Donanemab is an active pharmaceutical ingredient in the Other Anti-Dementia Drugs group (N06DX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
USOfficial regulatory label· revised December 30, 2025[1]
1 INDICATIONS AND USAGE KISUNLA TM is indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials.
KISUNLA is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials.
( 1 )
How to take
GBUnited Kingdom· MHRA
1 product
Uses
GBOfficial regulatory label· revised April 24, 2026[2]
1).
How to take
GBOfficial regulatory label· revised April 24, 2026
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised February 26, 2026[3]
4).
How to take
EUOfficial regulatory label· revised February 26, 2026
CACanada· Health Canada
1 product
1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [4].
[1]FDA DailyMed · 190352d4-ef62-46… · revised December 30, 2025 [PDF]
[2]MHRA (UK) · PLGB148950338 · revised April 24, 2026
[3]European Medicines Agency · EMEA/H/C/006024 · revised February 26, 2026
[4]Health Canada (DPD) · 02567725 · revised May 27, 2026
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
USOfficial regulatory label· revised December 30, 2025[1]
2 DOSAGE AND ADMINISTRATION Confirm the presence of amyloid beta pathology prior to initiating treatment. 2 ): Infusion 1: 350 mg Infusion 2: 700 mg Infusion 3: 1,050 mg Infusion 4 and beyond: 1,400 mg Consider stopping dosing with KISUNLA based on reduction of amyloid plaques to minimal levels on amyloid PET imaging.
2 ) Obtain a recent baseline brain MRI prior to initiating treatment. 1 ) Obtain an MRI prior to the 2nd, 3rd, 4th, and 7th infusions. If radiographically observed ARIA occurs, treatment recommendations are based on type, severity, and presence of symptoms.
9% Sodium Chloride Injection, is required prior to administration. 1 )] . 2 Dosing Instructions Administer KISUNLA every four weeks as an intravenous infusion over approximately 30 minutes with the recommended dosage and dosing schedule described in Table 1 .
KISUNLA must be diluted prior to administration ( see Table 4 ). 1 ) and Clinical Studies ( 14 )] Intravenous Infusion (every 4 weeks) KISUNLA Dosage (administered over approximately 30 minutes) Infusion 1 350 mg Infusion 2 700 mg Infusion 3 1,050 mg Infusion 4 and beyond 1,400 mg Consider stopping dosing with KISUNLA based on reduction of amyloid plaques to minimal levels on amyloid PET imaging.
In Study 1 and Study 2, dosing was stopped based on a reduction of amyloid levels below predefined thresholds on PET imaging [see Clinical Studies ( 14 )] . If an infusion is missed, resume administration every 4 weeks at the same dose as soon as possible.
1 )] . Monitoring for ARIA Obtain a recent baseline brain magnetic resonance imaging (MRI) prior to initiating treatment with KISUNLA. Obtain an MRI prior to the 2 nd , 3 rd , 4 th , and 7 th infusions. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including an MRI if indicated.
Recommendations for Dosing Interruptions in Patients with ARIA ARIA-E The recommendations for dosing interruptions for patients with ARIA-E are provided in Table 2 .
Table 2:
Dosing Recommendations for Patients With ARIA-E c a Mild: discomfort noticed, but no disruption of normal daily activity. Moderate: discomfort sufficient to reduce or affect normal daily activity. Severe: incapacitating, with inability to work or to perform normal daily activity.
b Suspend until MRI demonstrates radiographic resolution and symptoms, if present, resolve; consider a follow-up MRI to assess for resolution 2 to 4 months after initial identification. Resumption of dosing should be guided by clinical judgment.
1 )] . Clinical Symptom Severity a ARIA-E Severity on MRI Mild Moderate Severe Asymptomatic May continue dosing at current dose and schedule Suspend dosing b Suspend dosing b Mild May continue dosing based on clinical judgment Suspend dosing b Moderate or Severe Suspend dosing b ARIA-H The recommendations for dosing interruptions for patients with ARIA-H are provided in Table 3 .
Table 3:
Dosing Recommendations for Patients With ARIA-H c a Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve; resumption of dosing should be guided by clinical judgment; consider a follow-up MRI to assess for stabilization 2 to 4 months after initial identification.
b Suspend until MRI demonstrates radiographic stabilization and symptoms, if present, resolve. Use clinical judgment when considering whether to continue treatment or permanently discontinue KISUNLA. 1 )] . Clinical Symptom Severity ARIA-H Severity on MRI Mild Moderate Severe Asymptomatic May continue dosing at current dose and schedule Suspend dosing a Suspend dosing b Symptomatic Suspend dosing a Suspend dosing a In patients who develop intracerebral hemorrhage greater than 1 cm in diameter during treatment with KISUNLA, suspend dosing until MRI demonstrates radiographic stabilization and symptoms, if present, resolve.
Use clinical judgment when considering whether to continue treatment or permanently discontinue KISUNLA after radiographic stabilization and resolution of symptoms. 9% sodium chloride injection ( see Table 4 ). Use aseptic technique when preparing the diluted KISUNLA solution for intravenous infusion.
Allow KISUNLA to equilibrate to room temperature before preparation. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. KISUNLA solution is clear to opalescent, colorless to slightly yellow to slightly brown.
Do not use if particulate matter or discolorations are present. 9% sodium chloride injection, to the recommended total volume for a final concentration of 4 mg/mL to 10 mg/mL ( see Table 4 ). 9% sodium chloride injection for dilution.
5 mL (4 mg/mL) to 1,050 mg/105 mL (10 mg/mL) 1,400 mg 80 mL d 60 mL to 270 mL 140 mL to 350 mL 1,400 mg/350 mL (4 mg/mL) to 1,400 mg/140 mL (10 mg/mL) Each vial is for one-time use only. Discard any unused portion left in the vial. Gently invert the diluted KISUNLA solution to mix completely.
Do not shake. After dilution, immediate use is recommended [see Description ( 11 )] . If the diluted KISUNLA solution is not administered immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 72 hours or at room temperature (20°C to 25°C [68°F to 77°F]) for up to 12 hours.
Do not freeze the diluted KISUNLA solution. Storage times include the duration of infusion. 5 Administration Instructions Visually inspect the diluted KISUNLA solution for particles or discoloration prior to administration. Do not use if it is discolored, or opaque or foreign particles are seen.
Prior to infusion, if the diluted solution has been stored under refrigeration, allow the diluted KISUNLA solution to warm to room temperature. Administer the entire diluted solution intravenously over approximately 30 minutes. 9% sodium chloride injection at the end of the infusion per access specific line maintenance protocol.
Observe the patient post-infusion for a minimum of 30 minutes, and consider longer periods of observation if clinically indicated, to evaluate for infusion reactions and hypersensitivity reactions. The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy administered as clinically indicated.
2 )] .
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 1,482 reports total. [5]
Amyloid Related Imaging Abnormality-Oedema/Effusion 247
Amyloid Related Imaging Abnormality-Microhaemorrhages And Haemosiderin Deposits 184
Infusion Related Reaction 167
Headache 121
Flushing 110
Amyloid Related Imaging Abnormalities 84
Cerebral Haemorrhage 73
Dizziness 71
Nausea 69
Dyspnoea 62
Blood Pressure Increased 48
Cerebral Microhaemorrhage 48
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised December 30, 2025[1]
3 )] Most common adverse reactions (at least 10% and higher incidence compared to placebo): ARIA-E, ARIA-H microhemorrhage, ARIA-H superficial siderosis, and headache. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
2 ), Clinical Studies ( 14 )] . The safety of KISUNLA has been evaluated in 3727 patients with Alzheimer's disease who received at least one dose of KISUNLA intravenously. In the other clinical studies of KISUNLA, 1912 patients with Alzheimer's disease received KISUNLA once monthly for at least 6 months, 1057 patients for at least 12 months, and 432 patients for at least 18 months, at the Dosing Regimen 1.
Study 1 In Study 1 (NCT04437511), a total of 853 patients with Alzheimer's disease received at least one dose of KISUNLA; patients were randomized to receive KISUNLA Dosing Regimen 1 or placebo. Thirteen percent of patients treated with KISUNLA compared to 4% of patients on placebo stopped study treatment because of an adverse reaction.
The most common adverse reaction leading to discontinuation of KISUNLA was infusion-related reaction (4% of patients treated with KISUNLA compared to no patient on placebo). Table 7 shows adverse reactions that were reported in at least 5% of patients treated with KISUNLA and at least 2% more frequently than in patients on placebo in Study 1.
Table 7:
Adverse Reactions Reported in at Least 5% of Patients Treated With KISUNLA and at Least 2% Higher Than Placebo in Study 1 a Administered as a different titration regimen (700 mg/700 mg/700 mg/1,400 mg) than the currently recommended dosing regimen (350 mg/700 mg/1,050 mg/1,400 mg) b As assessed by MRI.
A participant could have both microhemorrhage and superficial siderosis. 5 Study 2 In Study 2 (NCT05738486), a total of 842 patients received at least one dose of KISUNLA; 212 patients were randomized to receive KISUNLA Dosing Regimen 2.
1 ) and Clinical Studies ( 14 )]. 7% of patients on placebo in Study 1 and in 8% of patients treated with KISUNLA Dosing Regimen 2 in Study 2. 5%) treated with KISUNLA Dosing Regimen 2 in Study 2. 1%) on placebo in Study 1. 6 )] Infusion-related reactions occurred more frequently in patients treated with KISUNLA who developed anti-drug antibodies (ADAs) compared to patients who did not develop ADAs (Study 1, Dosing Regimen 1: 10% compared to 2%; Study 2, Dosing Regimen 2: 20% compared to 8%).
USOfficial regulatory label· Warnings and precautions· revised December 30, 2025[1]
5 WARNINGS AND PRECAUTIONS Amyloid Related Imaging Abnormalities (ARIA): Enhanced clinical vigilance for ARIA is recommended during the first 24 weeks of treatment with KISUNLA. Risk of ARIA, including symptomatic ARIA, was increased in apolipoprotein E ε4 (ApoE ε4) homozygotes compared to heterozygotes and noncarriers.
The risk of ARIA-E and ARIA-H is increased in KISUNLA-treated patients with pretreatment microhemorrhages and/or superficial siderosis. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI scanning if indicated.
