What is Aduhelm?
- Aduhelm is a prescription medicine used to treat people with Alzheimer's disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
It is not known if Aduhelm is safe and effective in children.
What is the most important information I should know about Aduhelm?
Aduhelm can cause serious side effects, including:
Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a common side effect that does not usually cause any symptoms but can be serious. It is most commonly seen as temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain with the swelling. Although most people with swelling in areas of the brain do not have symptoms, some people may have symptoms, such as:
- headache
- dizziness
- nausea
- confusion
- vision changes
Your healthcare provider will do magnetic resonance imaging (MRI) scans before and during your treatment with Aduhelm to check you for ARIA.
Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.
What should I tell my healthcare provider before using Aduhelm?
Before receiving Aduhelm, tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. It is not known if Aduhelm will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with Aduhelm.
- are breastfeeding or plan to breastfeed. It is not known if aducanumab-avwa (the active ingredient in Aduhelm) passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving Aduhelm.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Aduhelm?
Aduhelm is given through a needle placed in your vein (intravenous (IV) infusion) in your arm.
Aduhelm is given every 4 weeks. Each infusion will last about 1 hour.
What are the possible side effects of Aduhelm?
Aduhelm can cause serious side effects, including:
- See above “What is the most important information I should know about Aduhelm?”
- Serious allergic reactions. Swelling of the face, lips, mouth, or tongue and hives have happened during an Aduhelm infusion. Tell your healthcare provider if you have any of the symptoms of a serious allergic reaction during or after Aduhelm infusion.
The most common side effects of Aduhelm include:
- swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA)
- headache
- fall
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Aduhelm
Medicines are sometimes prescribed for purposes other than those listed in this Medication Guide. You can ask your pharmacist or healthcare provider for more information about Aduhelm that is written for health professionals. For more information, go to www.aduhelm.com or call at 1-833-425-9360.
What are the ingredients in Aduhelm?
Active ingredient: aducanumab-avwa
Inactive ingredients: L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, and water for injection
