Lecanemab-irmb injection may cause a serious or life-threatening reaction called amyloid related imaging abnormalities (ARIA; a condition that may cause swelling and bleeding in the brain). If you experience any of the following symptoms, tell your doctor immediately or get emergency medical treatment: headache, confusion, dizziness, vision changes, nausea, difficulty walking or loss of balance, muscle weakness, difficulty speaking, or seizures.
Always carry identification stating that you are receiving lecanemab-irmb injection. If you need an identification card, ask your pharmacist or doctor how to get one.
The chance that you will develop ARIA during your treatment with lecanemab-irmb may be higher if you have a genetic (inherited) risk factor. Your doctor may order a blood test to help decide if this medication is right for you. Tell your doctor if you are taking medications that may cause bleeding.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests such as magnetic resonance imaging (MRI; a medical test that uses powerful magnets to take pictures of the inside of the body) scans before and during treatment to check your body's response to lecanemab-irmb.
You will be given the Medication Guide when you begin treatment with lecanemab-irmb injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.Why is this medicine prescribed?
Lecanemab-irmb injection is used to treat Alzheimer's disease (a brain disorder that affects memory, thinking, and behavior) in patients with mild disease. Lecanemab-irmb is in a class of medications called monoclonal antibodies. It works by reducing amyloid beta plaques, abnormal proteins that develop in the brain and contribute to the progression of Alzheimer's disease.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Lecanemab-irmb injection comes as a solution (liquid) to infuse intravenously (into a vein) over about an hour by a doctor or nurse in a healthcare setting. lt is given every 2 or 4 weeks. Lecanemab-irmb injection also comes as a solution in a prefilled autoinjector to inject subcutaneously (under the skin). It is given subcutaneously every 4 weeks.
Use lecanemab-irmb injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
You will receive your first subcutaneous dose of lecanemab-irmb injection in your doctor's office. After that, you may be allowed to give the injections at home. Make sure you read the written instructions that come with it. Ask your doctor or pharmacist to show you or a caregiver how to inject it.
Use each autoinjector only once. Dispose of used needles in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.
Remove the autoinjector from the refrigerator. Place it on a flat surface. Allow it warm to room temperature for 20 minutes before you inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.
Do not remove the cap from the autoinjector until you are ready to inject lecanemab-irmb. Do not replace the cap after you remove it. Do not use the autoinjector if you drop it on the floor or if it is cracked or broken.
Always look at lecanemab-irmb solution before you inject it. Check that the expiration date has not passed and the liquid is be clear to colorless or pale yellow. Do not use lecanemab-irmb injection if it is cloudy, discolored, or has solid particles. Do not shake it.
You can inject lecanemab-irmb injection anywhere on the front of your thighs (upper leg) or stomach except your navel (belly button) and the area 2 inches (5 centimeters) around it. If a caregiver injects the medication, the back of the upper arm may also be used. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.
If lecanemab-irmb injection is given intravenously, it may cause serious reactions during or shortly after the infusion. A doctor or nurse will watch you carefully while you receive the medication. You may be given other medications to help prevent and treat reactions. If you experience any of the following symptoms, tell your doctor immediately: fever, chills, body aches, joint pain, nausea, vomiting, dizziness or lightheadedness, fast or pounding heartbeat, or difficulty breathing or shortness of breath.
Your doctor may need to interrupt your treatment or stop your treatment depending on your response to the medication and any side effects that you experience. Be sure to tell your doctor how you are feeling during your treatment.
Lecanemab-irmb controls Alzheimer's disease but does not cure it. Do not stop using lecanemab-irmb without talking to your doctor.
What special precautions should I follow?
Before receiving lecanemab-irmb injection,
- tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving lecanemab-irmb injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- the following nonprescription product may interact with lecanemab-irmb injection: aspirin. Be sure to let your doctor and pharmacist know that you are taking this medication before you start receiving lecanemab-irmb injection. Do not start this medication while receiving lecanemab-irmb injection without discussing with your healthcare provider.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking lecanemab-irmb, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
If you miss an appointment to receive lecanemab-irmb injection, call your healthcare provider as soon as possible.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Lecanemab-irmb injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- cough
- diarrhea
- redness, swelling, pain, itching, rash, bruising, or bleeding at the injection site
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- hives; rash; itching; swelling of the lips, tongue, or throat; shortness of breath or difficulty breathing
- headache, fatigue, or fever (during or after a subcutaneous injection)
Lecanemab-irmb may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
Store lecanemab-irmb autoinjectors in the original container in the refrigerator and protect from light. Do not freeze. If needed, lecanemab-irmb injection may be stored at room temperature in the original carton and away from excess heat and moisture (not in the bathroom) for up to 14 days. Once stored at room temperature, do not return the medication to the refrigerator.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.