1 ) Infusion-Related Reactions: The infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Consider pre-treatment with antihistamines, acetaminophen, or corticosteroids prior to subsequent dosing.
1 Amyloid Related Imaging Abnormalities Monoclonal antibodies directed against aggregated forms of beta amyloid, including KISUNLA, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E), which can be observed on MRI as brain edema or sulcal effusions, and ARIA with hemosiderin deposition (ARIA-H), which includes microhemorrhage and superficial siderosis.
ARIA can occur spontaneously in patients with Alzheimer's disease, particularly in patients with MRI findings suggestive of cerebral amyloid angiopathy, such as pretreatment microhemorrhage or superficial siderosis. ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta amyloid generally occurs in association with an occurrence of ARIA-E.
ARIA-H of any cause and ARIA-E can occur together. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur. ARIA can be fatal.
When present, reported symptoms associated with ARIA may include, but are not limited to, headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms associated with ARIA usually resolve over time.
In addition to ARIA, intracerebral hemorrhages greater than 1 cm in diameter have occurred in patients treated with KISUNLA. Consider the benefit of KISUNLA for the treatment of Alzheimer's disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with KISUNLA.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised December 30, 2025[1]
4 CONTRAINDICATIONS KISUNLA is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients. 2 )] . KISUNLA is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or to any of the excipients.
2 )
This is not medical advice. Consult a qualified healthcare professional.
Treatment should be initiated by a physician experienced in the diagnosis and treatment of Alzheimer’s disease. 4). 1). 1). Prior to testing patients should be appropriately counselled and consented according to national or local guidelines, as applicable.
Posology The recommended dose of donanemab is 700 mg every 4 weeks for the first 3 doses, followed by 1400 mg every 4 weeks. 1). 1). 1). The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis. If patient progress to moderate Alzheimer’s disease before the end of the 18 months maximum treatment, donanemab should be stopped.
Monitoring for Amyloid Related Imaging Abnormalities (ARIA) Donanemab can cause amyloid related imaging abnormalities-oedema (ARIA-E) and -haemosiderin deposition (ARIA-H), see section
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 24, 2026[2]
). These reactions may be severe or life-threatening and typically occur during infusion or within 30 minutes post infusion. Signs and symptoms of infusion-related reactions may include erythema, chills, nausea, vomiting, sweating, headache, chest tightness, dyspnoea, and changes in blood pressure.
Appropriate resources for the management of severe reactions such as serious IRR, hypersensitivity reactions and/or anaphylactic reactions should be available. Reducing infusion rate, use of premedication or symptomatic treatment may be helpful in managing these reactions.
Administration of donanemab should be discontinued immediately and appropriate treatment should be initiated in case of serious infusion-related reactions or as clinically indicated. Higher ADA titre was associated with increased incidence of infusion-related reactions.
Amyloid-related imaging abnormalities (ARIA) ARIA has been observed very commonly in donanemab clinical studies. ARIA usually occurs early in treatment and is usually asymptomatic. 8 Undesirable Effects). ARIA includes amyloid-related imaging abnormalities-oedema/effusions (ARIA-E; also known as cerebral vasogenic oedema) and amyloid-related imaging abnormalities haemorrhage/haemosiderin deposition (ARIA-H; includes cerebral microhaemorrhage and cortical superficial siderosis).
ARIA can be detected by MRI. Most ARIA events were first observed within 24 weeks of initiation of treatment. Access to MRI should be available during the treatment period of donanemab. 2). Additional MRI is indicated if ARIA symptoms occur.
Symptoms may include headache, confusion, nausea, vomiting, unsteadiness, dizziness, tremor, visual disturbances, speech disturbances, worsening cognitive function, alteration of consciousness, and seizures. Most serious ARIA events occurred within 12 weeks of initiation of treatment and an additional MRI prior to the third dose may aid in earlier detection of ARIA, particularly for patients with ARIA risk factors such as apolipoprotein E ε4 allele (APOE ε4) carriers, baseline cerebral microhaemorrhages and superficial siderosis.
8). Donanemab is not indicated for use in patients who are ApoE ε4 homozygotes. A higher frequency of ARIA has also been observed in patients with pre-treatment cerebral microhaemorrhage and/or superficial siderosis. Caution should be exercised when initiating donanemab treatment in patients with baseline risk factors.
3). 2% (2/999) of placebo-treated patients. 3). Recommendations for Dosing Interruptions in Patients with ARIA When ARIA-H does occur, it is often in the presence of ARIA-E and managed as for ARIA-E. 2). Radiographic Severity The radiographic severity of ARIA associated with donanemab was classified by the criteria shown in Table 2.
Table 2:
ARIA MRI Classification criteria Radiographic SeverityARIA Type Mild Moderate Severe ARIA-E FLAIR hyperintensity confined to sulcus and/or cortex/subcortex white matter in one location < 5 cm. FLAIR hyperintensity 5 to 10 cm in single greatest dimension, or more than 1 site of involvement, each measuring < 10 cm.
