effect; potential modest increase in bleeding risk | Short-term use generally acceptable; discuss chronic use with your doctor |
What Is the Correct Dosage of Kisunla?
Kisunla is administered as an intravenous infusion every 4 weeks with a gradual dose escalation: 350 mg at infusion 1, 700 mg at infusion 2, 1050 mg at infusion 3, followed by 1400 mg for subsequent infusions. Treatment should not exceed 18 months. An MRI must be performed before the 2nd, 3rd, 4th, and 7th infusions.
You will receive Kisunla under the supervision of a qualified healthcare professional. Before treatment begins, you must have had an MRI brain scan within the past 6 months, and your ApoE ε4 status must be determined through genetic testing.
Dose Titration Schedule
Treatment with Kisunla follows a carefully structured dose escalation programme designed to minimise the risk of ARIA. The following table outlines the infusion schedule:
| Infusion | Week | Dose | MRI Required Before |
|---|---|---|---|
| 1st | Week 0 | 350 mg | Baseline MRI (within 6 months) |
| 2nd | Week 4 | 700 mg | Yes |
| 3rd | Week 8 | 1050 mg | Yes |
| 4th | Week 12 | 1400 mg | Yes |
| 5th–6th | Week 16–20 | 1400 mg | No (routine) |
| 7th | Week 24 | 1400 mg | Yes |
| 8th–18th | Week 28–68 | 1400 mg | Before 12th dose if ApoE ε4 carrier or prior ARIA |
How It Is Given
Kisunla is administered as an intravenous (IV) infusion – a drip into a vein in your arm. Each infusion takes a minimum of 30 minutes. After each infusion, you will be monitored by healthcare staff for at least 30 minutes for signs of allergic or infusion-related reactions. The infusion must be prepared using aseptic technique in a healthcare setting by qualified personnel.
Before preparation, the vials should be allowed to reach room temperature for approximately 30 minutes. The concentrate is diluted in 0.9% sodium chloride solution to achieve a final concentration of approximately 4 mg/mL to 10 mg/mL. The solution should be clear and colourless to slightly yellow or slightly brown, and free of visible particles.
Treatment Duration
Your doctor will determine how long you should be treated with Kisunla based on your clinical response and amyloid PET scan results. The total treatment duration with Kisunla should not exceed 18 months. One of the unique features of Kisunla compared to other anti-amyloid therapies is the possibility of completing treatment once amyloid plaques have been sufficiently cleared, rather than requiring indefinite infusions. In the TRAILBLAZER-ALZ 2 trial, the median time to achieving amyloid-negative status was approximately 13 months.
Missed Dose
If you miss or forget an appointment for your Kisunla infusion, schedule a new appointment as soon as possible. Do not try to receive a double dose to make up for a missed infusion. Your doctor will advise you on the best course of action, which may include repeating an MRI before your next infusion depending on how much time has elapsed.
Overdose
As Kisunla is administered by healthcare professionals in a controlled clinical setting, overdose is unlikely. If you believe you have received too much Kisunla, contact your doctor immediately. In clinical trials, no specific toxicity was observed at doses above the recommended range, but overdose may theoretically increase the risk of ARIA.
What Are the Side Effects of Kisunla?
The most important side effects of Kisunla are amyloid-related imaging abnormalities (ARIA), including brain swelling (ARIA-E, very common) and brain microbleeds (ARIA-H, very common). Other side effects include headache (very common), infusion-related reactions (common), nausea, and vomiting. Serious cases of ARIA, including fatal outcomes, have occurred, primarily within the first 12 weeks of treatment.
Like all medicines, Kisunla can cause side effects, although not everybody gets them. The side effects are categorised below by how frequently they occur. It is critical that you report any new or worsening symptoms to your doctor promptly, particularly during the first six months of treatment.
Headache, confusion, nausea, vomiting, poor balance, dizziness, tremors, vision changes, speech difficulties, feeling unsteady, changes in consciousness, or seizures. These may indicate ARIA, which in some cases has been serious and fatal.
