Kisunla

Kisunla is a prescription medicine used for Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia. Kisunla helps slow down the decline in memory, thinking, and daily functioning, which slows Alzheimer’s disease progression, and people can continue living their lives doing their daily activities and hobbies for a longer time.

Alzheimer's disease symptoms are thought to be related to clumps of amyloid protein (amyloid plaques) that can occur in the brain. Kisunla is an anti-amyloid treatment that works by reducing amyloid beta plaques in the brain, which slows the progression of Alzheimer’s disease. Kisunla is called an amyloid beta-directed antibody.

Kisunla (donanemab) is administered as a once-monthly IV infusion that takes approximately 30 minutes. The dose is increased slowly over the first 4 infusions to reduce the risk of side effects.

Kisunla FDA approval was granted on July 2, 2024, to Eli Lilly and Company after positive results from the TRAILBLAZER-ALZ 2 clinical trial.

Kisunla (donanemab) significantly slowed Alzheimer's disease progression by more than 20% at 76 weeks in the TRAILBLAZER-ALZ 2 clinical trial. This was measured using the Integrated Alzheimer’s Disease Rating Scale (iADRS) and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score in patients with low/medium tau and in the combined low/medium and high tau populations.

Treatment with Kisunla benefited all groups of trial participants, but patients in earlier stages of the disease showed the most significant improvements.

Kisunla is administered as an infusion into a vein (IV infusion) in your arm, which will last about 30 minutes. Kisunla is given every 4 weeks with an initial increasing dosing schedule. If you miss an infusion, you should receive your next dose as soon as possible.

Kisunla can cause serious side effects, including:

Amyloid Related Imaging Abnormalities or ARIA.

ARIA is a common side effect that does not usually cause any symptoms, but sometimes serious symptoms can occur. ARIA can be fatal. It is most commonly seen in an MRI 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 who develop ARIA do not have symptoms; however, some people may have symptoms such as headache, dizziness, nausea, difficulty walking, confusion, vision changes, and seizures.

If you have any of the symptoms of ARIA listed above, you should call your healthcare provider or go to the nearest hospital emergency room right away.

You are more at risk of ARIA if you have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers). Your healthcare provider may test to see if you have this risk factor.

If you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla, you may be at a higher risk of developing bleeding in the brain.

Magnetic resonance imaging (MRI) scans are done before and during your treatment to check you for ARIA.

You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms.

There are registries that collect information on treatments for Alzheimer’s disease. Your healthcare provider can help you become enrolled in these registries.

Consider the risk of ARIA and the benefit of Alzheimer's disease when deciding to treat with Kisunla.

You should not receive this medicine if you have had serious allergic reactions to donanemab-azbt or any of the ingredients in this infusion. See the end of this document for a complete list of ingredients.

Pregnancy

Tell your healthcare provider if you plan to become pregnant, become pregnant, or are pregnant, as it is not known if this medicine will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed, as it is not known if the active ingredient in Kisunla passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving this medicine.

Common Kisunla side effects

Common Kisunla side effects include headache and swelling in areas of the brain with or without small spots of bleeding in or on the brain's surface. These occurred in at least 10% of patients and at a higher incidence compared to placebo.

Serious Kisunla side effects

• Serious allergic reactions include swelling of the face, lips, mouth, or eyelids, difficulty breathing, and hives. Tell your healthcare provider if you have any symptoms of a serious allergic reaction during or after your infusion.
• Infusion-related reactions. If you have an infusion-related reaction, your infusion may be slowed down or stopped. Tell your healthcare provider right away if you have symptoms of sweating, irritation of the skin, headache, nausea, chest pain, vomiting, or problems breathing during an infusion chills. If you have had an infusion-related reaction while receiving Kisunla, your healthcare provider may give you an antihistamine, acetaminophen, or a steroid before your infusions to decrease your risk of having an infusion reaction.

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 the FDA at 1-800-FDA-1088.

Also, see the Warning section

Kisunla is given every 4 weeks with an initial increasing dosing schedule.

Usual Adult Kisunla dose is every 4 weeks:

• Infusion 1: 350mg
• Infusion 2: 700mg
• Infusion 3: 1,050 mg
• Infusion 4 and beyond: 1,400 mg

Comments

• Kisunla is given every four weeks as an intravenous infusion over approximately 30 minutes; it must be diluted prior to administration.
• Consider stopping dosing with Kisunla based on the reduction of amyloid plaques to minimal levels on amyloid PET imaging.
• If an infusion is missed, resume administration every 4 weeks at the same dose as soon as possible.

Dose modifications may be required for patients with ARIA-E and ARIA-H

Kisunla is available as: 350 mg/20 mL (17.5 mg/mL) in a single-dose vial.

Other drugs may interact with Kisunla, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

HCPs and patients often use the Kisunla Package Insert (PI) brand for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Kisunla Prescribing Information (PI) or FDA label.

Unopened Vial

Store refrigerated at 2°C to 8°C (36°F to 46°F).

Keep the vial in the outer carton to protect it from light.

Do not freeze or shake.

If refrigeration is not available, it may be stored at room temperature (20°C to 25°C [68°F to 77°F]) for up to 3 days.

Diluted Solution

After dilution, immediate use is recommended.

Diluted solution may be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 72 hours or at room temperature (20°C to 25°C [68°F to 77°F]) for up to 12 hours.

Do not freeze the diluted solution.

Storage times include the duration of infusion.

Active ingredient: donanemab-azbt

Inactive ingredients: anhydrous citric acid, polysorbate 80, sodium citrate, sucrose, and Water for Injection, USP.

Eli Lilly and Company, Indianapolis, IN 46285, USA