FLAIR hyperintensity > 10 cm with associated gyral swelling and sulcal effacement. One or more separate/independent sites of involvement may be noted. ARIA-H microhaemorrhage ≤ 4 new incident microhaemorrhages 5 - 9 new incident microhaemorrhages ≥ 10 new incident microhaemorrhages ARIA-H superficial siderosisa 1 new focal area of superficial siderosis 2 new focal areas of superficial siderosis > 2 new focal areas of superficial siderosis Abbreviations: FLAIR = fluid-attenuated inversion recovery; ARIA-E = amyloid- related imaging abnormalities-oedema/effusions; ARIA-H = amyloid-related imaging abnormalities haemorrhage/hemosiderin deposition a Includes new or increased focal areas of superficial siderosis Concomitant antithrombotic treatment The majority of exposures to antithrombotic medicines were to acetylsalicylic acid (81%) and more than 20% were treated with anticoagulants.
Patients who received donanemab and an antithrombotic medicine (acetylsalicylic acid, other antiplatelets, or anticoagulants), did not have an increased frequency of ARIA. The number of events and the limited exposure to other non-acetylsalicylic acid antithrombotic medicines limit definitive conclusions about the risk of ARIA or intracerebral haemorrhage in patients taking antithrombotic medicines.
, tissue plasminogen activator) to a patient already being treated with donanemab. • If anticoagulation needs to be commenced during therapy with donanemab (for example incident arterial thromboses, acute pulmonary embolism or other life- threatening […]
GBOfficial regulatory label· Warnings and precautions· revised April 24, 2026[2]
4. Access to MRI should be available during the treatment period of donanemab. Obtain a recent (within 1 year) brain magnetic resonance imaging (MRI) prior to initiating treatment. 4). For patients with radiographic findings of ARIA-E and ARIA-H, enhanced clinical vigilance for symptoms of ARIA is recommended.
4). The recommendations for dosing interruptions or treatment discontinuation for patients with amyloid-related imaging abnormalities-oedema/effusions (ARIA-E) and amyloid-related imaging abnormalities haemorrhage/haemosiderin deposition (ARIA- H) are provided in Table 1.
Table 1:
Dosing recommendations for patients with ARIA-E and ARIA-H ARIA-E and ARIA-H Severitya on MRI Clinical Symptom Mild Moderate Severe Asymptomatic Consider suspending dosing Suspend dosing Suspend dosing Symptomatic Suspend dosing aSee Table 2 for ARIA MRI radiographic severity classification Evaluation of risk factors again prior to restarting is recommended.
Supportive treatment, including corticosteroids may be considered in case of ARIA-E. ARIA-E Dosing may continue in asymptomatic, mild radiographic ARIA-E cases based on clinical judgement and with enhanced clinical monitoring and follow-up MRI scans starting two months after occurrence and every 1 or 2 months thereafter until ARIA-E has resolved.
Suspend dosing for any symptomatic or radiographically moderate or severe ARIA-E. A follow-up MRI to assess for resolution 2 to 4 months after initial identification should be performed. 4), if present, resolve, resumption of dosing should be guided by clinical judgment.
8). ARIA-H Dosing may continue in asymptomatic, mild radiographic ARIA-H cases based on clinical judgement and with enhanced clinical monitoring and follow-up MRI scans starting two months after occurrence and every 1 or 2 months thereafter until ARIA- H has stabilised.
Suspend dosing for any symptomatic or radiographically moderate or severe ARIA- H. A follow-up MRI to assess for resolution 2 to 4 months after initial identification should be performed. 4), if present, resolve, resumption of dosing should be guided by clinical judgment.
8). If a second event of radiographically severe ARIA-H occurs, use clinical judgement in considering whether to restart or permanently discontinue treatment with donanemab. 4). Method of administration Kisunla 350 mg is for intravenous infusion only.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 24, 2026[2]
1. Imaging findings suggestive of Cerebral Amyloid Angiopathy (CAA) that increase the risk of ARIA or intracerebral haemorrhage: - Acute or subacute cerebral haemorrhage - Superficial siderosis - More than 4 microhaemorrhages (defined as ≤ 1 cm in diameter on the T2* sequence) - Severe white matter disease - Pre-treatment MRI showing ARIA-E - Previous cerebral haemorrhage (defined as > 1 cm diameter in the T2* sequence) or previous subarachnoid haemorrhage unless it is no longer at risk of re- bleeding.
- Any finding that could prevent a satisfactory MRI evaluation for safety monitoring. 4).
This is not medical advice. Consult a qualified healthcare professional.
Treatment should be initiated by a physician experienced in the diagnosis and treatment of Alzheimer’s disease (AD) with timely access to Magnetic Resonance Imaging (MRI). Donanemab should be administered under the supervision of a multidisciplinary team trained in detection, monitoring and management of amyloid-related imaging abnormalities (ARIA) and experienced in detecting and managing infusion related reactions (IRR).
Patients treated with donanemab must be given the patient card and be informed about the risks of donanemab (see also package leaflet). ApoE ε4 Testing ApoE ε4 genotype should be assessed by a CE-marked in vitro diagnostic (IVD) with the corresponding intended purpose.
1). 4). Prior to testing patients should be appropriately counselled and consented according to national or local guidelines, as applicable. g. positron emission tomography [PET] scan, cerebrospinal fluid [CSF] or another appropriate test).
Donanemab should be administered every 4 weeks. The recommended dose of donanemab is 350 mg for the first dose, 700 mg for the second dose, 1 050 mg for the third dose, followed by 1 400 mg every 4 weeks. g. 1) as confirmed using a validated method.
