Patient Medication Information: uses, side effects, how to take - Leqembi

Serious warnings and precautions box

LEQEMBI can cause serious side effects that can be life-threatening or lead to death. The serious adverse effects of LEQEMBI include the following:

Amyloid Related Imaging Abnormalities: or “ARIA” 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 although serious and life-threatening events leading to death can occur. Some people may have symptoms, such as: headache, confusion, dizziness, vision changes, nausea (feeling sick), difficulty walking, seizures or stroke-like symptoms. ARIA with swelling most commonly occurs during the first 14 weeks of treatment.
Intracerebral hemorrhages > 1 cm: larger areas of bleeding in the brain were observed in patients treated with LEQEMBI, some of which have been fatal. Your healthcare professional will conduct proper diagnosis and assess the risk before you take medicines to dissolve blood clots (thrombolytic therapy), as these medications can worsen the bleeding in your brain.
Genetic risk factor: some people carry a gene called apolipoprotein E ε4 (ApoE ε4) that increases the risk for ARIA. Your healthcare professional will discuss this with you and arrange a genetic test to ensure that LEQEMBI is suitable for you.

Your healthcare professional will monitor for these signs and symptoms during treatment with LEQEMBI using MRI brain scans. Talk to your healthcare professional right away if you develop any of these symptoms at any time during your treatment with LEQEMBI.

Carry identification that states you are taking LEQEMBI and consider wearing a medical alert bracelet.

What LEQEMBI is used for:

For the following indication LEQEMBI has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional.

LEQEMBI is used to treat the early stages of Alzheimer’s disease in adults who do not carry a gene called apolipoprotein E ε4, also known as ApoE4, or in adults who carry one copy of this gene. Your healthcare professional will perform testing to make sure that LEQEMBI is right for you.

A Canadian registry has been established to monitor the safety of LEQEMBI in the real-world setting. Healthcare professionals should enroll patients in the registry at the time of treatment initiation. Information regarding the registry program may be found at [leqembicanada.ca].

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

What is a Notice of Compliance with Conditions (NOC/c)?

A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.

Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.

Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.

How LEQEMBI works:

LEQEMBI contains the active substance lecanemab. Lecanemab works by binding, slowing, and reducing plaque formation of a protein called amyloid beta. Clumps of this protein in the brain are believed to cause Alzheimer’s disease.

The ingredients in LEQEMBI are:

Medicinal ingredients: lecanemab

Non-medicinal ingredients: arginine hydrochloride, histidine/histidine hydrochloride monohydrate, polysorbate 80, and Water for Injection.

LEQEMBI comes in the following dosage forms:

Lecanemab is available as a solution in 2 strengths, 200 mg/2mL and 500 mg/5mL.

Do not use LEQEMBI if:

you are allergic to lecanemab, or any of the other ingredients of LEQEMBI (see The ingredients in LEQEMBI are).
you carry two copies of a gene called apolipoprotein E ε4, also known as the ApoE4 gene. • your Magnetic Resonance Imaging (MRI) brain scan shows small spots of bleeding or fluid in the brain, or evidence of larger bleeding in the past.
you are receiving medicines (called anticoagulants) to prevent blood clots.
you have bleeding disorders that are not being properly managed or treated.
you have serious health problems—like heart, lung, or kidney issues—that are not stable or well managed.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LEQEMBI. Talk about any health conditions or problems you may have, including if you:

are pregnant or plan to become pregnant. It is not known if LEQEMBI will harm your unborn baby. Tell your healthcare professional if you become pregnant during your treatment with LEQEMBI.
are breastfeeding or plan to breastfeed. It is not known if lecanemab (the active ingredient in LEQEMBI) passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby while receiving LEQEMBI.

Other warnings you should know about:

Disease progression

Your healthcare professional will stop treatment with LEQEMBI if your Alzheimer’s disease gets worse.

Driving and using machines

Some patients may experience symptoms such as dizziness or confusion. This could affect the ability to drive and use machines, therefore, caution is recommended.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

LEQEMBI can be used alone, or together with other medicines that treat symptoms of Alzheimer’s disease.
Especially tell your healthcare professional if you take medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). Ask your healthcare professional for a list of these medicines if you are not sure.
Tell your healthcare professional that you are being treated with LEQEMBI before you receive any medication to prevent blood clots or dissolve them.

How to take LEQEMBI:

LEQEMBI will be given to you under the supervision of a healthcare professional experienced in the diagnosis and treatment of Alzheimer’s disease with timely access to MRI.
Your healthcare professional will confirm that you have amyloid in your brain through a Positron Emission Tomography (PET) scan or a lumbar puncture (spinal tap).
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.
Your healthcare professional may recommend taking a pain-relieving medication, antihistamine or corticosteroid before your infusion to help prevent an infusion-related reaction.

Patients treated with LEQEMBI must be given the Patient Alert Card. Additional educational materials have been developed for patients and caregivers. These can be accessed at [leqembicanada.ca].

Usual dose:

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

Your healthcare professional will arrange MRI scans before you start treatment and before your 3^rd, 5^th, 7^thand 14^thdoses of LEQEMBI. Your MRI should be done about a week before your dose, so your healthcare professional can look at the results before your dose. This is routine monitoring to check if you have ARIA. Additional scans can be performed at other times during treatment if a healthcare professional thinks you need them.

Your healthcare professional may permanently stop or pause treatment temporarily, depending on your MRI results.

Overdose:

If you think you, or a person you are caring for, have taken too much LEQEMBI, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

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

Possible side effects from using LEQEMBI:

These are not all the possible side effects you may have when taking LEQEMBI. If you experience any side effects not listed here, tell your healthcare professional.

Very common side effects (may affect more than 1 in 10 people) included fall and headache. Common side effects (may affect more than 1 in 100 people) included back pain, nausea (feeling sick), vomiting, anxiety, runny nose, sneezing, tiredness and rash.

Serious side effects and what to do about them

Frequency /Side Effects/Symptom	Talk to your healthcare professional		Stop taking the/this drug (if applicable) and get immediate medical help
Only if severe	In all cases
Very Common		Superficial siderosis of the central nervous system seen on MRI images: small spots of bleeding on the surface of the brain: headache; dizziness	X
Frequency /Side Effects/Symptom	Talk to your healthcare professional		Stop taking the/this drug (if applicable) and get immediate medical help
Only if severe	In all cases
Infusion-related reactions: fever, flu-like symptoms such as chills, body aches, feeling shaky and joint pain, feeling sick (nausea), being sick (vomiting), dizziness or light-headedness, changes in your heart rate or feeling like your chest is pounding, difficulty breathing or shortness of breath.	X
Finding of ARIA-H on brain images: small spots of bleeding in the brain: headache; dizziness			X
Common
Finding of ARIA-E on brain images: which can be fluid in one or more regions on the brain: headache; confusion; dizziness; vision changes; nausea (feeling sick); change in pattern of walking or seizures or stroke-like symptoms; however, most people may not experience any symptoms.			X
Atrial fibrillation (abnormal heart rhythm): irregular heartbeat (racing or fluttering in your chest), chest pain, shortness of breath, dizziness or feeling faint,			X
Frequency /Side Effects/Symptom	Talk to your healthcare professional		Stop taking the/this drug (if applicable) and get immediate medical help
Only if severe	In all cases
tiredness, or finding it harder to exercise.
Rare
Intracerebral hemorrhage (>1cm): (areas of larger bleeds in the brain): severe headaches, confusion, seizures, altered consciousness or weakness/numbness in face, arm or leg (usually on one side), vision changes.			X

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

LEQEMBI will be stored by healthcare professionals.

This medicine is not to be used after the expiry date which is stated on the outer carton and the
vial label after ‘EXP’. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C). Do not freeze or shake.
Store in the outer carton in order to protect from light.

Keep out of reach and sight of children.

If you want more information about LEQEMBI:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website eisai.ca, or by calling 1-877-873-4724.

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

Date of Authorization: October 24, 2025

Rx or OTC	Prescription (Rx)?
DIN	02562383
Schedule(s)	SCHEDULE D; PRESCRIPTION
Active ingredient(s)	Lecanemab 100 MG
Dosage form(s)	Solution
Route(s) of administration	Intravenous
Drug class (WHO ATC)	N Nervous system drugs N06 Psychoanaleptics N06D Anti-dementia drugs N06DX Other anti-dementia drugs N06DX04 Lecanemab
Company	EISAI LIMITED
Current status	Marketed
Current status date	December 16, 2025

Leqembi: Uses, Side Effects and Dosage