Leqembi
Pronunciation: leh-kem’-bee
Generic name: lecanemab-irmb
Dosage form: injection for intravenous use
Drug class: Miscellaneous central nervous system agents
What is Leqembi?
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 side effects
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.
Related/similar drugs
donepezil, memantine, Aricept, Namenda, rivastigmine, Exelon
Warning
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.
Before receiving Leqembi
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.
How will I receive Leqembi?
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.
Dosing information
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.
What other drugs will affect Leqembi?
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.
Ingredients
Active ingredient: lecanemab-irmb.
Inactive ingredients: arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polysorbate 80, and water for injection.
Storage
Unopened Vial
- Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
- Store in the original carton to protect from light.
- Do not freeze or shake.
After dilution
- Immediate use is recommended
- If not administered immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours, or at room temperature up to 30°C (86°F) for up to 4 hours.
- Do not freeze.
Manufacturer
Eisai Inc., Nutley, NJ 07110
Popular FAQ
Who makes and manufactures Leqembi (lecanemab-irmb)?
Leqembi is manufactured by Eisai Inc. based in Nutley, NJ, USA. You can contact Eisai at 1-888-274-2378 or online at EisaiPatientSupport.com/Leqembi.
What are monoclonal antibodies?
Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading
What's the mechanism of action for Leqembi (lecanemab-irmb)?
Leqembi (lecanemab-irmb) is an anti-Aβ protofibril antibody and has been shown to reduce brain amyloid and modestly slow cognitive decline in adult patients with early Alzheimer disease. It is thought to slow down the progression of Alzheimer by neutralizing and eliminating the toxic amyloid-beta aggregates found in the brain. Continue reading
Will insurance cover Kisunla treatment?
Kisunla treatment typically requires a prior authorization approval from your commercial insurance company before they will pay for it. Medicare Part B may pay for Kisunla and brain imaging scans if you are eligible, but you must first meet your yearly deductible and then pay coinsurance costs, which are usually 20%. Continue reading
How well does Kisunla work?
In studies, treatment with Kisunla significantly slowed Alzheimer's disease clinical decline when compared to a group who received a placebo. People with the least advanced disease experienced the strongest outcomes, with a 35% slowing of decline on the iADRS score, which measures memory, thinking, and daily functioning. Continue reading
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