The maximum treatment duration is 18 months which should not be exceeded even if plaque clearance is not confirmed. The benefit-risk of treatment should be reassessed at regular intervals on an individual basis and considering the rate of disease progression.
Consideration should be given to discontinuing treatment before the end of the 18 months maximum treatment if patients progress to moderate AD. Missed dose If an infusion is missed, administration should be resumed every 4 weeks at the same dose as soon as possible.
Monitoring, dosing interruption, and treatment discontinuation for amyloid related imaging abnormalities Donanemab can cause ARIA, characterized as ARIA with oedema (ARIA-E), which can be observed on MRI as brain oedema or sulcal effusions, and ARIA with haemosiderin deposition (ARIA-H), which includes microhaemorrhage and superficial siderosis.
In addition to ARIA, intracerebral haemorrhages greater than 1 cm in diameter have occurred in patients treated with donanemab. A recent (within 6 months) brain MRI should be available prior to initiating treatment with donanemab to evaluate for pre-existing ARIA.
An MRI should be performed prior to the second dose (at 1 month), prior to the third dose (at 2 months), prior to the fourth dose (at 3 months), and prior to the seventh dose (at 6 months). An additional MRI at one year of treatment (prior to the twelfth dose) in patients with ARIA risk factors such as ApoE ε4 heterozygotes, and/or patients with previous ARIA events earlier in treatment, should be performed.
4). The recommendations for dosing interruptions or treatment discontinuation for patients with ARIA-E and ARIA-H are provided in Table 1.
Table 1:
Dosing recommendations for patients with ARIA-E and ARIA-H Clinical symptom ARIA-E and ARIA-H severitya on MRI Mild Moderate Severe Asymptomatic Consider suspending dosing Suspend dosing Discontinue dosing Symptomatic Suspend dosing Suspend dosing Discontinue dosing aSee Table 2 for ARIA MRI radiographic severity classification criteria 4 In case of asymptomatic mild ARIA, consider dose suspension based on radiological features of ARIA, number of ARIA episodes and clinical condition.
In case of asymptomatic moderate ARIA and symptomatic mild/moderate ARIA, suspend dose until MRI demonstrates radiographic resolution (ARIA-E) or stabilisation (ARIA-H) and symptoms, if present, resolve. A follow-up MRI to assess for resolution (ARIA-E) or stabilization (ARIA-H) should be performed 2 to 4 months after initial identification.
4). 8). In the event of radiographically or symptomatic severe ARIA-E or ARIA-H, treatment with donanemab should be permanently discontinued. Donanemab should also be permanently discontinued after clinically serious ARIA-E, serious ARIA- H, or intracerebral haemorrhage greater than 1 cm.
Clinical judgment should be used in considering whether to continue dosing in patients with recurrent ARIA. Treatment with donanemab should be discontinued following recurrent symptomatic or radiographically moderate or severe ARIA events.
2). Paediatric population There is no relevant use of donanemab in the paediatric population for the treatment of Alzheimer’s disease. Method of administration Donanemab is for intravenous use only. Each vial is for single use only. Diluted solution should be administered over a period of at least 30 minutes.
Patients should be observed post-infusion for a minimum of 30 minutes. 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised February 26, 2026[3]
1), a total of 853 adult subjects received at least one dose of donanemab. Of these, 710 participants concerned the indicated population (ApoE ε4 heterozygotes and non-carriers). 8 % (143/853) were homozygotes. With the exception of events of ARIA, the safety profile was similar across genotypes.
6 %). 4 %). 4). Tabulated list of adverse reactions Adverse reactions from clinical studies with donanemab (Table 3) are listed by MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.
In addition, the corresponding frequency category for each reaction is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).
Table 3. Adverse reactions System organ class Very common Common Uncommon Nervous system disorders ARIA-Ea,b ARIA-Ha,b Microhaemorrhage Superficial siderosis Headache Intracranial haemorrhagec Gastrointestinal disorders Nausea Vomiting Injury, poisoning and procedural complications Infusion-related reactiond Hypersensitivity Anaphylactic reaction a As assessed by MRI.
b Symptoms may include headache, confusion, nausea, vomiting, unsteadiness, dizziness, tremor, visual disturbances, speech disturbances, worsening cognitive function, alteration of consciousness, and seizures. c Includes subdural haematoma, subarachnoid haemorrhage, cerebral haemorrhage, haemorrhagic stroke and cerebrovascular accident.
d Signs and symptoms of infusion-related reactions and hypersensitivity may include erythema, chills, nausea, vomiting, sweating, headache, chest tightness, dyspnoea, and changes in blood pressure. 5 % (98/728) of heterozygotes and non-carrier patients on placebo.
4 % (10/710) of patients treated with donanemab. 4 %, three patients). Clinical symptoms associated with ARIA-E resolved in approximately 80 % of patients. ARIA-E symptoms may include headache, confusion, nausea, vomiting, unsteadiness, dizziness, tremor, visual disturbances, speech disturbances, worsening cognitive function, alteration of consciousness, and seizures.
8 % (13/728) of patients on placebo. 4 % (10/710) of patients. 6 % (40/710) of patients treated with donanemab in the pivotal study. 3 weeks. 3 % (35/144) experienced multiple episodes of ARIA-E. 2 % (89/728) of patients on placebo. 6 % (54/710) of patients.
