Aduhelm (Aducanumab) is a beta-amyloid monoclonal antibody that received accelerated approval from the U.S. FDA in 2021 for the treatment of Alzheimer's disease. As the first biological agent targeting the underlying pathological mechanism of Alzheimer's disease, its clinical application must strictly adhere to standardized medication management procedures.

Precautions for the Use of Aduhelm (Aducanumab)

Confirmation of Indications

Aduhelm is indicated for patients with Alzheimer's disease who have been confirmed to have beta-amyloid pathology through brain amyloid PET imaging or cerebrospinal fluid testing.

This indication was granted accelerated approval based on the surrogate endpoint of reduced beta-amyloid plaques, and the final clinical benefits still need to be confirmed by confirmatory trials.

Requirements for Baseline Examinations

Neuroimaging Examination: A brain MRI must be completed within 1 year before treatment to rule out cerebral microbleeds (>10) or focal superficial hemosiderin deposits (>2 sites).

Laboratory Examinations: These include a complete blood count and measurements of electrolyte (potassium/magnesium) levels.

Cognitive Function Assessment: Standardized scales such as the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and the Mini-Mental State Examination (MMSE) should be used.

ApoEε4 Genotype Testing: Carriers of the ApoEε4 allele have an increased risk of developing Amyloid-Related Imaging Abnormalities (ARIA).

Medication Use in Special Populations

Pregnant Women: There is no data available from human studies. Animal studies have not shown direct developmental toxicity, but the risks and benefits should be carefully weighed.

Lactating Women: It is unknown whether the drug passes into breast milk. It is recommended to discontinue breastfeeding during treatment.

Patients with Hepatic or Renal Impairment: No dosage adjustment is required, but there is a lack of systematic research data.

Medication Monitoring for Aduhelm (Aducanumab)

Monitoring for Amyloid-Related Imaging Abnormalities (ARIA)

Monitoring Protocol: A baseline brain MRI (within 1 year before treatment) is required.

An MRI re-examination must be performed before the 7th infusion (prior to the first 10mg/kg dose) and the 12th infusion.

An MRI should be conducted immediately if neurological symptoms occur.

Enhanced monitoring is necessary for ApoEε4 carriers.

Electrocardiogram (ECG) Monitoring

Baseline ECG before Treatment: The corrected QT interval using Fridericia's formula (QTcF) should be <450ms.

First 4 Weeks of Treatment: An ECG should be performed once a week.

After 4 Weeks: An ECG should be performed once a month.

The frequency of monitoring should be increased when the drug is used in combination with medications that prolong the QT interval.

Monitoring of Clinical Symptoms

Common Symptoms: Headache (13%), confusion (5%), and dizziness (4%).

Severe Symptoms: Visual disturbances, seizures, etc. (incidence rate: 0.3%).

Differentiation Syndrome: Symptoms include fever, dyspnea, rapid weight gain, etc.

If the above symptoms occur, immediate evaluation is required, and administration of the drug should be suspended if necessary.