Kisunla Uses, Effects, Dosage, Interactions

What is Kisunla?

Kisunla, also known by its scientific name donanemab, is a medication specifically designed to treat Alzheimer’s disease. Its primary function is to help slow down the decline in memory, thinking, and daily activities. This means that individuals with Alzheimer’s can continue to engage in their everyday routines and hobbies for a longer period. Kisunla is administered once a month through an intravenous (IV) infusion.

How does Kisunla work?

The symptoms of Alzheimer’s disease are thought to be connected to clumps of amyloid protein, known as amyloid plaques, that build up in the brain. Kisunla works by targeting these plaques, assisting the body in removing them, which in turn slows the progression of Alzheimer’s disease.

FDA Approval and Use

The FDA approved Kisunla on July 2, 2024. It is intended for adults with early symptomatic Alzheimer’s disease, which includes those with mild cognitive impairment (MCI) and those in the mild dementia stage of Alzheimer’s. This approval is based on the presence of confirmed amyloid pathology. Kisunla is a product of Eli Lilly and Company.

Effectiveness of Kisunla

In clinical trials, particularly the TRAILBLAZER-ALZ 2 trial, Kisunla demonstrated a significant slowing of Alzheimer’s disease progression. Over a period of 76 weeks, the disease progression slowed by more than 20%. This was measured using the Integrated Alzheimer’s Disease Rating Scale (iADRS) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). The trial included patients with varying levels of tau protein, and the results showed that those in the earlier stages of the disease experienced the most significant benefits.

Common Side Effects of Kisunla

Kisunla can cause several side effects, the most common of which include headaches and swelling in areas of the brain. This swelling may occur with or without small spots of bleeding on the brain’s surface. These side effects were reported in at least 10% of patients and occurred more frequently than in those who received a placebo.

Serious Side Effects of Kisunla

– Allergic Reactions: Some patients may experience serious allergic reactions, including swelling of the face, lips, mouth, or eyelids, difficulty breathing, and hives. It is crucial to inform your healthcare provider immediately if you experience any of these symptoms.
– Infusion-related Reactions: Reactions during infusion can include sweating, skin irritation, headache, nausea, chest pain, vomiting, or breathing difficulties. If these symptoms occur, the infusion may need to be slowed or stopped. In such cases, your healthcare provider might pre-treat you with antihistamines, acetaminophen, or steroids to reduce the risk of these reactions.

This is not a complete list of side effects. It is important to consult your doctor for medical advice and report any side effects to the FDA at 1-800-FDA-1088.

Warnings of Kisunla

Kisunla can cause serious side effects, including Amyloid Related Imaging Abnormalities (ARIA), which can be fatal. ARIA is often seen as temporary swelling in the brain that usually resolves over time, and it may include small spots of bleeding. In some cases, larger areas of bleeding can occur.

– Symptoms of ARIA: Symptoms can include headache, dizziness, nausea, difficulty walking, confusion, vision changes, and seizures. It is critical to seek immediate medical attention if you experience any of these symptoms.
– Genetic Risk: Individuals with a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) are more susceptible to ARIA. Your healthcare provider may test for this gene.
– Blood Thinners: If you are taking medications to reduce blood clots, you may be at a higher risk of brain bleeding while on Kisunla.

MRI scans are performed before and during treatment to monitor for ARIA. It is advisable to carry information indicating that you are receiving Kisunla, as ARIA symptoms can mimic stroke symptoms. There are registries that collect information on Alzheimer’s treatments, and your healthcare provider can assist you in enrolling.

Who Should Not Take Kisunla?

You should not receive Kisunla if you have had serious allergic reactions to donanemab-azbt or any of its ingredients. Consult the complete ingredient list provided with the medication.

Before Taking Kisunla

– Pregnancy: Inform your healthcare provider if you are pregnant, planning to become pregnant, or become pregnant while taking Kisunla. The effects on an unborn baby are unknown.
– Breastfeeding: Notify your healthcare provider if you are breastfeeding or plan to breastfeed. It is unclear whether Kisunla passes into breast milk.

How Kisunla is Administered

Kisunla is given as an IV infusion in your arm, which takes about 30 minutes, every four weeks. If you miss a dose, you should receive your next infusion as soon as possible.

Dosage Information of Kisunla

– Usual Adult Dose: 700 mg every four weeks for the first three doses, then 1400 mg every four weeks.
– Administration: Kisunla is administered as an IV infusion over approximately 30 minutes. It must be diluted before administration. Treatment may be stopped based on amyloid plaque reduction observed in amyloid PET imaging. If an infusion is missed, resume the same dose every four weeks as soon as possible.

Interactions and Storage of Kisunla

– Interactions: Refer to the package insert for detailed interaction information.
– Storage:
– Unopened Vial: Store refrigerated at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light. Do not freeze or shake.
– Room Temperature: If refrigeration is unavailable, the vial may be stored at room temperature (20°C to 25°C [68°F to 77°F]) for up to three days.
– Diluted Solution: Use the diluted solution immediately if possible. It can be stored refrigerated for up to 72 hours or at room temperature for up to 12 hours. Do not freeze the diluted solution.

Ingredients of Kisunla

– Active Ingredient: donanemab-azbt
– Inactive Ingredients: Anhydrous citric acid, polysorbate 80, sodium citrate, sucrose, and Water for Injection, USP.

Manufacturer of Kisunla

Kisunla is manufactured by Eli Lilly and Company, located in Indianapolis, IN 46285, USA.

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