3 % (2/728) of patients on placebo. 5 % (84/728) on placebo. 9 % (70/195) of participants experienced multiple episodes of ARIA-H. The majority of first ARIA radiographic events in the placebo-controlled studies occurred early in treatment (within 24 weeks of initiation of treatment), although ARIA can occur at any time and patients can have more than one episode.
Standard supportive treatment, including corticosteroids may be considered in case of ARIA-E, however the effectiveness of treatment has not been established. 8 % (6/728) of patients on placebo. 3 % (2/728) in placebo treated patients.
Additionally, in a participant with baseline superficial siderosis treated with donanemab in the pivotal study, fatal ARIA-H was reported with concurrent intracerebral haemorrhage. 7 % donanemab vs. 6 % donanemab vs. 1 […]
EUOfficial regulatory label· Warnings and precautions· revised February 26, 2026[3]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Controlled access programme In order to promote the safe and effective use of donanemab, initiation of treatment in all patients should be through a central registration system implemented as part of a controlled access programme.
Educational materials Prescribers should be familiar with the educational material prepared for the detection and management of ARIA, and discuss the benefits and risks of donanemab therapy with the patient/caregiver. MRI scans and signs or symptoms of adverse reactions, and when to seek attention from a healthcare professional must also be discussed with the patient.
The patient will be provided with the patient card and instructed to carry the card at all times. Amyloid beta pathology The presence of amyloid beta pathology must be confirmed via an appropriate test prior to initiating treatment.
Amyloid-related imaging abnormalities (ARIA) ARIA-H generally occurs in association with an occurrence of ARIA-E. ARIA has been observed very commonly in donanemab clinical studies. ARIA usually occurs early in treatment and is usually asymptomatic.
When present, reported symptoms associated with ARIA may include headache, confusion, nausea, vomiting, unsteadiness, dizziness, tremor, visual disturbances, speech disturbances, worsening cognitive function, alteration of consciousness, and seizures.
8). 8). 8). ARIA can be detected by MRI and while ARIA-E typically resolves on imaging, ARIA-H may persist and stabilise. Most ARIA events were first observed within 24 weeks of initiation of treatment. Most serious ARIA events occurred within 12 weeks of initiation of treatment.
Access to MRI should be available during the treatment period of donanemab. Given preexisting risk factors, patients who are eligible for amyloid treatment therapies are also at risk for spontaneous ARIA. ARIA should be considered as a possible aetiology for neurological symptoms.
8). 2). Enhanced clinical vigilance for ARIA is recommended during the first 24 weeks of treatment with donanemab. 4 “Amyloid-related imaging abnormalities - ARIA”). 6 Recommendations for dosing interruptions and treatment discontinuations in patients with ARIA If symptoms of ARIA-H occur, it is often in the presence of ARIA-E and managed as for ARIA-E.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised February 26, 2026[3]
1. 4). - Patients with bleeding disorders that are not under adequate control. 4). 4). - Patients with poorly controlled hypertension. - Conditions that do not allow MRI assessment, including claustrophobia or the presence of metal (ferromagnetic) implants/cardiac pacemaker.
5
This is not medical advice. Consult a qualified healthcare professional.
Study 1 and Study 2 Overview [see Clinical Studies ( 14 )] In Study 1, safety was assessed in patients who received KISUNLA Dosing Regimen 1 (n = 853) compared to those who received placebo (n = 874). In Study 2, the effect of different dosing regimens of KISUNLA on ARIA was assessed, including in patients who received KISUNLA Dosing Regimen 2 (n=212), which is the recommended dosage and described below.
Incidence of ARIA A lower incidence of ARIA was observed with Dosing Regimen 2 as compared to Dosing Regimen 1. Therefore, Dosing Regimen 2 is the recommended dosage for KISUNLA. 1 )] . Clinical symptoms associated with ARIA-E resolved in approximately 85% of those patients.
Including asymptomatic radiographic events, ARIA, ARIA-E, and ARIA-H were observed in 36%, 24%, and 31% of patients treated with KISUNLA, respectively, compared to 14%, 2%, and 13% of patients on placebo, respectively. , ARIA-H in patients who did not also experience ARIA-E) for KISUNLA compared to placebo.
1 )] . Clinical symptoms associated with ARIA-E resolved in approximately 67% of patients at 12 months. Including asymptomatic radiographic events, ARIA, ARIA-E, and ARIA-H were observed in 29%, 16%, and 25% of patients treated with KISUNLA.
2% of patients on placebo in Study 1, and in 1% of patients treated with KISUNLA in Study 2. Fatal events of intracerebral hemorrhage in patients taking KISUNLA have been observed. Risk Factors for ARIA and Intracerebral Hemorrhage ApoE ε4 Carrier Status The risk of ARIA, including symptomatic and serious ARIA, is increased in apolipoprotein E ε4 (ApoE ε4) homozygotes, which include approximately 15% of Alzheimer's disease patients.
In Study 1, of patients in the KISUNLA arm (n=850), 17% were ApoE ε4 homozygotes, 53% were heterozygotes, and 30% were noncarriers. The incidence of ARIA through 18 months was higher in ApoE ε4 homozygotes (55% on KISUNLA vs. 22% on placebo) than in heterozygotes (36% on KISUNLA vs.
13% on placebo) and noncarriers (25% on KISUNLA vs. 12% on placebo). Among patients treated with KISUNLA, symptomatic ARIA-E occurred in 8% of ApoE ε4 homozygotes compared with 7% of heterozygotes and 4% of noncarriers. Serious events of ARIA occurred in 3% of ApoE ε4 homozygotes, 2% of heterozygotes, and 1% of noncarriers.
In Study 2, of patients treated with KISUNLA Dosing Regimen 2 (n=211), 10% were ApoE ε4 homozygotes, 55% were heterozygotes, and 36% were noncarriers. Symptomatic ARIA-E occurred in 0% of ApoE ε4 homozygotes compared with 4% of heterozygotes and 3% of noncarriers.
The small number of events and limited exposure in the ApoE ε4 subgroups limit definitive conclusions about the risk of ARIA-E. 3 )] . Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with KISUNLA; however, it cannot be determined if they are ApoE ε4 homozygotes and at a higher risk for ARIA.
An FDA-authorized test for detection of ApoE ε4 alleles to identify patients at risk of ARIA if treated with KISUNLA is not currently available. Currently available tests used to identify ApoE ε4 alleles may vary in accuracy and design.
Radiographic Findings of Cerebral Amyloid Angiopathy (CAA) Neuroimaging findings that may indicate CAA include evidence of prior intracerebral hemorrhage, cerebral microhemorrhage, and cortical superficial siderosis. CAA has an increased risk for intracerebral hemorrhage.
The presence of an ApoE ε4 allele is also associated with cerebral amyloid angiopathy. In Study 1, the baseline presence of at least 2 microhemorrhages or the presence of at least 1 area of superficial siderosis on MRI, which may be suggestive of CAA, were identified as risk factors for ARIA.
Patients were excluded from enrollment in Study 1 for findings on neuroimaging of prior intracerebral hemorrhage greater than 1 cm in diameter, more than 4 microhemorrhages, more than 1 area of superficial siderosis, severe white matter disease, and vasogenic edema.
Concomitant Antithrombotic or Thrombolytic Medication In Study 1, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed. The majority of exposures to antithrombotic medications were to aspirin.
The incidence of ARIA-H was 30% (106/349) in patients taking KISUNLA with a concomitant antithrombotic medication within 30 days compared to 29% (148/504) who did not receive an antithrombotic within 30 days of an ARIA-H event. 4% (2/504) in those who did not receive an antithrombotic.
The number of events and the limited exposure to non-aspirin antithrombotic medications limit definitive conclusions about the risk of ARIA or intracerebral hemorrhage in patients taking antithrombotic medications. One fatal intracerebral hemorrhage occurred in a patient taking KISUNLA in the setting of focal neurologic symptoms of ARIA and the use of a thrombolytic agent in Study 1, and one fatal intracerebral hemorrhage occurred in the setting of ARIA and the use of a thrombolytic agent in Study 2.
, tissue plasminogen activator) to a patient already being treated with KISUNLA. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with KISUNLA.
Caution should be exercised when considering the use of KISUNLA in patients with factors that indicate an increased risk for intracerebral hemorrhage and in particular for patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of cerebral amyloid angiopathy.
Radiographic Severity The radiographic severity of ARIA associated with KISUNLA was classified by the criteria shown in Table 5 .
Table 5:
ARIA MRI Classification Criteria a Includes new or worsening superficial siderosis. ARIA Type Radiographic Severity Mild Moderate Severe ARIA-E FLAIR hyperintensity confined to sulcus and/or cortex/subcortex white matter in one location <5 cm.
FLAIR hyperintensity 5 to 10 cm in single greatest dimension, or more than 1 site of involvement, each measuring <10 cm. FLAIR hyperintensity >10 cm with associated gyral swelling and sulcal effacement. One or more separate/independent sites of involvement may be noted.
ARIA-H microhemorrhage Less than or equal to 4 new incident microhemorrhages 5 to 9 new incident microhemorrhages 10 or more new incident microhemorrhages ARIA-H superficial siderosis 1 new a focal area of superficial siderosis 2 new focal areas of superficial siderosis Greater than 2 new focal areas of superficial siderosis In Study 1, the majority of ARIA-E radiographic events occurred early in treatment (within the first 24 weeks), although ARIA can occur at any time and patients can have more than one episode.
Resolution on MRI after the first ARIA-E event occurred in 63% of patients treated with KISUNLA by 12 weeks, 80% by 20 weeks, and 83% overall after detection. 4%, respectively. Among patients treated with KISUNLA, the rate of severe radiographic ARIA-H was highest in ApoE ε4 homozygotes (n=143) compared to heterozygotes (n=452) or noncarriers (n=255) at rates of 22%, 8%, and 4%, respectively.
Table 6 shows the maximum radiographic severity for ARIA-E, ARIA-H microhemorrhage, and ARIA-H superficial siderosis in Study 1 and Study 2. 3 )] . 3 )] . Use clinical judgment in considering whether to continue dosing in patients with recurrent ARIA-E.
