Aduhelm (Aducanumab) is a monoclonal antibody targeting amyloid-beta, indicated for the treatment of Alzheimer's disease. As the first disease-modifying therapy for Alzheimer's disease to receive accelerated approval from the FDA, its administration methods and precautions are crucial for treatment efficacy.
How to Use Aduhelm (Aducanumab)
Preparation Before Administration
Before initiating Aduhelm treatment, the patient’s brain magnetic resonance imaging (MRI) results from the past year must be obtained.
Meanwhile, it is necessary to confirm that the patient’s white blood cell (WBC) count has decreased to below 25 Gi/L, and complete a baseline electrocardiogram (ECG) and electrolyte level assessment.
These tests are essential for monitoring the risk of potential amyloid-related imaging abnormalities (ARIA).
Administration Regimen and Dose Titration
Aduhelm is administered via intravenous infusion. The standard maintenance dose is 10 mg/kg, given once every 4 weeks, with each infusion lasting approximately 1 hour.
Dose titration is required in the initial stage of treatment:
Infusions 1–2: 1 mg/kg
Infusions 3–4: 3 mg/kg
Infusions 5–6: 6 mg/kg
Infusion 7 and beyond: 10 mg/kg (maintenance dose)
The interval between each infusion must be at least 21 days. If a dose is missed, the same dose should be administered as soon as possible, while maintaining the once-every-4-week administration frequency.
Drug Preparation and Infusion
Aduhelm must be diluted before use.
Calculate the required volume of the drug (concentration: 100 mg/mL) based on the patient’s actual body weight, draw the corresponding volume, and add it to 100 mL of 0.9% sodium chloride injection.
Gently invert to mix; do not shake.
The diluted solution should be used immediately. If storage is necessary, it can be stored at 2–8°C for 3 days or at room temperature (≤30°C) for 12 hours.
An inline filter of 0.2 or 0.22 micrometers must be used during infusion.
Dose Adjustment of Aduhelm (Aducanumab)
Dose Adjustment Based on ARIA
Close monitoring for ARIA (amyloid-related imaging abnormalities) is required during Aduhelm treatment, especially within the first 8 administrations.
ARIA-E (edema type): If symptoms occur, administration should be suspended. Treatment may be cautiously resumed after symptoms resolve and follow-up MRI shows stability.
ARIA-H (hemorrhagic type):
For 10 or more new microhemorrhages or >2 foci of superficial siderosis: Suspend administration; treatment may continue only after clinical evaluation confirms MRI stability.
For ≤9 new microhemorrhages or ≤2 foci of superficial siderosis: Treatment can continue, but enhanced monitoring is required.
During treatment, MRI examinations should be performed before the 7th and 12th infusions. For moderate or severe ARIA, administration may need to be suspended; when resuming, treatment can continue at the original dose.
Dose Adjustment Based on Adverse Reactions
QTc interval prolongation: If QTc ≥ 500 ms or an increase of >60 ms from baseline occurs, suspend administration. After correcting electrolyte disturbances, treatment can continue at the original dose.
Hypersensitivity reactions: If angioedema or urticaria occurs, stop the infusion immediately and administer appropriate treatment.
Precautions for Aduhelm (Aducanumab) Use in Special Populations
Patients with Hepatic Impairment
No dose adjustment is required for patients with mild to moderate hepatic impairment.
Data on patients with severe hepatic impairment are limited, so a careful assessment of the risk-benefit ratio is necessary.
Patients with Renal Impairment
No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance: 30–89 mL/min).
Experience with the use of Aduhelm in patients with severe renal impairment (<30 mL/min) is limited.
Pregnant and Lactating Women
There is insufficient data to evaluate the risk of Aduhelm use during pregnancy. Women of childbearing potential should confirm non-pregnancy within 7 days before treatment, and use effective contraceptive measures during treatment and for 4 months after discontinuing treatment.
The risk of Aduhelm use during lactation is unknown, so a careful weighing of the benefits and risks is required.
