What is LEQEMBI?

LEQEMBI is a prescription medicine used to treat people with Alzheimer’s disease.

If you have serious allergic reactions to any of the ingredients in LEQEMBI, you should not be treated with LEQEMBI.

Important Safety Information

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

LEQEMBI can cause serious side effects, including:

• ARIA (amyloid-related imaging abnormalities). There are usually no signs of ARIA. In rare cases, it can lead to serious complications
• ARIA can show up as swelling in parts of the brain or small spots of bleeding
• Larger areas of bleeding in the brain may occur, but this is uncommon
• ARIA usually goes away over time
• Most people with ARIA don’t have any symptoms. However, some people may notice:
  • headache
  • confusion that gets worse
  • dizziness
  • vision problems
  • nausea
  • problems walking
  • seizures
• Some people have a gene called ApoE4 that may increase the risk of ARIA. Talk to your healthcare provider about testing to see if you have this gene
• Some medicines can increase the risk of larger areas of bleeding in the brain for people taking LEQEMBI. Talk to your healthcare provider to see if any of the medicines you’re taking increase this risk
• Your healthcare provider will check for ARIA with MRI (magnetic resonance imaging) scans before you start LEQEMBI and during treatment

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 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 any of the ingredients in LEQEMBI pass 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 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 (including aspirin). Ask your healthcare provider for a list of these medicines if you are not sure.

Keep a list of the medicines you take. Show it to 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:

• ARIA (amyloid-related imaging abnormalities) (see above)
• Serious allergic reactions may happen during a LEQEMBI infusion. Tell your healthcare provider if you notice any of these symptoms during or after a LEQEMBI infusion:
  • swelling of the face, lips, mouth, or tongue
  • itchy bumps on the skin, also known as hives
  • difficulty breathing
• Infusion-related reactions are common and can sometimes be serious. Tell your healthcare provider right away if you notice any of these symptoms during an infusion:
  • fever
  • flu-like symptoms (chills, joint and body aches, feeling shaky)
  • nausea and/or vomiting
  • dizziness or lightheadedness
  • fast or slow heart rate, or feeling like your chest is pounding
  • difficulty breathing or shortness of breath

Your healthcare provider may give you medicines before your next infusion to lower the chance of having a reaction.

The most common side effects of LEQEMBI include:

• infusion-related reactions
• swelling in areas of the brain, with or without small spots of bleeding in or on the surface of the brain (ARIA)
• headache

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 including Boxed WARNING, and Medication Guide for LEQEMBI.

© 2024 Eisai Inc. and Biogen.

LEQE-US3092 January 2024

All trademarks are the property of their respective owners.

LEQEMBI® is a registered trademark of Eisai R&D Management Co., Ltd.