Leqembi (lecanemab-irmb) 500 mg/5 mL (100 mg/mL) injection

Description

Leqembi’s mechanism of action involves targeting and removing beta-amyloid plaques in the brain. Beta-amyloid is a protein that abnormally buildups in the brains of people with AD and is thought to contribute to the progression of the disease.

Leqembi side effects

The most common side effects of Leqembi are:

• infusion-related reactions, which can be serious
• headache
• swelling in areas of the brain, with or without small bleeding spots in or on the brain’s surface (ARIA).

Serious side effects and warnings

Leqembi may cause serious side effects and one Leqembi controversy relates to the risk of brain swelling and bleeding. Leqembi carries a Boxed Warning for Amyloid-related imaging abnormalities.

Amyloid Related Imaging Abnormalities or “ARIA”. Leqembi can cause a condition called ARIA which does not usually cause any symptoms but serious symptoms can occur. ARIA 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 with this type of swelling in the brain do not get symptoms, however, some people may have symptoms, such as headache, confusion, dizziness, vision changes, nausea, difficulty walking, or seizures.

Some people have a genetic risk factor (homozygous apolipoprotein E gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor.

Some medicines can increase the risk for larger areas of bleeding in the brain in patients taking Leqembi. Talk to your healthcare provider to see if you are on any medicines that increase this risk.

Your healthcare provider will do magnetic resonance imaging (MRI) scans before and during your treatment with
Leqembi to check you for ARIA. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

Serious allergic reactions. Swelling of the face, lips, mouth, or tongue, hives, or difficulty breathing has happened during a Leqembi infusion. Tell your healthcare provider if you have any symptoms of a serious allergic reaction during or after your infusion.

Infusion-related reactions. Infusion-related reactions are a common side effect that can be serious. Tell
your healthcare provider right away if you get these symptoms during an infusion of Leqembi:

• fever
• flu-like symptoms (chills, body aches, feeling shaky, and joint pain)
• nausea
• vomiting
• dizziness or lightheadedness
• changes in your heart rate or feel like your chest is pounding
• difficulty breathing or shortness of breath.