Lecanemab-irmb (Intravenous)

Lecanemab-irmb injection is used to treat Alzheimer's disease.

This medicine must be given only by or under the supervision of your doctor.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause amyloid related imaging abnormalities (ARIA), which can show up as temporary swelling or bleeding in the brain. Call your doctor right away if you have changes in vision, confusion, dizziness, headache, nausea, or seizures.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have back pain, blurred vision, chest tightness, chills, confusion, cough, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, drowsiness, fever, flushing, a general feeling of discomfort or illness, headache, joint pain, muscle aches and pains, nausea and vomiting, nervousness, pale skin, pounding in the ears, runny nose, shivering, slow or fast heartbeat, sore throat, sweating, trouble breathing, trouble sleeping, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a cough, difficulty swallowing, dizziness, fast heartbeat, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs, rash, itching, trouble breathing, or unusual tiredness or weakness after receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it may provide. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to determine how age affects the use of lecanemab-irmb injection in children. Safety and effectiveness have not been established.

Geriatric

So far, studies have not found any specific issues in older adults that would limit the effectiveness of lecanemab-irmb injection.

Breast Feeding

There are no sufficient studies in women to assess the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medications should not be used together at all, while in other cases, two different medicines can be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose, or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with specific types of food because interactions might happen. Using alcohol or tobacco with certain medicines can also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Back pain
• blurred or changes in vision
• chest tightness
• chills
• confusion
• diarrhea
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• feeling shaky
• fever
• flushing
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pain
• nausea and vomiting
• nervousness
• pale skin
• pounding in the ears
• runny nose
• seizures
• shivering
• slow or fast heartbeat
• sore throat
• sweating
• trouble breathing
• trouble sleeping
• unusual tiredness or weakness

Less common

• Cough or hoarseness
• lower back or side pain
• painful or difficult urination

Incidence not known

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Leqembi

Available Dosage Forms:

• Solution

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Lecanemab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 1 hour. This medicine is usually given every 2 weeks.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Your doctor will do magnetic resonance imaging (MRI) scans before the first treatment, and at certain times during treatment with this medicine.

Your doctor may give you other medicines (eg, allergy medicine, NSAID, steroid medicine) before receiving this medicine to help prevent infusion-related reactions.

Missed Dose

Call your doctor or pharmacist for instructions.

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