Lecanemab is used to treat adults with Alzheimer's disease.

Lecanemab may also be used for purposes not listed in this medication guide.

Lecanemab can cause temporary swelling or bleeding in the brain that usually clears up with time. This condition may cause no symptoms but can be serious. Call your doctor if you have headaches, dizziness, nausea, confusion, trouble with walking, seizures, or vision changes.

Lecanemab is injected into a vein by a healthcare provider.

This medicine is injected slowly over 1 hour every 2 weeks.

You may be given other medications to help prevent serious side effects or allergic reaction.

Store this medicine in the refrigerator in the original container, do not freeze or shake.

Usual Adult Dose for Alzheimer's Disease:

IV infusion of 10 mg/kg over approximately 1 hour, once every two weeks

Comments:
-This drug is approved under accelerated approval based on reductions in amyloid beta plaques observed in patients treated.
-Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
-Presence of amyloid beta pathology should be confirmed before starting this treatment.

Use: Alzheimer's disease

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.

It is not known if lecanemab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using lecanemab.

Call your doctor for instructions if you miss an appointment for your lecanemab injection.

In a medical setting an overdose would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if 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 swelling in your face.

Common side effects of lecanemab may include:

• ARIA with symptoms or with signs that appear on an MRI;

• infusion-related reactions; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially medicines to treat or prevent blood clots, including aspirin.

Other drugs may affect lecanemab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.