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.