Kisunla (Donanemab)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Kisunla Used For?
Kisunla contains donanemab, a monoclonal antibody designed to treat early-stage Alzheimer’s disease. It’s specifically for patients who either carry one copy of the ApoE ε4 gene or don’t carry this gene at all.
Primary Uses
Kisunla treats the early stages of Alzheimer’s disease in patients who carry one copy of the apolipoprotein E4 gene (ApoE ε4 heterozygotes) or in those who do not carry this gene. Before starting treatment, your doctor will confirm you have beta-amyloid protein in your brain through testing.
How It Works
Kisunla is a monoclonal antibody that works by removing beta-amyloid protein from the brain. This protein is believed to cause Alzheimer’s disease to advance. The medicine specifically recognizes and binds to these harmful protein clumps to help clear them from your brain.
Good to know: Your doctor will perform genetic testing before treatment to ensure Kisunla is safe for you, and will confirm the presence of beta-amyloid protein through brain testing.
How to Take Kisunla
Kisunla is given as an intravenous infusion through a drip in your arm at a specialized medical center. The treatment is administered by healthcare professionals over approximately 30 minutes.
Dosage Instructions
Treatment starts with 350 mg for the first dose, 700 mg for the second dose, 1050 mg for the third dose, then 1400 mg every 4 weeks thereafter. Treatment continues for a maximum of 18 months. Your doctor will monitor you for 30 minutes after each infusion and may adjust your dose or stop treatment based on your response.
What If You Miss a Dose?
If a dose is missed, your healthcare professional will give you the missed dose at the next possible opportunity. Regular dosing every 4 weeks will then resume as scheduled.
Important: You’ll need regular brain MRI scans before your second, third, fourth, and seventh doses to monitor for side effects, particularly ARIA (brain swelling or bleeding).
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Headache
- Nausea and vomiting
- Feeling weak or tired
- Falls
- Weight loss
- Muscle aches
- Pain in arms or legs
- Dizziness
- Feeling faint
- Mild infusion-related reactions (flushing, chills, chest tightness)
- Cold-like symptoms
- Depression
- Trouble sleeping
- Enlarged prostate (in men)
Seek immediate medical attention if you experience:
- ARIA (brain swelling or bleeding) – headache, confusion, vomiting, loss of balance, vision changes, speech problems, loss of consciousness, seizures
- Anaphylactic reaction – difficulty breathing, face/throat swelling, fast heartbeat, loss of consciousness
- Brain bleeds – sudden weakness, numbness on one side, temporary vision loss
- Superficial siderosis – hearing loss, loss of muscle control
Important Warnings
Kisunla carries serious warnings, particularly about brain swelling and bleeding (ARIA), which can be life-threatening. Genetic testing is required before treatment.
Who Should Not Take Kisunla
Do not use Kisunla if you: have an allergy to donanemab or any ingredients; previously had bleeding or swelling in the brain; have severe white matter disease; or carry two copies of the ApoE ε4 gene (homozygotes), as this significantly increases the risk of serious brain side effects.
Medical Conditions to Discuss
Tell your doctor if you: take blood-thinning medicines (including aspirin); are on a low salt diet (each dose contains 2% of daily recommended sodium); have cerebral amyloid angiopathy (a condition affecting brain blood vessels); or have any other medical conditions.
Pregnancy and Breastfeeding
Kisunla is not recommended during pregnancy as its effects on pregnant women are unknown. Talk to your doctor if you are breastfeeding or plan to breastfeed. The medicine should not be used in children and adolescents under 18 years as Alzheimer’s disease does not occur in this age group.
ARIA Warning: Monoclonal antibodies like Kisunla can cause serious brain swelling (ARIA-E) or bleeding (ARIA-H) that can be life-threatening. This risk is higher in patients with two copies of the ApoE ε4 gene, which is why genetic testing is required before treatment.
Drug Interactions
Some medicines may interfere with Kisunla and affect how it works. It’s especially important to discuss blood-thinning medications with your doctor.
Blood thinners: Tell your doctor about any medicines that reduce blood clots, as treatment to dissolve blood clots should be carefully considered if you develop ARIA symptoms that look like a stroke.
- Blood clot reducing medicines (antithrombotic medicines)
- Aspirin (acetylsalicylic acid)
- Other prescription medicines
- Vitamins and supplements
Alcohol & Driving
Be cautious with activities requiring alertness until you know how Kisunla affects you.
Alcohol
No specific alcohol warnings are mentioned in the prescribing information. However, discuss alcohol use with your doctor, especially if you’re taking other medications.
Driving and Operating Machinery
Be careful before you drive or use any machines or tools until you know how Kisunla affects you. The medication can cause dizziness, confusion, and other symptoms that may impair your ability to drive safely.
Storage
Kisunla will be stored and handled by your healthcare professionals. They will keep it refrigerated between 2°C to 8°C until use and check the expiry date before administration. Any unused medicine will be safely disposed of by the healthcare facility.
Overdose Information
Since Kisunla is given by healthcare professionals in a controlled setting, overdose is unlikely. However, if you think you’ve been given too much, seek immediate medical attention. Contact the Poisons Information Centre at 13 11 26, your doctor, or go to the nearest hospital emergency department, even if you feel fine.
Frequently Asked Questions
Kisunla treatment continues for a maximum of 18 months, with infusions given every 4 weeks after the initial three escalating doses.
Genetic testing checks for the ApoE ε4 gene. Patients with two copies of this gene cannot use Kisunla due to significantly increased risk of serious brain side effects called ARIA.
ARIA (Amyloid Related Imaging Abnormalities) is brain swelling or bleeding that can occur with Kisunla. While often without symptoms, it can be serious or life-threatening. Regular MRI scans monitor for this side effect.
Each infusion takes approximately 30 minutes, followed by 30 minutes of monitoring for infusion-related reactions, so plan for about an hour at the medical center.
Tell your doctor about all medications, especially blood thinners like aspirin. Some medicines may interact with Kisunla, so your doctor needs to review all your medications before treatment.
Contact your doctor immediately if you have headache, confusion, vomiting, vision changes, or speech problems, as these could be signs of ARIA, a serious brain-related side effect.
Yes, you’ll need MRI scans before your second, third, fourth, and seventh doses to monitor for ARIA and other potential brain-related side effects.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.