ADUHELM- aducanumab injection, solution 
Biogen Inc.

----------

This Medication Guide has been approved by the U.S. Food and Drug Administration

Revised: 08/2023

MEDICATION GUIDE
ADUHELM® (AD-yew-helm)
(aducanumab-avwa)
injection, for intravenous use

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, and infrequently, larger areas of bleeding in the brain can occur. Most people with this type of swelling in the brain do not get symptoms, however some people may have symptoms, such as:
  • headache
  • confusion
  • dizziness
  • vision changes
  • nausea
  • difficulty walking
  • seizures
Some people have a genetic risk factor (homozygous apolipoprotein E gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor.

Some medicines may increase the risk for larger areas of bleeding in the brain in patients taking ADUHELM. Talk to your healthcare provider to see if you are on any medicines that increase this risk.

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 is ADUHELM?
ADUHELM is a prescription medicine used to treat people with Alzheimer's disease.
It is not known if ADUHELM is safe and effective in children.
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.
Especially tell your healthcare provider if you take medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). Ask your healthcare provider for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacists when you get a new medicine.
How will I receive 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
These are not all the possible side effects of ADUHELM. For more information, ask your healthcare provider or pharmacist.
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.
There is a registry that collects information on treatments for Alzheimer's disease. The registry is named ALZ-NET (Alzheimer's Network for Treatment and Diagnostics). Your healthcare provider can help you become enrolled in this registry.
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
Manufactured by: Biogen Inc., Cambridge, MA 02142, U.S. License #1697
ADUHELM is a registered trademark of Biogen. ©2023 Biogen
Revised: 8/2023
Document Id: bdbcb712-6e43-45e4-9404-452239d0daa0
Set id: 41706573-546f-6774-6872-5374726f6e67
Version: 8
Effective Time: 20230831
Biogen Inc.