Kisunla (donanemab) - Penn Memory Center

What is Kisunla (donanemab)?

Kisunla is a drug developed to reduce amyloid plaques associated with early symptomatic Alzheimer’s disease (AD). In clinical trials, Kisunla was found to significantly slow the progression of memory and thinking issues in individuals with early AD.

Donanemab is the scientific name of the drug. It is marketed as Kisunla.

Who Is Eligible for Kisunla?

Kisunla is prescribed for adults in the early symptomatic stages of Alzheimer’s disease, which includes:

Mild cognitive impairment (MCI) due to Alzheimer’s disease
Mild-stage dementia due to Alzheimer’s disease

How Does Kisunla Work?

Patients with Alzheimer’s disease have a buildup of a protein called amyloid-beta in the brain called amyloid plaques. Kisunla is an antibody that binds to and removes amyloid plaques.

In clinical trials, Kisunla helped reduce amyloid plaques by:

61% in 6 months
80% in 12 months
84% in 18 months

While Kisunla does not reverse memory loss, it has been shown to slow the progression of cognitive decline and help people with Alzheimer’s maintain their daily activities for longer. After 18 months, those taking Kisunla experienced, on average, 22% less decline compared to those who received a placebo.

How is Kisunla Administered?

Kisunla is given as a once-monthly intravenous (IV) infusion by a healthcare provider.

What to expect:

Infusion frequency: Every four weeks
Infusion length: Around 30 minutes
Post-infusion monitoring: Patients stay for at least 30 minutes for observation
Treatment length: Varies based on individual amyloid plaque levels. In a clinical study, 17% of people were able to stop taking Kisunla at 6 months, 47% at 12 months, and 69% at 18 months if their amyloid plaques were reduced to a predefined level. Your doctor will determine how long you should continue treatment based on amyloid levels detected via PET scan.

How Do I Know if I Qualify for Kisunla?

Eligibility is determined through several assessments, including:

Cognitive evaluation by your doctor
MRI scans to check for amyloid-related imaging abnormalities (ARIA)
Blood tests to rule out other causes of cognitive impairment
APOE genetic testing to assess potential treatment risks
Testing for the presence of amyloid via PET scan or lumbar puncture

How Much Does Kisunla Cost?

In a news release, the manufacturers of Kisunla announced a yearly price of $32,000 for the drug. The annual cost to you will be determined by insurers.

What is the APOE Gene?

The APOE gene affects both your risk of developing Alzheimer’s disease and your chances of experiencing side effects from Kisunla. There are three common versions of this gene: e2, e3, and e4. People who carry the e4 version may have a higher risk of developing amyloid-related imaging abnormalities (ARIA)—a possible side effect of Kisunla.

To help determine if Kisunla is a safe option, Penn Medicine tests eligible patients for the APOE ε4 gene to assess their risk for ARIA. Knowing your APOE status can help you and your doctor make an informed decision about treatment.

What Are the Side Effects of Kisunla?

The most common side effects include:

ARIA (Amyloid-Related Imaging Abnormalities): Brain swelling and micro-hemorrhages (small bleeds), which may not cause symptoms but require monitoring. Although most people do not have symptoms, some people have headache, confusion, dizziness, vision changes, nausea, difficulty walking, or seizures.
Some individuals may experience allergic reactions or infusion-related reactions, which can include swelling of the face, lips, or mouth; difficulty breathing; hives, chills, nausea, or vomiting.

Your healthcare provider will monitor for these side effects and provide guidance.

Learn more about Kisunla side effects

Kisunla Treatment Requirements

In addition to monthly infusions, patients receiving Kisunla need:

MRI scans at 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months, and 18 months of treatment to monitor for ARIA
Careful monitoring for side effects, via visits with your doctor every 6 months

More Information and Support

For specific questions regarding your condition or the condition of a loved one, please contact your physician or make an appointment with the clinicians at Penn Memory Center. For general questions, you can reach the Penn Memory Center at pennmemorycenter@pennmedicine.upenn.edu.

Resources from Kisunla.lilly.com

Kisunla in the News

FDA approves treatment for adults with Alzheimer’s disease, FDA.gov
New Drug Approved for Early Alzheimer’s, The New York Times

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