MEDICATION GUIDE
LEQEMBI® (leh-kem’-bee)
(lecanemab-irmb)
injection, for intravenous or subcutaneous use |
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 can be fatal. 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 who develop ARIA do not get symptoms; however, some people may have symptoms, such as:
|
| ○ headache | ○ vision changes | ○ seizures |
| ○ confusion | ○ nausea | ○ difficulty speaking |
| ○ dizziness | ○ difficulty walking | ○ muscle weakness |
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.
You may be at a higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving LEQEMBI.
Your healthcare provider will do magnetic resonance imaging (MRI) scans before and during your treatment with LEQEMBI to check you for ARIA.
You should carry information that you are receiving LEQEMBI which can cause ARIA and that ARIA symptoms can look like stroke symptoms.
Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.
There are registries that collect information on treatments for Alzheimer’s disease. Your healthcare provider can help you become enrolled in these registries. For more information, call Eisai at 888-274-2378. |
What is LEQEMBI?
LEQEMBI is a prescription medicine used to treat people with Alzheimer’s disease.
It is not known if LEQEMBI is safe and effective in children. |
Do not receive LEQEMBI if you:
- have serious allergic reactions to lecanemab-irmb or to any of the ingredients. See the end of this Medication Guide for a complete list of ingredients in LEQEMBI or LEQEMBI IQLIK.
|
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. |
How will I receive LEQEMBI?
When given in a vein (intravenously)
- LEQEMBI is given by a healthcare provider through a needle placed in your vein (intravenous (IV) infusion) in your arm.
- Your healthcare provider will tell you how often you should receive LEQEMBI. Each infusion will last about 1 hour.
- If you miss an infusion of LEQEMBI, you should receive your next dose as soon as possible.
When given under the skin (subcutaneously)
Read the detailed Instructions for Use that comes with your LEQEMBI IQLIK for information about the right way to prepare and give your LEQEMBI IQLIK injections at home.
- After at least 2 consecutive doses of LEQEMBI IQLIK are given under the direct guidance of your healthcare provider, they will decide if it is appropriate for you or a caregiver to give (administer) LEQEMBI IQLIK.
- Your healthcare provider will show you how to use LEQEMBI IQLIK and tell you how often you should use it. Use LEQEMBI IQLIK exactly as your healthcare provider tells you to.
- LEQEMBI IQLIK is given as an injection under your skin (subcutaneous injection), into the front of your thighs or stomach-area (abdomen) by you or a caregiver. A healthcare provider or a caregiver may also give you an injection of LEQEMBI IQLIK in the back of your upper arm.
- Do not inject into moles, scars, bruises, tattoos, or into areas where the skin is red, hard, tender, or injured.
- Use a different injection site at least 1 inch away from the last site each time you use LEQEMBI IQLIK.
- Do not inject into the 2-inch area around the belly button.
- If you miss a dose of LEQEMBI IQLIK, inject the missed dose as soon as possible up to 6 days after the missed dose. Continue (resume) your next injection on your regularly scheduled day.
|
What are the possible side effects of LEQEMBI?
LEQEMBI can cause serious side effects, including:
-
see “What is the most important information I should know about LEQEMBI?”
-
serious allergic reactions. Swelling of the face, lips, mouth, or tongue, hives, or difficulty breathing have happened during treatment with LEQEMBI. Tell your healthcare provider and get medical help right away if you have any symptoms of a serious allergic reaction during or after treatment with LEQEMBI.
-
infusion-related reactions. Infusion-related reactions are a common side effect with LEQEMBI injection into a vein (intravenously), which can be serious. You will receive your infusion at a healthcare facility. If a serious infusion reaction happens while you are receiving LEQEMBI, your infusion may be stopped. Serious infusion reactions can also occur after completion of the infusion. Tell your healthcare provider right away if you get these symptoms during an infusion or after completion of the LEQEMBI infusion:
|
| ○ fever | ○ dizziness or lightheadedness |
| ○ flu-like symptoms (chills, body aches, feeling shaky, and joint pain) | ○ changes in your heart rate or feel like your chest is pounding |
| ○ nausea | ○ difficulty breathing or shortness of breath |
| ○ vomiting | ○ changes in blood pressure |
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.
-
injection-related reactions. Injection-related reactions may occur with LEQEMBI injection under the skin (subcutaneous injection with LEQEMBI IQLIK). Redness, swelling, heat, pain, itching, rash, bump, bruising and blood collection under the skin at the injection site may be observed. Headache, chills, fatigue, or fever may also be observed after an injection. Tell your healthcare provider if you experience these symptoms during or after an injection.
The most common side effects of LEQEMBI include:
- infusion-related reactions with LEQEMBI injected into a vein
- 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. 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. |
How should I store LEQEMBI IQLIK?
- Store LEQEMBI IQLIK autoinjectors in a refrigerator between 36°F to 46°F (2°C to 8°C).
- Do not freeze.
- Keep LEQEMBI IQLIK autoinjectors in the original carton until ready to use, to protect from light.
- LEQEMBI IQLIK may be stored at room temperature up to 77°F (25°C) for up to 14 days in the original carton. Do not place it back in the refrigerator if it has been brought to room temperature.
- Do not shake LEQEMBI IQLIK.
- Throw away (dispose of) LEQEMBI IQLIK that is out of date, or if it is not stored the right way.
Keep LEQEMBI IQLIK and all medicines out of the reach of children. |
General information about the safe and effective use of LEQEMBI.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LEQEMBI for a condition for which it was not prescribed. Do not give LEQEMBI to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about LEQEMBI that is written for health professionals. |
What are the ingredients in LEQEMBI?
Active ingredient: lecanemab-irmb.
Inactive ingredients (intravenous): arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polysorbate 80, and water for injection.
Inactive ingredients (subcutaneous): arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polysorbate 80, and water for injection. |
Manufactured by:
Eisai Inc.
Nutley, NJ 07110
U.S. License No. 1862
LEQEMBI® is a registered trademark of Eisai R&D Management Co., Ltd.
LEQEMBI IQLIK® is a registered trademark of Eisai R&D Management Co., Ltd.
© 2026 Eisai Inc. and Biogen
For more information, go to www.LEQEMBI.com or call 1-888-274-2378. |