Aduhelm (aducanumab) is a monoclonal antibody targeting beta-amyloid, acceleratedly approved by 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 follow standardized medication management procedures.
Precautions for Aduhelm (Aducanumab) Administration
Confirmation of Indications
Aduhelm is indicated for patients with Alzheimer's disease who have confirmed 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; the final clinical benefits still need to be confirmed by confirmatory trials.
Baseline Examination Requirements
Neuroimaging Examination: A brain MRI must be completed within 1 year before treatment to rule out cerebral microbleeds (>10) or focal superficial hemosiderosis (>2 sites).
Laboratory Examinations: Including complete blood count and electrolyte (potassium/magnesium) levels.
Cognitive Function Assessment: Standardized scales such as the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and Mini-Mental State Examination (MMSE).
ApoE ε4 Genotype Testing: Carriers of the ApoE ε4 allele have an increased risk of developing Amyloid-Related Imaging Abnormalities (ARIA).
Medication Use in Special Populations
Pregnant Women: No human data are available. Animal studies have not shown direct developmental toxicity, but the benefits and risks should be carefully weighed before use.
Lactating Women: Whether the drug is excreted into human milk is unknown; it is recommended to discontinue breastfeeding during treatment.
Patients with Hepatic or Renal Impairment: No dosage adjustment is required, but systematic research data on its use in these populations are lacking.
Monitoring for Aduhelm (Aducanumab) Therapy
Monitoring for Amyloid-Related Imaging Abnormalities (ARIA)
Monitoring Protocol: Baseline brain MRI (within 1 year before treatment).
MRI must be rechecked before the 7th infusion (before the first 10 mg/kg dose) and the 12th infusion.
An immediate MRI should be performed if neurological symptoms occur.
Enhanced monitoring is required for ApoE ε4 carriers.
Electrocardiogram (ECG) Monitoring
Baseline ECG before treatment (QTcF < 450 ms).
First 4 weeks of treatment: ECG once a week.
After 4 weeks: ECG once a month.
The frequency of monitoring should be increased when co-administered with drugs that prolong the QT interval.
Clinical Symptom Monitoring
Common Symptoms: Headache (13%), confusion (5%), dizziness (4%).
Severe Symptoms: Visual disturbances, seizures, etc. (incidence: 0.3%).
Differentiation Syndrome: Fever, dyspnea, rapid weight gain, etc.
If the above symptoms occur, immediate evaluation is required, and administration should be suspended if necessary.
