Aduhelm (Aducanumab) is the first monoclonal antibody drug targeting beta-amyloid plaques in Alzheimer's disease to receive accelerated approval from the U.S. FDA. It is indicated for patients with early-stage Alzheimer's disease.
What Are the Side Effects of Aduhelm (Aducanumab)?
Amyloid-Related Imaging Abnormalities (ARIA)
ARIA Edema (ARIA-E): Occurs in 35% of patients, manifesting as brain edema or cerebrospinal fluid in the cerebral sulci.
ARIA Microhemorrhage (ARIA-H): Occurs in 19% of patients, including cerebral microhemorrhages and superficial siderosis.
Neurological Symptoms
Headache (21%)
Dizziness (4%)
Other Reactions
Falls (15%)
Diarrhea (9%)
Confusion/Delirium (8%)
Severe Side Effects of Aduhelm (Aducanumab) That Require Vigilance
Amyloid-Related Imaging Abnormalities (ARIA)
High-Risk Population: Carriers of the ApoEε4 gene (incidence rate: 42% vs. 20% in non-carriers).
Severe Manifestations:
Cerebral edema: 13% of cases are severe, accompanied by headache, confusion, and visual impairment.
Cerebral microhemorrhages: Intervention is required if there are 10 or more new hemorrhages.
Management Principles:
For symptomatic ARIA, administration must be suspended and an MRI evaluation conducted.
For asymptomatic ARIA-E or mild-to-moderate ARIA-H, medication can be continued but close monitoring is necessary.
Hypersensitivity Reactions
Clinical Manifestations: Angioedema, urticaria (occurring during infusion).
Emergency Measures: Immediately stop the infusion and administer antihistamines/glucocorticoids.
Other High-Risk Events
Fall Risk: Enhanced care is required for elderly patients.
QT Interval Prolongation: Baseline and regular electrocardiogram (ECG) monitoring is necessary.
Precautions for Aduhelm (Aducanumab) Administration
Administration Specifications
Initial Titration:
1 mg/kg for the 1st - 2nd doses;
3 mg/kg for the 3rd - 4th doses;
6 mg/kg for the 5th - 6th doses;
10 mg/kg starting from the 7th dose.
Maintenance Dose: 10 mg/kg administered intravenously once every 4 weeks.
Infusion Requirements
Dilute with 0.9% sodium chloride to a volume of 100 mL and use a 0.2/0.22 μm filter.
Infusion time should be ≥ 1 hour; the infusion must be terminated immediately if an allergic reaction occurs.
Imaging Monitoring
Mandatory Checkpoints:
Baseline brain MRI within 1 year before medication initiation;
MRI before the 7th (first 10 mg/kg dose) and 12th infusions.
Abnormality Management: Clinical evaluation is required if there are ≥ 10 new microhemorrhages or > 2 cases of superficial siderosis.
Special Population Management
Pregnancy: Contraindicated; a negative pregnancy test must be confirmed before medication administration.
Elderly Patients: Patients aged 75 years and above account for 32% of the total, requiring individualized assessment.
Patient Education Key Points
Symptom Recognition: Seek medical attention immediately if symptoms such as headache, confusion, or rash occur.
Living Recommendations: Avoid strenuous exercise to prevent falls.
