Donanemab (don-an-e-mab), also called Kisunla, is a drug treatment for Alzheimer’s disease. It is made by the drug company Lilly.
It has been licensed for prescription in England, Scotland, and Wales for people with a confirmed diagnosis of:
mild or early-stage Alzheimer’s disease.
mild cognitive impairment who have high levels of a protein called amyloid in their brain.
Donanemab is not yet available on the NHS. In August 2024, it was rejected for use in NHS England and Wales. This decision was upheld in June 2025, ruling that it does not have a high enough benefit to justify the cost of funding it on the NHS.
Donanemab is the second drug licensed in Great Britain that targets one of the underlying disease processes that affects the brain in Alzheimer’s. It is designed to slow down the disease progression. Existing treatments like donepezil, rivastigmine, galantamine, and memantine can relieve some of the symptoms of Alzheimer’s but do not stop it from getting worse.
Donanemab is not a cure but may allow some people with early Alzheimer’s to live independently and with milder symptoms for longer by slowing the disease down.
Donanemab has not been approved to treat people with moderate to severe Alzheimer’s. There is currently no evidence that it can treat other types of dementia, such as vascular dementia, dementia with Lewy bodies, or frontotemporal dementia.
Treatment should be initiated and supervised by physicians experienced in the diagnosis and treatment of Alzheimer’s disease. The presence of amyloid beta (Aβ) pathology must be confirmed using approved methods such as amyloid Positron Emission Tomography (PET) scan or cerebrospinal fluid (CSF) analysis prior to initiating treatment. Testing for apolipoprotein E ε4 (ApoE ε4) status should be performed prior to initiation of treatment. The MHRA has decided to exclude people who carry two copies of the ApoE ε4 due to the increased risk of serious side effects.
Treatment should be initiated and supervised by physicians experienced in the diagnosis and treatment of Alzheimer’s disease. The presence of amyloid beta (Aβ) pathology must be confirmed using approved methods such as amyloid Positron Emission Tomography (PET) scan or cerebrospinal fluid (CSF) analysis prior to initiating treatment. Testing for apolipoprotein E ε4 (ApoE ε4) status should be performed prior to initiation of treatment. The MHRA has decided to exclude people who carry two copies of the ApoE ε4 due to the increased risk of serious side effects.
Donanemab is a type of drug called a disease-modifying monoclonal antibody.
Antibodies form part of our immune system and bind to harmful proteins to destroy and remove them. Donanemab contains antibodies that bind to a protein called amyloid, which builds up in the brains of people with Alzheimer’s. Although our bodies naturally produce antibodies, the specific anti-amyloid antibodies used in this treatment are created in a laboratory. Other drugs for Alzheimer’s disease, like donepezil, rivastigmine, galantamine, and memantine, are known as 'symptomatic’ treatments. These allow our brain cells to communicate better and mask the damage caused by diseases like Alzheimer’s for a time. Although symptomatic treatments can make a big difference to somebody’s quality of life, they can’t slow or stop Alzheimer’s from getting worse. By directly targeting amyloid, donanemab can slow down the disease process. You may be prescribed a symptomatic treatment and donanemab at the same time. There is no evidence for any negative side effects when used in combination.
Donanemab has been shown in clinical trials to slow down decline in memory and thinking problems for people with mild Alzheimer’s disease and improve quality of life. Data from the trial shows that Donanemab slowed down memory and thinking getting worse. Among participants with early symptomatic Alzheimer's disease and amyloid and tau pathology, donanemab significantly slowed clinical progression at 76 weeks in those with low/medium tau and in the combined low/medium and high tau pathology population
There is no evidence that donanemab can restore lost memories or make symptoms go away completely. The aim of treatment is that your symptoms decline less over time. This could allow you to live independently for longer. Researchers estimate that over 18 months the drug may slow the progression of the condition by around four to seven months.
The medicines you take for other conditions and your health history may affect whether you can take Donanemab. Use of Donanemab in patients who are on anticoagulants (blood thinners, including warfarin) or have been diagnosed with cerebral amyloid angiopathy
(CAA) on MRI before starting treatment is contraindicated as the risks in these patients are considered to outweigh the benefits. History of stroke or seizures within 12 months of screening is also contraindicated. Also, it would not be appropriate to have it if you are allergic to Donanemab or any of the other ingredients in it or if your MRI brain scan shows small spots of bleeding or fluid in the brain or evidence of larger bleeding in the past.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before you are given this medicine. It is not known if donanemab will harm your unborn baby or if this medicine passes into breast milk. If you become pregnant while you are using donanemab, tell your doctor. You and your doctor can discuss if you should carry on with treatment.
If you are breastfeeding, you and your doctor can discuss if you should carry on with breastfeeding or treatment.
Using contraception
Women of childbearing potential must use effective contraception during and up to three months after treatment.
All treatments and procedures have risks, and we will talk to you about the risks of Donanemab. The main risks are:
Infusion-related reactions (IRR)
Some people taking donanemab have reactions related to the drug being given into the vein. These are called ‘infusion-related reactions’ (IRR) and can happen with many drugs given in this way, e.g., drugs given for cancer.
When something new is injected into your body, your immune system tries to fight it. Usually, this keeps us safe from harmful viruses and bacteria. But our immune system doesn’t know that donanemab is trying to help us. This can produce symptoms such as fever, redness, and itch.
You may be prescribed medicines to help prevent this reaction, such as paracetamol, antihistamines, or steroids.
Around one in four people taking donanemab in trials experienced infusion-related reactions. Of these, three out of every four people did so only during their first appointment.
ARIA
Donanemab can also cause a side effect called "ARIA", or amyloid-related imaging abnormalities.
