Leqembi 100 mg/mL concentrate for solution for infusion

Package leaflet: Information for the user

LEQEMBI 100 mg/mL concentrate for solution for infusion

lecanemab

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

–        Keep this leaflet. You may need to read it again.

–        It is important that you keep the patient card with you at all times.

–        If you have any further questions, ask your doctor.

–        If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What LEQEMBI is and what it is used for

2.   What you need to know before you use LEQEMBI

3.   How to use LEQEMBI

4.   Possible side effects

5.   How to store LEQEMBI

6.   Contents of the pack and other information

1.      What LEQEMBI is and what it is used for

What LEQEMBI is

LEQEMBI contains the active substance lecanemab. It belongs to a group of medicines called anti-dementia medicines which are used to treat Alzheimer’s disease. Lecanemab is a monoclonal antibody. These medicines act like the antibodies that your body makes naturally. They work by sticking to harmful target proteins, stimulating the body’s immune system to get rid of the proteins. Lecanemab binds to a protein called amyloid beta, which is involved in Alzheimer’s disease.

Who could take LEQEMBI

LEQEMBI is used to treat mild cognitive impairment or mild dementia due to Alzheimer’s disease (also known as Early Alzheimer’s disease) in adults who carry one copy of a gene called apolipoprotein E4, also known as ApoE4, or in adults who do not carry this gene. Your doctor will perform testing to make sure that LEQEMBI is right for you.

How LEQEMBI works

Alzheimer’s disease is an illness that affects the brain. Amyloid beta clumps damage brain cells and stop them functioning normally. This eventually leads to problems with memory, thinking and behaviour. Alzheimer’s disease symptoms can be different for everyone. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks.

LEQEMBI works by sticking to these clumps and reducing them. For patients with mild cognitive impairment, LEQEMBI could delay the onset of dementia. For people with mild dementia, LEQEMBI may slow the development of more severe symptoms.

2.      What you need to know before you use LEQEMBI

Do not use LEQEMBI

–        if you are allergic to lecanemab or any of the other ingredients of this medicine (listed in section 6).

–        if you have a bleeding disorder that is not being controlled.

–        if your Magnetic Resonance Imaging (MRI), a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body, brain scan shows small spots of bleeding or fluid in the brain or evidence of larger bleeding in the past.

–        If you are receiving medicines (called anticoagulants) to prevent blood clots.

Warnings and precautions

Allergic reactions

Immediately tell the healthcare professional giving you LEQEMBI if you get an allergic reaction during or shortly after you are given LEQEMBI. See section 4 for signs of an allergic reaction.

Amyloid related imaging abnormalities (ARIA)

LEQEMBI can cause a side effect called amyloid related imaging abnormalities, or “ARIA”. There are two main types of ARIA:

–        The build-up of fluid in one or more areas of the brain (this is called ARIA-E).

–        Spots of bleeding in the brain, or on the surface of the brain (this is called ARIA-H).

Most people with ARIA do not experience symptoms. ARIA symptoms may occur in 2 out of 100 people. Symptoms include headache, confusion, dizziness, blurry vision, feeling sick (nausea), difficulty walking or seizures (fits). In a small number of people (less than 1 out of 100 people), these symptoms may be severe.

Contact your doctor urgently if you experience any of these symptoms.

ARIA is visible on an MRI brain scan.

Your doctor will arrange MRI scans before your fifth, seventh and fourteenth doses of LEQEMBI. This is routine safety monitoring to check if you have ARIA. Additional scans might be performed at any time during treatment if your doctor thinks you need them.

Your doctor may stop treatment with LEQEMBI temporarily or permanently, depending on your MRI results.

Genetic risk factors for ARIA

Some people carry a gene called “apolipoprotein E4”, also known as ApoE4. This means they may be at higher risk of ARIA. Your doctor can arrange a genetic test for ApoE4, to see if you are a carrier, and if you are at higher risk of ARIA.

Medicines used to prevent or dissolve blood clots

The risks of having a larger bleed in the brain (known as intracerebral haemorrhage) with LEQEMBI treatment is increased in patients receiving medicines used to prevent blood clots (anticoagulants) or to dissolve them (thrombolytic agents). Tell your doctor that you are being treated with LEQEMBI before you receive any medication to prevent blood clots or dissolve them. LEQEMBI can be used together with aspirin and other medicines that prevent your blood cells sticking together (antiplatelet agents).

Infusion-related reactions

Infusion-related reactions are a very common side effect which can be serious (see section 4 for symptoms). If you have an infusion-related reaction, you may be given medicines before your infusions to decrease your chance of having an infusion-related reaction. These medicines may include antihistamines, paracetamol, anti-inflammatory medicines or steroids. You will be observed for 2.5 hours after your first infusion to monitor for any signs of an infusion-related reaction.

Autosomal Dominant Alzheimer’s disease and adults with Down syndrome

The use of LEQEMBI in the treatment of Autosomal Dominant Alzheimer’s disease and in adults with Down syndrome has not been established.

Mini stroke (transient ischemic attack, TIA), stroke or seizures

Tell your doctor before you are given LEQEMBI if you have had a mini stroke (TIA), stroke or seizure (fit) within the last 12 months. The use of LEQEMBI in patients who have had a mini stroke, stroke or seizure in the past has not been established.

Patients with lowered immune response or taking immunosuppressants

Tell your doctor before you are given LEQEMBI if you have an immunological disorder or if you take any other medicines by injection or medicines that suppress your immune system. The use of LEQEMBI in patients who have a suppressed immune system has not been established.

Children and adolescents

LEQEMBI is not for use in children and adolescents aged less than 18 years.

Other medicines and LEQEMBI

Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular tell your doctor:

–        If you are taking medicines (called anticoagulants) that prevent blood clots. LEQEMBI must not be used with these medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. It is not known if LEQEMBI will harm your unborn baby.

If you are a woman who could become pregnant, you should use contraception during treatment with LEQEMBI and up to 2 months after the last dose of LEQEMBI. The absence of pregnancy will be verified before receiving the treatment.

If you become pregnant while you are using LEQEMBI, tell your doctor. The use of LEQEMBI is not recommended if you are pregnant.

If you are breastfeeding, you and your doctor can discuss if you should carry on with breastfeeding or treatment. It is not known if LEQEMBI passes into breast milk.

Driving and using machines

When taking LEQEMBI, some patients may experience symptoms such as dizziness or confusion. This could affect the ability to drive and use machines. If you are experiencing these side effects due to LEQEMBI, ask your doctor whether you can continue to drive and use machines.

LEQEMBI contains polysorbate 80

This medicine contains 0.5 mg of polysorbate in each 1 mL of LEQEMBI. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains no sodium but the concentrate needs to be diluted with sodium chloride solution, to be taken into consideration for daily dietary intake of sodium.

Patient card

You will also find key messages from this package leaflet on the patient card you have been given by your doctor. It is important that you keep this patient card at all times and show it to your partner or caregivers.

3.      How to use LEQEMBI

LEQEMBI will be given to you under the supervision of a healthcare professional.

Dosage

The recommended dose is 10 milligrams per kilogram of your body weight (mg/kg). It should be given to you every 2 weeks.

LEQEMBI is given as a ‘drip’ (a needle placed in your vein) also called an intravenous (IV) infusion. Each infusion will last approximately 1 hour.

If you miss an infusion of LEQEMBI

If you miss an infusion of LEQEMBI, talk to your doctor to arrange to have it as soon as possible. Do not wait until your next planned infusion.

When to stop using LEQEMBI

Your doctor may recommend pausing or stopping treatment, depending on your clinical test results, if you develop ARIA, or experience other side effects.

If you have any further questions on the use of this medicine, ask your doctor.

4.      Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with LEQEMBI:

Serious side effects

Up to 1 in 10 people may experience the following side effect:

–          An allergic reaction while or shortly after you are given this medicine. Signs of an allergic reaction include swelling underneath the skin, difficulty breathing caused by narrowing of the airways, serious potentially life-threatening allergic reaction, rash and headache.

Up to 1 in 100 people may experience the following side effect:

–          Large areas of bleeding in the brain (known as intracerebral haemorrhages). This can cause symptoms including severe headaches, confusion, seizures or stroke.

Contact your doctor urgently if you experience these side effects.

Other side effects

Over 1 in 10 people may experience the following side effects:

–          Infusion-related reactions. Signs include fever, flu-like symptoms such as chills, body aches,

feeling shaky and joint pain, feeling sick (nausea), being sick (vomiting), low blood pressure, high blood pressure or low oxygen in your blood which can cause difficulty breathing or

shortness of breath, changes in your heart rate, feeling like your chest is pounding or restlessness.

–          Headache.

–          ARIA. Signs of ARIA include headache, confusion, dizziness, blurry vision, feeling sick

(nausea), difficulty walking or seizures (fits). One of two main types of ARIA, ARIA-H is linked to small areas of bleeding in the brain.

Up to 1 in 10 people may experience the following side effects:

–          Delayed allergic reactions. Signs include rash, headache, runny nose, and hair loss.

–          ARIA-E, linked to temporary fluid build-up in one or more regions of the brain. See signs of ARIA above.

–          Abnormal heart rhythm (this is called atrial fibrillation). Signs include irregular heartbeat (racing or fluttering in your chest), chest pain, shortness of breath, dizziness or feeling faint, tiredness, or finding it harder to exercise.

–          Feeling sick (nausea).

Talk to your doctor about how to manage these side effects.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance: www.hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5.      How to store LEQEMBI

–               Keep this medicine out of the sight and reach of children.

