donanemab at a glance
Medicine class
Humanised IgG1 monoclonal antibody targeting amyloid beta plaques
Licensed use
Mild cognitive impairment or mild dementia due to Alzheimer’s disease in ApoE4 non-carriers or heterozygotes
Administration
Intravenous infusion given by a trained healthcare professional, followed by observation
Essential checks
Amyloid confirmation, ApoE4 testing and brain MRI assessment before treatment
Key safety concern
Amyloid-related imaging abnormalities involving brain swelling or bleeding
What is donanemab used for?
The UK licence covers early symptomatic Alzheimer’s disease in a defined adult population.
Mild cognitive impairment due to Alzheimer’s disease.
Mild dementia due to Alzheimer’s disease.
Use requires confirmed amyloid pathology and either no ApoE4 copies or one ApoE4 copy.
How does donanemab work?
Donanemab binds to a modified form of amyloid beta in established brain plaques, promoting their removal by immune cells called microglia. This can slow decline in cognition and everyday functioning but cannot restore function already lost.
donanemab preparations and strengths
Solution for infusion
Route: Intravenous
Strengths: 350 mg
How to take donanemab
A healthcare professional dilutes donanemab and administers it through a vein. Monitoring is needed during and after administration. Attend scheduled MRI scans and immediately report symptoms arising during or after an infusion.
It is not taken by mouth, so food does not affect administration.
The concentrate must be prepared aseptically and must not be shaken.
Keep the patient alert information available and tell other healthcare professionals about donanemab use.
donanemab side effects
Common or expected effects
- MRI-detected brain swelling or small areas of bleeding
- Headache
- Nausea or vomiting
- Infusion reactions such as flushing, chills, sweating, chest tightness, breathlessness or blood-pressure changes
Get urgent medical advice
- Symptomatic brain swelling or bleeding
- Larger intracerebral haemorrhage
- Anaphylaxis or another severe infusion-related hypersensitivity reaction
donanemab in pregnancy
Data in pregnancy are limited, and donanemab is not recommended during pregnancy. Discuss pregnancy, plans for pregnancy or becoming pregnant promptly with the specialist team.
donanemab while breastfeeding
It is unknown how donanemab affects a breastfed infant. Because IgG antibodies can enter human milk, specialist assessment of the potential benefits and risks is required.
donanemab interactions
Formal interaction studies have not been performed. Conventional pharmacokinetic interactions are not expected, but medicines affecting blood clotting are important.
Anticoagulants, including warfarin and direct oral anticoagulants
Treatment must not be started during ongoing anticoagulation because intracerebral bleeding risk is increased. Anticoagulation becoming necessary during therapy requires urgent specialist review.
Thrombolytic medicines
These may increase severe intracranial-bleeding risk and should generally be avoided unless an immediately life-threatening indication leaves no alternative.
Aspirin and other antiplatelet medicines
Concomitant use is permitted in the product information, but bleeding risk and new neurological symptoms require careful assessment.
Common questions about donanemab
Answers are fully visible for fast scanning and source review.
Does donanemab cure Alzheimer’s disease?
No. It can slow clinical decline in eligible people but does not reverse the disease or restore abilities already lost.
Why are ApoE4 testing and MRI scans needed?
ApoE4 status determines eligibility and helps assess ARIA and bleeding risk. MRI identifies existing risks and monitors for ARIA.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.