Donanemab
Donanemab is a humanized monoclonal antibody therapy designed to treat Alzheimer's disease by targeting and reducing amyloid beta plaques in the brain. It is specifically indicated for patients with early symptomatic Alzheimer's disease, including those with mild cognitive impairment or mild dementia. By binding to N-truncated pyroglutamate amyloid beta, donanemab helps slow the progression of cognitive decline in appropriate patients.
Donanemab is an amyloid-targeting monoclonal antibody approved for treating early Alzheimer's disease by reducing brain amyloid plaques.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- N06DX05
- RxNorm
- 2687966
- Generic
- Donanemab
- Class
- atc-n06
- Brands
- Kisunla
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks - discuss with healthcare provider
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular prenatal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingavoid
discontinue breastfeeding or avoid use - decision should be made based on benefit-risk assessment
monitor infant for adverse effects
geriatric
elderlyno adjustment required
use as indicated - monitor for ARIA (amyloid-related imaging abnormalities)
periodic MRI monitoring for ARIA, especially during initiation
pediatric_age
children adolescentsnot applicable
not indicated for pediatric patients - Alzheimer's disease does not occur in this population
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mild renal impairmentno initial dose adjustment
monitor renal function - no dose adjustment needed for mild impairment
monitor renal function periodically
Use with caution and monitor for adverse effects.
renal_impairment
moderate severe renal impairmentuse with caution
use with caution - limited data available
close monitoring of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentno initial dose adjustment
monitor liver function - no dose adjustment needed for mild impairment
periodic liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate severe hepatic impairmentuse with caution
use with caution - not studied in severe hepatic impairment
close monitoring of liver function
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Classification based on mechanism of action
FDA approval date
FDA approval for treatment of early Alzheimer's disease
Indication
Approved therapeutic indication
Mechanism of action
Pharmacological mechanism
Donanemab is indicated for the treatment of early symptomatic Alzheimer's disease, including patients with mild cognitive impairment (MCI) due to Alzheimer's disease and those with mild dementia due to Alzheimer's disease with confirmed amyloid pathology.
Donanemab is a humanized IgG1 monoclonal antibody that specifically binds to insoluble N-truncated pyroglutamate amyloid beta, a component of amyloid plaques. By binding to these plaques, it facilitates their clearance through immune-mediated mechanisms, addressing a core pathophysiological feature of Alzheimer's disease.
Common side effects include amyloid-related imaging abnormalities (ARIA), which can be serious. Treatment requires amyloid PET scan confirmation of plaque burden prior to initiation. Regular MRI monitoring is recommended during therapy. Patients should be assessed for completion of treatment course once sustained amyloid clearance is achieved.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy