Aduhelm (Aducanumab) is the first biological product targeting the pathological mechanism of Alzheimer's disease (AD) to receive accelerated approval from the U.S. FDA in 2021. It exerts its effect by reducing beta-amyloid (Aβ) plaques.

Indications for Aduhelm (Aducanumab)

Scope of Application

Applicable to patients with mild cognitive impairment (MCI) or mild dementia (corresponding to clinical stages 3-4 of Alzheimer's disease).

The presence of beta-amyloid plaques must be confirmed by brain imaging or cerebrospinal fluid (CSF) testing.

Basis for Approval: Based on the observed effect of beta-amyloid plaque reduction in clinical trials; its continued approval is contingent on the confirmation of clinical benefits in subsequent confirmatory trials.

Special Note: Not applicable to patients with advanced Alzheimer's disease or other types of dementia.

Specifications and Properties of Aduhelm (Aducanumab)

Specification: 170mg/1.7mL

Appearance: Clear to opalescent, colorless to yellow solution, with a red flip-top cap.

Concentration: 100mg/mL, containing excipients such as L-arginine hydrochloride and polysorbate 80; pH is approximately 5.5.

Specification: 300mg/3mL

Appearance: Clear to opalescent, colorless to yellow solution, with a blue flip-top cap.

Concentration: 100mg/mL; the excipient composition is consistent with the 170mg specification.

Property Verification

Before use, check whether the solution is clear and free of particles. If turbidity, discoloration, or foreign matter is present, use is prohibited.

Storage Methods for Aduhelm (Aducanumab)

Unopened Vials

Store in the original packaging in a refrigerator at 2°C-8°C, protected from light. Freezing or shaking is prohibited.

If temporary removal from refrigeration is necessary, it can be stored at below 25°C, protected from light, for a maximum of 3 days. The total cumulative time out of refrigeration shall not exceed 24 hours.

Diluted Solution

Must be diluted with 100mL of 0.9% sodium chloride injection; mix gently by inverting (shaking is prohibited).

It is recommended to use the diluted solution immediately. Alternatively, it can be stored in a refrigerator at 2°C-8°C for 3 days, or at room temperature (≤30°C) for no more than 12 hours.

Disposal: Unused medicinal solution or expired drugs must be disposed of through professional medical waste channels.