3 )] . Enhanced clinical vigilance for ARIA is recommended during the first 24 weeks of treatment with KISUNLA. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI if indicated.
If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment. There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E.
There are limited data for dosing patients who have experienced recurrent episodes of ARIA-E. , registries) to help further the understanding of Alzheimer's disease and the impact of Alzheimer's disease treatments. Providers and patients can contact 1-800-LillyRx (1-800-545-5979) for a list of currently enrolling programs.
1 )]. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction and initiate appropriate therapy. KISUNLA is contraindicated in patients with a history of serious hypersensitivity to donanemab-azbt or to any of the excipients of KISUNLA.
5% of patients on placebo. Infusion-related reactions were mostly mild (57%) or moderate (39%) in severity. Infusion-related reactions resulted in discontinuations in 4% of patients treated with KISUNLA. In Study 2, infusion-related reactions associated with KISUNLA occurred in 16% of patients; the majority (88%) occurred within the first 4 infusions.
Infusion-related reactions were mostly mild (47%) or moderate (50%) in severity. 8% of patients treated with KISUNLA. Most infusion-related reactions associated with KISUNLA occurred during the infusion or within 30 minutes after completion of the infusion, however some have occurred hours after an infusion.
Signs and symptoms of infusion-related reactions include chills, erythema, nausea/vomiting, flushing, difficulty breathing/dyspnea, sweating, elevated blood pressure, headache, chest pain, and low blood pressure. In the event of an infusion-related reaction, the infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated.
Consider pre-treatment with antihistamines, acetaminophen, or corticosteroids prior to subsequent dosing.
Each vial is for single use only. It should be administered over at least 30 minutes. Patients should be observed post- infusion for a minimum of 30 minutes. 6. The vial should be inspected visually for particulate matter and discolouration prior to administration.
Do not use donanemab if it is cloudy or there are visible particles. Missed dose If an infusion is missed, the missed dose should be administered at the next possible occasion. Then, resume the recommended dosing regimen every 4 weeks.
Special populations Paediatric population There is no relevant use of Kisunla in the paediatric population for the treatment of Alzheimer’s disease. 2). 2). The effect of severe hepatic and severe renal impairment on the exposure of donanemab has not been studied.
4). 1. Imaging findings suggestive of Cerebral Amyloid Angiopathy (CAA) that increase the risk of ARIA or intracerebral haemorrhage: - Acute or subacute cerebral haemorrhage - Superficial siderosis - More than 4 microhaemorrhages (defined as ≤ 1 cm in diameter on the T2* sequence) - Severe white matter disease - Pre-treatment MRI showing ARIA-E - Previous cerebral haemorrhage (defined as > 1 cm diameter in the T2* sequence) or previous subarachnoid haemorrhage unless it is no longer at risk of re- bleeding.
- Any finding that could prevent a satisfactory MRI evaluation for safety monitoring. 4). 4 Special warnings and precautions for use Controlled access programme In order to promote the safe and effective use of donanemab, initiation of treatment in all patients should be through a central registration system implemented as part of a controlled access programme.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8. Undesirable Effects). These reactions may be severe or life-threatening and typically occur during infusion or […]
2). Donanemab should be permanently discontinued if serious ARIA-E, serious ARIA-H, intracerebral haemorrhage greater than 1 cm, or recurrent symptomatic or radiographically moderate or severe ARIA events occur. Radiographic severity The radiographic severity of ARIA associated with donanemab was classified by the criteria shown in Table 2.
Table 2:
ARIA MRI Classification criteria ARIA Type Radiographic Severity Mild Moderate Severe ARIA-E FLAIR hyperintensity confined to sulcus and/or cortex/subcortex white matter in one location < 5 cm. FLAIR hyperintensity 5 to 10 cm in single greatest dimension, or more than 1 site of involvement, each measuring < 10 cm.
FLAIR hyperintensity > 10 cm with associated gyral swelling and sulcal effacement. One or more separate/independent sites of involvement may be noted. ARIA-H microhaemorrhage ≤ 4 new incident microhaemorrhages 5 - 9 new incident microhaemorrhages ≥ 10 new incident microhaemorrhages ARIA-H superficial siderosis 1 new or increased focal area of superficial siderosis 2 new or increased focal areas of superficial siderosis > 2 new or increased focal areas of superficial siderosis Abbreviations: FLAIR = fluid-attenuated inversion recovery; ARIA-E = amyloid-related imaging abnormalities- oedema/effusions; ARIA-H = amyloid-related imaging abnormalities haemorrhage/hemosiderin deposition ApoE ε4 carrier status and risk of ARIA ApoE ε4 carriers have a higher frequency (homozygotes greater than heterozygotes) of ARIA-E and ARIA-H, including serious and symptomatic ARIA, compared to non-carriers.
1). 2). Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes. Increased intracerebral haemorrhage risk Caution should be exercised when considering the use of donanemab in patients with factors that indicate an increased risk for intracerebral haemorrhage.
8). Concomitant antithrombotic treatment Baseline use of antithrombotic medicinal products (aspirin, other antiplatelets, or anticoagulants) was allowed in clinical trials with donanemab. The majority of exposures to antithrombotic medicines were to acetylsalicylic acid.
Patients who received donanemab and an antithrombotic medicine (acetylsalicylic acid, other […]