A new starting dosage regimen for the subcutaneous (under the skin) version of lecanemab-irmb (Leqembi) has been approved by the U.S. Food and Drug Administration (FDA). The FDA based its approval for the new regimen on evidence that the under-the-skin version produced similar results to the intravenous (IV) formulation.

Until now, Leqembi, a treatment for adults with Alzheimer’s, started with an IV infusion every two weeks, which required going to an infusion center or hospital outpatient department. After 18 months, people could continue with infusions or switch to a subcutaneous formulation taken at home.

The new approval makes it possible to start with the at-home under-the-skin version, once a person has received two subcutaneous versions in a row under guidance from a healthcare provider.

For people weighing treatment options for Alzheimer’s, this approval adds a more flexible way to start therapy.

What Is Leqembi?

Leqembi is an amyloid beta-directed monoclonal antibody used for adults with Alzheimer’s, in the mild cognitive impairment or mild dementia stage of the disease. It works by targeting amyloid beta plaques in the brain.

The drug was first approved in January 2023.

What Are the Possible Side Effects?

Like all treatments, Leqembi can cause side effects. The most common side effects are:

• Headache
• Infusion-related reactions
• Amyloid-related imaging abnormalities (ARIA), which can involve swelling or small areas of bleeding in or on the brain
• Injection-related reactions for the subcutaneous version

The drug also has a boxed warning about ARIA, which can, in rare instances, be serious or life-threatening. ApoE4 testing should be performed before starting treatment to help inform ARIA risk. The agency also recommends caution for people taking anticoagulants because brain bleeds can occur.

Why This Approval Matters for People With Alzheimer’s

For some people with early Alzheimer’s disease and their families, repeated clinic infusions can be a hurdle. Travel, scheduling, and caregiving logistics can all make treatment harder to begin.

This approval does not make Leqembi right for everyone, and it does not remove the need for risk discussions and monitoring. But it may make treatment more manageable by allowing it to take place at home early on instead of at an infusion center.

If you’re caring for someone with Alzheimer’s disease, talk with a healthcare provider about whether this treatment option fits their stage of disease, test results, care plan, and monitoring needs.

Join the Conversation

On myALZteam, people share their experiences with Alzheimer’s, get advice, and find support from others who understand.

Would starting treatment at home make a difference for you or your loved one? Let others know in the comments below.