These are brain changes, including swelling (ARIA-E) and bleeding (ARIA-H) within the brain, which are seen on MRI brain scans. While for the most part these are not associated with symptoms or adverse outcomes, they can in some cases become serious.
In trials of the drug, roughly 30% of people developed ARIA. However, most people (four in every five) who developed ARIA did not have symptoms. In a second trial, a change in the initiation of donanemab dosing to a more graduated initial dosing regimen lowered ARIA-E rates compared to the standard dosing regimen used in the original clinical trial, without changing the overall amount of donanemab received by each patient.
Symptoms of ARIA may include:
headache
confusion
dizziness
vision changes
nausea
difficulty walking
seizures
There were three deaths related to taking donanemab in clinical trials (0.4%). As with any medicine, the MHRA will keep the safety and effectiveness of donanemab under close review. Initiation of treatment will be through a central registration system implemented as part of a controlled access programme. A controlled post-authorization safety study will be conducted to investigate the safety and benefit-risk profile of donanemab in routine clinical practice, particularly in relation to incidence and severity of ARIAs and intracerebral haemorrhage, and long-term safety.
You will have to undergo MRI scans prior to the 2nd, 4th, and 7th infusions of donanemab. Additionally, an MRI scan is recommended at week 52. There may also be a need for additional MRI scans in cases where there is evidence of ARIA on a planned MRI scan. If you experience ARIA, the severity will dictate your course of treatment. In mild cases where ARIA-E or ARIA-H are detected on MRI but you are not experiencing any symptoms, it is likely you can continue with your regular Donanemab infusions, but there will be a need for monthly MRIs until the ARIA resolves or stabilises. In moderate to severe cases of ARIA, it will be necessary to pause donanemab until there is resolution/stabilisation and in instances of severe ARIA-H, the recommendation is that Donanemab is stopped permanently.
It is particularly important that patients being treated with donanemab carry a Patient Alert Card at all times to alert medical staff to this fact. This card includes information on the prescribing service’s 24-hour contact details and highlights important safety information. Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor or clinical nurse specialist. However, if you experience any of the symptoms above that cause you to feel acutely unwell, you should call 999 or go to the nearest A&E as soon as possible. It’s important to get these symptoms checked quickly and to let any doctor you see know that you are taking this medication.
If you choose not to take Donanemab, you will be offered the standard course of symptomatic treatment, such as donepezil, rivastigmine, galantamine, and memantine.
There is one other disease-modifying drug approved for use in the UK called Lecanemab. There are 127 drugs currently in clinical trials.
Your doctor will discuss with you if Donanemab is appropriate for you. Following the screening process (clinical history and examination, cognitive testing, imaging, biomarkers (PET scan or lumbar puncture), and APOE testing). It is important that you understand you will need to attend the hospital every four weeks to receive an infusion and undergo MRI scans prior to the 2nd, 4th, and 7th infusions of Donanemab. Additionally, an MRI scan is recommended at 1 year.
We would also strongly recommend a care partner or family member accompany you on all visits and be with you afterwards should you feel unwell.
We want to involve you in all the decisions about your care and treatment. If you decide to go ahead with treatment, by law we must ask for your consent and will ask you to sign a consent form. This confirms that you agree to have the procedure and understand what it involves. Staff will explain all the risks, benefits, and alternatives before they ask you to sign a consent form. If you are unsure about any aspect of your proposed treatment, please speak with a senior staff member.
Patients, care partners, and appropriate family members should understand the requirements for Donanemab therapy and the potential benefit and potential harm of treatment
You can eat and drink as normal prior to an infusion and take your medications as normal. You will be given a time to attend the ward. You will be seen by a clinical nurse specialist prior to the infusion to ensure it is safe for you to receive the infusion.
An IV cannula will be placed in a vein in your arm. You will then be connected to an intravenous drip of donanemab. Each infusion is given over at least 30 minutes. Your blood pressure, heart rate, temperature, and respiratory rate will be monitored regularly during the infusion and afterwards. After the first four infusions, you will need to remain on the ward for an observation time of one hour. This is reduced to 30 minutes thereafter, provided you have not experienced any infusion reactions. The cannula will be removed before you leave the ward, and you will be given the date for your next infusion. You will be able to use public transport to go home, provided you feel well enough to do so.
A clinical nurse specialist will call you the day after your infusion to see how you are. You will be provided with their contact details if you have questions regarding your treatment. You may be advised to take regular paracetamol and antihistamine if you experience any infusion-related reactions.
Donanemab has no or negligible influence on the ability to drive and use machines. Though please avoid driving or operating machinery if you experience dizziness or confusion during treatment with donanemab.
Your team will arrange MRI scans before your 2nd, 4th, and 7th doses of donanemab. This is routine monitoring to check if you have ARIA. Additional scans can be performed at other times during treatment if your doctor thinks you need them. Your treatment may be stopped temporarily, depending on your MRI results. If you miss an infusion of donanemab, talk to your team to arrange to have it as soon as possible. Do not wait until your next planned infusion.
- Alzheimer's Association (2024) 'Approved for Treatment of Early Alzheimer's'. Available at: https://
www. alz.org/ alzheimers-dementia/ treatments/ donanemab - GOV.UK (2024) Donanemab licensed for early stages of Alzheimer’s disease in adult patients who have one or no copies of apolipoprotein E4 gene. Available at: https://
www. gov.uk/ government/ news/ donanemab-licensed-for-early-stages-of-alzheimers-disease-in-adult-patients-who-have-one-or-no-copies-of-apolipoprotein-e4-gene -
Alzheimer's Research UK (2024) 'Donanemab – What is it and how does it work?', Alzheimer's Research UK. Available at: https://
www. alzheimersresearchuk.org/ news/ new-alzheimers-drug-donanemab-what-is-it-and-how-does-it-work/
Page last updated: 14 August 2025
Review due: 11 August 2027