(doe nan′ e mab)

Brand Name(s): Kisunla^®

IMPORTANT WARNING:

Donanemab-azbt may cause a potentially serious reaction called amyloid related imaging abnormalities (ARIA), which most commonly includes temporary swelling in areas of the brain; small spots of bleeding on the surface of the brain and, infrequently, larger areas of bleeding in the brain may also occur. Swelling in areas of the brain usually does not cause symptoms and usually resolves over time. If you experience any of the following symptoms, tell your doctor immediately or get emergency medical treatment: headache, confusion, dizziness, vision changes, nausea, difficulty walking or loss of balance, or seizures.

The chance that you will develop ARIA during your treatment with donanemab-azbt may be higher if you have a genetic (inherited) risk factor. Your doctor may order a blood test to help decide if this medication is right for you. Tell your doctor if you are taking medications that may cause bleeding.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests such as magnetic resonance imaging (MRI; a medical test that uses powerful magnets to take pictures of the inside of the body) scans before and during treatment to check your body's response to donanemab-azbt.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with donanemab-azbt and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) {or the manufacturer's website} to obtain the Medication Guide.

WHY is this medicine prescribed?

Donanemab-azbt injection is used to treat early Alzheimer's disease. Donanemab-azbt is in a class of medications called monoclonal antibodies. It works by reducing amyloid beta plaques, abnormal proteins that develop in the brain and contribute to the progression of Alzheimer's disease.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Donanemab-azbt comes as a solution (liquid) to be give intravenously (into the vein) by a doctor or a nurse at a hospital or clinic. It is usually given over 30 minutes every 4 weeks.

Your doctor will probably start you on a low dose of donanemab-azbt for 3 doses and then increase your dose.

Donanemab-azbt injection may cause a severe reaction during or shortly after the infusion of the medication. A doctor or nurse will monitor you carefully while you are receiving the medication. You may be given other medications to help prevent and treat reactions. If you experience any of the following symptoms, tell your doctor immediately: fever, chills, body aches, joint pain, nausea, vomiting, dizziness or lightheadedness, feeling of racing heart rate or chest pounding, or difficulty breathing or shortness of breath.

Your doctor may need to interrupt your treatment or stop your treatment depending on your response to the medication and any side effects that you experience. Be sure to tell your doctor how you are feeling during your treatment.

Donanemab-azbt controls Alzheimer's disease but does not cure it. Do not stop receiving donanemab-azbt without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before receiving donanemab-azbt,

• tell your doctor and pharmacist if you are allergic to donanemab-azbt, any other medications, or any of the ingredients in donanemab-azbt injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking donanemab-azbt, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive donanemab-azbt injection, you should call your healthcare provider as soon as possible.

What SIDE EFFECTS can this medicine cause?

Donanemab-azbt may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• chills, redness of the skin, nausea, vomiting, difficulty breathing or shortness of breath, sweating, headache, chest pain, dizziness
• hives, rash, itching, swelling of the lips, tongue, or throat, shortness of breath or difficulty breathing

Donanemab-azbt may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 20, 2024.