IMPORTANT SAFETY INFORMATION

What is the most important information I should know about LEQEMBI?

LEQEMBI can cause serious side effects including:

• Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA 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

Your healthcare provider will do magnetic resonance imaging (MRI) scans before and during your treatment with LEQEMBI to check you for ARIA. 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.

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 LEQEMBI, 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 LEQEMBI will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with LEQEMBI.

• are breastfeeding or plan to breastfeed. It is not known if lecanemab-irmb (the active ingredient in LEQEMBI) passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving LEQEMBI.

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 pharmacist when you get a new medicine.

What are the possible side effects of LEQEMBI?

LEQEMBI can cause serious side effects, including:

• See above "What is the most important information I should know about LEQEMBI?"

• Infusion-related reactions. Infusion-related reactions are a common side effect which can be serious. Tell your healthcare provider right away if you get these symptoms during an infusion of LEQEMBI:

  – fever

  – flu-like symptoms (chills, body aches, feeling shaky and joint pain)

  – nausea

  – vomiting

  – dizziness or lightheadedness

  – changes in your heart rate or feel like your chest is pounding

  – difficulty breathing or shortness of breath

If you have an infusion-related reaction, your healthcare provider may give you medicines before your LEQEMBI infusions to decrease your chance of having an infusion-related reaction. These medicines may include antihistamines, anti-inflammatory medicines, or steroids.

The most common side effects of LEQEMBI include: infusion-related reactions, headache and swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA).

These are not all the possible side effects of LEQEMBI. Call your doctor for more information and medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the full Prescribing Information and Medication Guide for LEQEMBI.