Indication and Important Safety Information

INDICATION

  • ADUHELM is indicated for the treatment of Alzheimer’s disease. ADUHELM should be started in patients with mild cognitive impairment or mild dementia stage of disease, the population studied in clinical trials. ADUHELM is approved under accelerated approval based on reduction in amyloid plaques as seen in patients treated with ADUHELM. Continued approval of ADUHELM may require verification of clinical benefit in a confirmatory study

IMPORTANT SAFETY INFORMATION

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, nausea, confusion, difficulty walking, dizziness, seizures, and vision changes
  • 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.

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.

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.

Please see full Prescribing Information, including Boxed Warning, and Medication Guide.

Prescribing Information Medication Guide
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