Reviewed by: HU Medical Review Board | Last reviewed: January 2024 | Last updated: February 2024
Editor's note: Aduhelm™ (aducanumab) is being discontinued in 2024. It is not being discontinued due to safety or efficacy reasons. People who are receiving the drug as part of a clinical trial will have access to it until May 1, 2024. Those who are receiving it by prescription will have it available to them until November 1, 2024. You can see all updates regarding Aduhelm here.
Aduhelm™ (aducanumab) is a first-of-its-kind drug approved for Alzheimer’s disease and the first drug approved for the condition in 18 years. In June 2021, the US Food and Drug Administration granted accelerated approval for Aduhelm as the first therapy that targets the changes in the brain that cause Alzheimer’s.1-3
Nearly 3,500 people with Alzheimer’s were represented in 3 separate studies on Aduhelm. The studies included studies that were randomized, placebo-controlled, and dose-ranging. Those receiving Aduhelm had significant decreases in beta-amyloid plaque, while those who received a placebo had no decrease in plaque. But even with the decrease in beta-amyloid plaques, several studies have given mixed results when it comes to whether this can slow down Alzheimer’s disease progression.1
What are the ingredients in Aduhelm?
The active ingredient in Aduhelm is aducanumab.2
How does Aduhelm work?
In Alzheimer’s disease, plaques in the brain form when protein pieces called beta-amyloid clump together. These clumps of beta-amyloid are sticky and form plaques in the brain. The plaques block nerve signals within the brain, activate the immune system, and trigger brain inflammation. A buildup of these plaques can be associated with the classic symptoms of Alzheimer’s, including problems with:4
- Learning and memory
- Thinking and planning
- Speaking and understanding speech
- Sensing where your body is in relation to objects around you
Aduhelm is a laboratory-made antibody that reduces the beta-amyloid plaques in the brains of those with Alzheimer’s disease.2
What are the possible side effects?
The side effects of Aduhelm may include:2
- Amyloid-related imaging abnormalities (ARIAs)
- Allergic reactions
- Altered mental status
- Immunogenicity (an unwanted immune response)
These are not all the possible side effects of Aduhelm. Talk to your doctor about what to expect when taking Aduhelm. You should also call your doctor if you have any changes that concern you when taking Aduhelm.
Other things to know
ARIAs most often present as temporary swelling in different areas of the brain. The swelling usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain. Most people with swelling do not have symptoms. However, some people may have symptoms such as headache, confusion, dizziness, vision changes, or nausea.2
Aduhelm is given by IV injection (through the vein) over the course of 1 hour. After the second infusion, your doctor might change the dose. Talk to your doctor if you have questions about the dosing of this drug.2
Right now, Medicine and some insurance companies are only covering Aduhelm for people enrolled in clinical or research trials. Other insurance companies are not covering Aduhelm.5
If you miss an infusion of Aduhelm, resume the same dose as soon as possible. Infusions are to be given every 4 weeks and at least 21 days apart.2
It is not known if Aduhelm can harm an unborn baby. If you or your partner can become pregnant, you should use birth control during treatment and for some time after the last dose of Aduhelm. You should also not breastfeed during treatment with Aduhelm and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Aduhelm.2
Before beginning treatment for Alzheimer’s disease, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.
For more information, read the full prescribing information of Aduhelm.