Very Common
May affect more than 1 in 10 people
- Brain swelling or fluid accumulation (ARIA-E)
- Brain microbleeds or iron deposits (ARIA-H)
- Headache
Common
May affect up to 1 in 10 people
- Nausea
- Vomiting
- Infusion-related reactions (flushing, chills, sweating, chest tightness, shortness of breath, blood pressure changes)
Uncommon
May affect up to 1 in 100 people
- Anaphylactic reaction (sudden, severe allergic reaction with breathing difficulties, swelling, rapid heartbeat, sweating, and loss of consciousness)
Understanding ARIA in Detail
ARIA is the most significant adverse effect associated with Kisunla and all anti-amyloid therapies. It is important to understand what ARIA is, how it is monitored, and what it means for your treatment.
ARIA-E (oedema/effusion) refers to the accumulation of fluid in the brain tissue or in the spaces surrounding the brain. In the TRAILBLAZER-ALZ 2 trial, ARIA-E occurred in approximately 24% of donanemab-treated patients. The majority of ARIA-E events were asymptomatic (detected only on routine MRI) and resolved within 12 weeks. When symptoms occurred, they most commonly included headache, confusion, and dizziness.
ARIA-H (haemorrhage) refers to microhaemorrhages (tiny bleeds) within the brain tissue or superficial siderosis (iron deposits from bleeding on the brain surface). ARIA-H was observed in approximately 31% of donanemab-treated patients in the clinical trial. Most ARIA-H events were radiographically mild and did not cause symptoms.
The risk of ARIA is highest during the first 24 weeks of treatment, particularly during the dose titration phase. Risk factors for ARIA include carrying one or more copies of the ApoE ε4 gene, the presence of pre-existing cerebral microhaemorrhages, and the total amount of amyloid cleared. Your doctor will carefully weigh these risk factors before initiating treatment and will monitor you closely with serial MRI scans.
Reporting Side Effects
It is important to report suspected side effects after the medicine has been approved. This makes it possible to continuously monitor the benefit-risk balance of the medicine. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority.
How Should You Store Kisunla?
Kisunla must be stored in a refrigerator (2°C–8°C) in its original packaging protected from light. It must not be frozen or shaken. Unopened vials may be stored at room temperature (up to 25°C) for up to 3 days. Kisunla is administered in a healthcare setting, so storage is handled by medical professionals.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton after “EXP.” The expiry date refers to the last day of that month.
The following storage conditions must be maintained:
- Refrigeration: Store at 2°C to 8°C (36°F to 46°F)
- Do not freeze: Freezing can denature the antibody protein and render the medicine ineffective
- Do not shake: Shaking can cause protein aggregation and degradation
- Protect from light: Store in the original packaging until ready for use
- Room temperature excursion: May be stored outside of the refrigerator for up to 3 days at temperatures not exceeding 25°C (77°F)
This medicine should not be used if it is cloudy or if visible particles are present. Any unused product or waste material should be disposed of by healthcare professionals in accordance with local requirements.
What Does Kisunla Contain?
Each vial of Kisunla contains 350 mg of donanemab in 20 mL of solution (17.5 mg/mL). Inactive ingredients include citric acid, polysorbate 80, sodium citrate, sucrose, and water for injections. The solution should be clear, colourless to slightly yellow or slightly brown.
The active substance is donanemab. Each glass vial contains 350 mg of donanemab in 20 mL of concentrate, providing a concentration of 17.5 mg/mL.
The other ingredients (excipients) are:
- Citric acid (E 330) – a buffering agent that maintains the pH of the solution
- Polysorbate 80 (E 433) – a surfactant that prevents protein aggregation and helps maintain the stability of the monoclonal antibody
- Sodium citrate (E 331) – a buffering agent that works together with citric acid
- Sucrose – a stabiliser that protects the protein during storage
- Water for injections – the solvent
Appearance and Packaging
Kisunla concentrate for solution for infusion is supplied in clear glass vials. The solution may vary in colour from colourless to slightly yellow or slightly brown. It is available in a pack of 1 vial and as a multipack of 2 (2 packs of 1) vials. Not all pack sizes may be marketed in your country.
