Aduhelm (aducanumab) is a monoclonal antibody targeting amyloid beta, used 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 obtained within the past year must be acquired.
At the same time, it is necessary to confirm that the patient’s white blood cell (WBC) count has decreased to below 25 Gi/L, and complete baseline electrocardiogram (ECG) examination and electrolyte level assessment.
These examinations are of great importance 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 subsequent infusions: 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 needs to 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 microns must be used during infusion.
Dose Adjustment of Aduhelm (Aducanumab)
Dose Adjustment Based on ARIA
During Aduhelm treatment, close monitoring for ARIA (Amyloid-Related Imaging Abnormalities) is required, especially within the first 8 administrations. Graded management should be conducted based on MRI results:
ARIA-E (Edema Type): If symptoms occur, administration should be suspended. After symptoms resolve and follow-up MRI shows stability, treatment can be resumed cautiously.
ARIA-H (Hemorrhagic Type):
For ≥10 new microbleeds or >2 foci of focal superficial siderosis: Suspend administration; treatment can be continued only if MRI shows stability after clinical evaluation.
For ≤9 new microbleeds or ≤2 foci of focal superficial siderosis: Treatment can be continued, 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, and when resuming, treatment can continue at the original dose.
Dose Adjustment Based on Adverse Reactions
QTc Interval Prolongation: If QTc ≥ 500 ms or increases by >60 ms compared to baseline, suspend administration. After correcting electrolyte disorders, treatment can be continued at the original dose.
Hypersensitivity Reactions: If angioedema or urticaria occurs, stop the infusion immediately and administer appropriate treatment.
Dose Adjustment Based on Drug Interactions
When used concomitantly with strong CYP3A4 inhibitors, the dose should be adjusted:
For patients ≥40 kg: Reduce from 270 mg to 160 mg, twice daily.
For patients <40 kg: Reduce from 160 mg/m² to 95 mg/m², twice daily.
The original dose can be resumed 5 half-lives after discontinuing the strong CYP3A4 inhibitor. Concomitant use with strong or moderate CYP3A4 inducers should be avoided.
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, and the risk-benefit ratio should be carefully evaluated.
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 assess the risk of Aduhelm use during pregnancy. Women of childbearing potential should confirm they are not pregnant within 7 days before treatment, and use effective contraceptive measures during treatment and for 4 months after discontinuing treatment.
The risk of using Aduhelm during lactation is unknown, and the benefits and risks should be weighed.
