Patient information: uses, side effects, how to take - Kisunla

What is the most important information I should know about KISUNLA?

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 serious symptoms can occur. ARIA can be fatal. It is most commonly seen 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 get symptoms; however, some people may have symptoms such as:

headache
confusion

dizziness
vision changes

nausea
seizures

difficulty walking

Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor.

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

Your healthcare provider will do magnetic resonance imaging (MRI) scans before and during your treatment with KISUNLA 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.

Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries. For more information, go to www.kisunla.com or call 1-800-LillyRx (1-800-545-5979).

What is KISUNLA?

KISUNLA is a prescription medicine used to treat people with Alzheimer's disease.

It is not known if KISUNLA is safe and effective in children.

Do not receive KISUNLA if you:

have serious allergic reactions to donanemab-azbt or any of the ingredients in KISUNLA. See the end of this Medication Guide for a complete list of ingredients in KISUNLA.

Before receiving KISUNLA, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. It is not known if KISUNLA will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with KISUNLA.
are breastfeeding or plan to breastfeed. It is not known if donanemab-azbt (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 KISUNLA.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). Ask your healthcare provider for a list of these medications if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How will I receive KISUNLA?

KISUNLA is given by your healthcare provider through a needle placed in your vein (intravenous (IV) infusion) in your arm.
KISUNLA is given every 4 weeks. Each infusion will last about 30 minutes.
If you miss an infusion of KISUNLA, you should receive your next dose as soon as possible.

What are the possible side effects of KISUNLA?

KISUNLA can cause serious side effects, including:

See “What is the most important information I should know about KISUNLA?”
Serious allergic reactions. Swelling of the face, lips, mouth, or eyelids, difficulty breathing, and hives have happened during a KISUNLA infusion. Tell your healthcare provider if you have any symptoms of a serious allergic reaction during or after KISUNLA infusion.
Infusion-related reactions. Infusion-related reactions, which can be serious, have happened. If you have an infusion-related reaction, your infusion may be slowed down or stopped. Tell your healthcare provider right away if you get these symptoms during an infusion of KISUNLA:
chills
irritation of skin
nausea
vomiting
sweating
headache
chest pain
problems breathing

If you have ever had an infusion-related reaction while receiving KISUNLA, your healthcare provider may give you medicines before your KISUNLA infusions to decrease your chance of having an infusion reaction. These medicines may include an antihistamine, acetaminophen, or a steroid.

The most common side effects of KISUNLA include:

swelling in areas of the brain with or without small spots of bleeding in or on the surface of the brain (ARIA).
headache.

These are not all the possible side effects of KISUNLA. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of KISUNLA

Medicines are sometimes prescribed for purposes other than those listed in this Medication Guide. You can ask your pharmacist or healthcare provider for more information about KISUNLA that is written for health professionals.

What are the ingredients in KISUNLA?

Active ingredient: donanemab-azbt

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

KISUNLA is a trademark of Eli Lilly and Company.

For more information, go to www.kisunla.com or call 1-800-LillyRx (1-800-545-5979).

Eli Lilly and Company, Indianapolis, IN 46285, USA

US License No. 1891

KIS-0001-MG-20240702

Kisunla (Donanemab): Uses, Side Effects and Dosage