–               Do not use this medicine after the expiry date which is stated on the carton and the vial label after ‘EXP’. The expiry date refers to the last day of that month.

–               Store in the original package in order to protect from light.

–               Store in a refrigerator (2 °C - 8 °C). Do not freeze or shake.

–               After dilution, an immediate use is recommended. Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C. From a microbiological point of view, unless the method of dilution precludes the risks of microbial contamination, the product should be used immediately. If not use immediately, in-use storage times and conditions are the responsibility of the user.

6.      Contents of the pack and other information

What LEQEMBI contains

–               The active substance is lecanemab. Each mL of concentrate contains 100 mg lecanemab.

–               The other ingredients are water for injections, histidine hydrochloride monohydrate, arginine hydrochloride and polysorbate 80.

What LEQEMBI looks like and contents of the pack

LEQEMBI is a concentrate for solution for infusion. Each carton contains 1 vial of 2 ml concentrate or 1 vial of 5 ml concentrate. The concentrate is clear to slightly opalescent, colourless to pale yellow.  

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

e-mail: medinfo_de@eisai.net

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Eisai SA/NV

Tél/Tel: + 32 (0) 2 502 58 04

Lietuva

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

България

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Luxembourg/Luxemburg

Eisai SA/NV

Tél/Tel: + 32 (0) 2 502 58 04

(Belgique/Belgien)

Česká republika

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Magyarország

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Danmark

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Malta

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Deutschland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

Nederland

Eisai B.V.

Tel: + 31 (0) 900 575 3340

Eesti

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Norge

Eisai AB

Tlf: + 46 (0) 8 501 01 600

(Sverige)

Ελλάδα

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Österreich

Eisai GesmbH

Tel: + 43 (0) 1 535 1980-0

España

Eisai Farmacéutica, S.A.

Tel: + (34) 91 455 94 55

Polska

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

France

Eisai SAS

Tél: + (33) 1 47 67 00 05

Portugal

Eisai Farmacêutica, Unipessoal Lda

Tel: + 351 214 875 540

Hrvatska

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

România

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Ireland

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Slovenija

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Ísland

Eisai AB

Sími: + 46 (0) 8 501 01 600

(Svíþjóð)

Slovenská republika

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Italia

Eisai S.r.l.

Tel: + 39 02 5181401

Suomi/Finland

Eisai AB

Puh/Tel: + 46 (0) 8 501 01 600

(Ruotsi/Sverige)

Κύπρος

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

Sverige

Eisai AB

Tel: + 46 (0) 8 501 01 600

Latvija

Eisai GmbH

Tel: + 49 (0) 69 66 58 50

(Germany)

This leaflet was last revised in 15/04/2025.

LeqEU/0001/2025

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.

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The following information is intended for healthcare professionals only:

See section 3 for Posology of the medicine.

Instructions for preparation

LEQEMBI is for single use only.

LEQEMBI is a concentrate and must be diluted prior to infusion.

Calculating the dose

More than one vial of LEQEMBI concentrate may be needed to give the total dose for the patient.

The prescribed dose for the patient is given in mg/kg (see section 3). Based on this prescribed dose, calculate the total dose to be given.

The total LEQEMBI dose in mg = the patient's weight in kg × the prescribed dose in mg/kg.

The volume of LEQEMBI concentrate to prepare the dose (mL) = the total dose in mg, divided by 100 (the LEQEMBI concentrate strength is 100 mg/mL).

Preparing the LEQEMBI infusion

Aseptic technique should be used when preparing the LEQEMBI diluted solution for intravenous infusion.

–               Check that the LEQEMBI liquid is clear to slightly opalescent and colourless to pale yellow.

–               Withdraw the required volume of LEQEMBI from the vial(s) and add to 250 mL 0.9% sodium chloride solution for injection.

–               Gently invert the infusion bag containing the LEQEMBI diluted solution to mix completely. Do not shake.

–               Infusion bags manufactured using polypropylene, polyvinyl chloride, co-extruded polyolefin/polyamide, or ethylene/propylene copolymer have been confirmed to be compatible for administration of lecanemab.

–               After dilution, an immediate use is recommended. Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C.  From a microbiological point of view, unless the method of dilution precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. 

–               Prior to infusion, allow the LEQEMBI diluted solution to warm to room temperature.

–               Any unused product or waste material should be disposed of in accordance with local requirements.

Method of administration

LEQEMBI is for intravenous use only.

LEQEMBI is diluted prior to intravenous infusion (as per above instructions for preparation).

The diluted medicinal product should be visually inspected for particles or discolouration prior to administration. Do not use if it is discoloured or if opaque particles are seen.

The diluted solution is infused through an intravenous line over approximately 1 hour. Use of a sterile, low-protein binding 0.2 micron in‑line filter (compatible filter materials include polytetrafluoroethylene, polyethersulfone, polycarbonate, polyvinylidenedifluoride, polypropylene, polyurethane and polysulfone) is recommended.