Kisunla Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Kisunla Injection (donanemab) is a prescription medicine given by IV infusion to treat Alzheimer's disease in adults with mild cognitive impairment or mild dementia caused by the disease. It belongs to the amyloid beta-directed antibody class and works by targeting and helping clear amyloid plaques in the brain. It is given once every 4 weeks as an infusion, with the dose increased slowly at first to reduce the risk of side effects.

What is Kisunla Injection

Kisunla is a prescription medicine given by IV infusion to treat Alzheimer's disease in adults with mild cognitive impairment or mild dementia caused by the disease. It targets and helps clear amyloid plaques in the brain, which are linked to Alzheimer's symptoms. Its generic name is donanemab, and it belongs to the miscellaneous central nervous system agents class, specifically amyloid beta-directed antibodies.

Kisunla Injection uses

• Slows the progression of Alzheimer's disease
• Helps slow decline in memory
• Helps slow decline in thinking abilities
• May help maintain daily functioning
• Targets amyloid plaques in the brain

Benefits of Kisunla Injection

• Helps slow the decline in memory, thinking, and daily functioning
• Slows the progression of Alzheimer's disease, allowing people to keep doing daily activities and hobbies longer
• Significantly slowed Alzheimer's disease progression by more than 20% at 76 weeks in a clinical trial measured by iADRS and CDR-SB scores
• Reduces amyloid beta plaques in the brain

How Kisunla Injection works

Alzheimer's symptoms are linked to clumps of amyloid protein (amyloid plaques) in the brain. Kisunla is an antibody that attaches to these plaques and helps the brain's immune cells clear them away, which reduces plaque levels and slows the disease.

Kisunla Injection dosage

Kisunla is given by a healthcare provider as an infusion into a vein (IV), with each infusion lasting about 30 minutes. It is given once every 4 weeks, with the dose increased slowly over the first several infusions to lower the risk of side effects. If a dose is missed, the next infusion should be given as soon as possible, then continuing on the usual every-4-week schedule.

Before starting treatment, a doctor will confirm amyloid plaques are present and get a baseline brain MRI scan. Additional MRI scans are done before certain later infusions to check for brain swelling or bleeding (ARIA). Patients should be observed for at least 30 minutes after the infusion to check for reactions. Treatment may be stopped based on a doctor's judgment once brain scans show amyloid plaques have dropped to low levels.

Available forms and strengths

Kisunla is available as an injection.

Side effects of Kisunla Injection

Common

• Early Alzheimer's disease
• Mild cognitive impairment
• Mild dementia due to Alzheimer's disease

Serious

• Serious allergic reactions (swelling of the face, lips, mouth, or eyelids, difficulty breathing, hives)
• Infusion-related reactions (sweating, skin irritation, headache, nausea, chest pain, vomiting, problems breathing, chills)
• Amyloid related imaging abnormalities (ARIA) including brain swelling and bleeding, which can be fatal
• Intestinal obstruction
• Intestinal perforation
• Intracerebral hemorrhage greater than 1 cm in diameter

Warnings and precautions

• Kisunla can cause amyloid related imaging abnormalities (ARIA), swelling and sometimes bleeding in the brain. ARIA is usually seen on MRI scans and often has no symptoms, but serious and life-threatening problems can occur, and ARIA can be fatal.
• People with two copies of a certain gene (ApoE ε4 homozygotes) have a higher chance of getting ARIA, including serious ARIA. Genetic testing can be done before starting treatment to learn this risk.
• Taking blood-thinning medicines while on Kisunla may raise the risk of bleeding in the brain.
• Do not take Kisunla if you have had a serious allergic reaction to donanemab-azbt or any of its ingredients.
• Serious allergic reactions, including anaphylaxis and swelling of the face, lips, mouth, or eyelids, can happen during or after an infusion.
• Tell your doctor if you are pregnant, plan to become pregnant, or become pregnant during treatment, since it isn't known if this medicine could harm an unborn baby.
• Tell your doctor if you are breastfeeding or plan to, since it isn't known if the medicine passes into breast milk. Talk with your doctor about the best way to feed your baby during treatment.
• Inform your doctor about any history of brain bleeding.
• Brain MRI scans are required to monitor for swelling or bleeding.
• Talk with your doctor about alcohol use before starting this medicine.
• Report severe headache, confusion, dizziness, or vision changes immediately.

Storage

• 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
• 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

When to see a doctor

• Call your healthcare provider or go to the nearest emergency room right away if you have symptoms of ARIA, such as headache, dizziness, nausea, trouble walking, confusion, vision changes, or seizures.
• Tell your healthcare provider right away if you have signs of a serious allergic reaction, such as swelling of the face, lips, mouth, or eyelids, trouble breathing, or hives, during or after your infusion.
• Tell your healthcare provider right away if you have symptoms like sweating, skin irritation, headache, nausea, chest pain, vomiting, chills, or trouble breathing during an infusion, since this could be an infusion reaction.

Alternatives

• Aduhelm (Aducanumab)
• Leqembi (Lecanemab)