For the preparation of a full maintenance dose (1400 mg), four vials are required. The total volume of 80 mL of concentrate is diluted in 0.9% sodium chloride solution for intravenous infusion. The final concentration after dilution ranges from approximately 4 mg/mL to 10 mg/mL, depending on the infusion bag size used.
Frequently Asked Questions About Kisunla
Kisunla (donanemab) is used to slow the progression of Alzheimer’s disease in adults with early symptomatic disease (mild cognitive impairment or mild dementia) who have confirmed amyloid beta plaque accumulation in the brain. It is a monoclonal antibody that targets and clears amyloid plaques. It is approved for patients who carry zero or one copy of the ApoE ε4 gene. Your doctor will confirm eligibility through brain imaging (amyloid PET scan or cerebrospinal fluid analysis) and genetic testing.
Kisunla differs from traditional Alzheimer’s medications (such as donepezil or memantine) in a fundamental way: it is a disease-modifying therapy that directly targets the underlying pathology by removing amyloid plaques, rather than simply managing symptoms. Unlike lecanemab (Leqembi), another anti-amyloid therapy, Kisunla has a time-limited treatment course of up to 18 months. Once amyloid plaques are sufficiently cleared, treatment can be stopped, whereas lecanemab requires ongoing biweekly infusions. In clinical trials, approximately 80% of patients on Kisunla achieved amyloid-negative status.
The most serious risk is amyloid-related imaging abnormalities (ARIA), which includes brain swelling (ARIA-E) and brain microbleeds (ARIA-H). While most ARIA cases are asymptomatic and detected only on routine MRI, some cases have led to serious symptoms including confusion, seizures, and visual disturbances. In rare cases, ARIA has been fatal, typically within the first 12 weeks of treatment. Risk is higher in ApoE ε4 carriers. Other serious risks include anaphylactic reactions (rare) and severe infusion-related reactions. Regular MRI monitoring is mandatory throughout treatment.
Kisunla treatment lasts up to a maximum of 18 months. The treatment follows a dose-escalation schedule over the first three infusions (350 mg, 700 mg, 1050 mg) given every 4 weeks, followed by a maintenance dose of 1400 mg every 4 weeks. Your doctor may decide to stop treatment earlier if amyloid PET scans show that your brain amyloid levels have reached a sufficiently low level. In the clinical trial, the median time to achieving amyloid-negative status was approximately 13 months. This time-limited approach is a key advantage of Kisunla compared to some other anti-amyloid therapies.
No. Anticoagulant medications (blood thinners such as warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, heparin, and low-molecular-weight heparins) are strictly contraindicated with Kisunla. The combination significantly increases the risk of serious brain haemorrhage, particularly in the context of ARIA-H. If you need anticoagulant therapy for another medical condition (such as atrial fibrillation or venous thromboembolism), Kisunla cannot be used. Low-dose aspirin may be continued under medical supervision, but this should be discussed with your neurologist.
ApoE ε4 is a variant of the apolipoprotein E gene. Everyone inherits two copies of the ApoE gene (one from each parent), and these can be the ε2, ε3, or ε4 variant. Carrying the ε4 variant increases the risk of developing Alzheimer’s disease and also increases the risk of ARIA side effects during anti-amyloid treatment. People with two copies (homozygous) face the highest risk. Kisunla is currently approved for patients with zero or one copy of ApoE ε4. Your doctor will perform a simple blood test to determine your ApoE genotype before prescribing Kisunla.
References and Sources
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Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, consisting of licensed specialist physicians in neurology, geriatric medicine, and clinical pharmacology with documented academic backgrounds and clinical experience in neurodegenerative diseases.
Content created by physicians specialising in neurology and clinical pharmacology, following international guidelines from the EMA, FDA, and WHO.
Reviewed by the iMedic Medical Review Board, an independent panel of medical experts ensuring accuracy and adherence to evidence-based standards.
All medical claims use the GRADE evidence framework. This article is based on Evidence Level 1A – systematic reviews and randomised controlled trials (TRAILBLAZER-ALZ 2).
iMedic receives no commercial funding or pharmaceutical sponsorship. All content is editorially independent and free from conflicts of interest.