Donanemab-azbt injection may cause a serious or life-threatening reaction called amyloid related imaging abnormalities (ARIA; a condition that may cause swelling and bleeding in the brain). 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, muscle weakness, difficulty speaking, or seizures.
Always carry identification stating that you are receiving donanemab-azbt injection. If you need an identification card, ask your pharmacist or doctor how to get one.
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.
You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm 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 given intravenously (into the vein) by a doctor or a nurse at a hospital or clinic. It is given over 30 minutes every 4 weeks.
Your doctor will probably start you on a low dose of donanemab-azbt and gradually increase your dose.
Donanemab-azbt injection may cause serious reactions during or shortly after the infusion. A doctor or nurse will watch 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: chills, sweating, nausea, vomiting, redness or irritation of the skin, headache, chest pain, 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 injection,
- tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- the following nonprescription product may interact with donanemab-azbt injection: aspirin. Be sure to let your doctor and pharmacist know that you are taking this medication before you start receiving donanemab-azbt injection. Do not start this medication while receiving donanemab-azbt injection without discussing with your healthcare provider.
- 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 injection 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 or HOW sections, call your doctor immediately or get emergency medical treatment:
- 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?
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.