Leqembi (lecanemab-irmb) is used for Alzheimer’s disease to slow disease progression in patients who are at the stage of mild cognitive impairment or mild dementia, and also have a buildup of amyloid beta plaques in their brain. Leqembi works by reducing amyloid beta plaques in the brain and so slows the progression of Alzheimer’s disease. Leqembi helps control Alzheimer’s disease but does not cure it.

Leqembi (lecanemab-irmb) is from a class of medications called monoclonal antibodies.

Alzheimer’s disease is a type of dementia that affects memory, thinking, and behavior, which can eventually grow severe enough to interfere with daily tasks. One of the causes of Alzheimer’s disease is thought to be plaques of beta-amyloid that accumulate in the brain and damage nerve cells which results in the symptoms of Alzheimer’s. Leqembi reduces amyloid beta plaques, and so slows the decline of Alzheimer’s Disease.

Leqembi was originally FDA-approved on January 6, 2023, under the Accelerated Approval Pathway. On July 06, 2023, the FDA granted Leqembi traditional approval.

Who can use Leqembi?

Leqembi is FDA-approved to treat Alzheimer's disease in patients who have:

• mild cognitive impairment or mild dementia stage of Alzheimer's disease, and
• presence of amyloid beta pathology.

Leqembi can cause serious side effects, including:

Amyloid Related Imaging Abnormalities or “ARIA”. Lecanemab can cause a condition called Amyloid Related Imaging Abnormalities or "ARIA" which is a temporary swelling or small spots of bleeding in the brain that usually clears up with time. Your doctor may perform an MRI of your brain before and during your treatment with lecanemab. Ask your doctor about your risk. If you have ARIA symptoms including confusion, difficulty walking, dizziness, headache, nausea, seizures, vision changes it is important to call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the above symptoms.

You will have your Leqembi treatment in a healthcare setting, it will be given to you by a doctor or nurse.

• Leqembi is a solution (liquid) that is given through a needle placed in a vein (intravenous infusion) in your arm.
• You usually have an infusion every 2 weeks, with each infusion lasting about 1 hour.
• This medicine may cause a severe reaction while having the infusion or shortly after the infusion. See Side Effects above for more information about infusion reactions.
• Your doctor may give you other medicines before receiving Leqembi to help prevent infusion-related reactions.

Usual Leqembi Adult Dose for Alzheimer’s Disease:

• The recommended dosage is 10 mg/kg, which must be diluted and then administered as an intravenous infusion over approximately one hour, once every two weeks.

Leqembi is available as:

• Injection: 500 mg/5 mL (100 mg/mL) in a single-dose vial.
• Injection: 200 mg/2 mL (100 mg/mL) in a single-dose vial.

Monitoring for ARIA

Before starting treatment with this medicine, you should have a recent (within one year) brain magnetic resonance imaging (MRI), and another MRI should be done before the 5th, 7th, and 14th infusions.

To make sure Leqembi is safe for you, tell your healthcare professional if you are allergic to any medicines, including lecanemab-irmb or the inactive ingredients contained in Leqembi.  Click here for a full list of Leqembi ingredients.

Pregnancy

Tell your healthcare provider if you are pregnant, become pregnant or plan to become pregnant. It is not known if Leqembi will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Leqembi, passes into your breast milk. Discuss with your healthcare provider the best way to feed your baby while receiving this medicine.

Common Leqembi side effects include

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

Leqembi can cause serious side effects

Allergic reactions Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Amyloid Related Imaging Abnormalities or “ARIA” See Warnings below.

Infusion-related reactions may occur during the injection. Tell your medical caregiver  immediately if during your infusion you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, flu-like symptoms, fever, or vomiting; chest tightness, fast/slow heartbeats or pounding heartbeats, back pain, trouble breathing, or have swelling in your face.

This is not all the possible side effects. For more information, ask your healthcare provider or pharmacist, or click on the link below for more detailed information on side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

It is important to 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 name of the medicines you take and keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

To check for interactions with this medicine, click the link below.