Pronunciation:

doe-NAN-e-mab - azbt

Brand Names:

• Kisunla

Dosage Forms:

• Solution

Warnings:

Warning: Amyloid Related Imaging AbnormalitiesMonoclonal antibodies directed against aggregated forms of beta amyloid, including donanemab-azbt, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur. Serious intracerebral hemorrhages greater than 1 cm, some of which have been fatal, have been observed in patients treated with this class of medications. Because ARIA-E can cause focal neurologic deficits that can mimic an ischemic stroke, treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with donanemab-azbt.ApoE e4 Homozygotes: Patients who are apolipoprotein E e4 (ApoE e4) homozygotes (approximately 15% of Alzheimer's disease patients) treated with this class of medications, including donanemab-azbt, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE e4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed they can still be treated with donanemab-azbt; however, it cannot be determined if they are ApoE e4 homozygotes and at higher risk for ARIA.Consider the benefit of donanemab-azbt for the treatment of Alzheimer's disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with donanemab-azbt .

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Donanemab

Uses of This Medicine:

Donanemab-azbt injection is used to treat Alzheimer's disease.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of donanemab-azbt injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of donanemab-azbt injection in the elderly.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 30 minutes. This medicine is usually given every 4 weeks.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Your doctor will do magnetic resonance imaging (MRI) scans before the first treatment, and at certain times during treatment with this medicine.

Your doctor may give you other medicines (eg, acetaminophen, allergy medicine, steroid medicine) before receiving this medicine to help prevent infusion-related reactions.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause amyloid related imaging abnormalities (ARIA), which can be seen as temporary swelling or bleeding in the brain. Call your doctor right away if you have changes in vision, confusion, dizziness, headache, nausea, or seizures.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a cough, difficulty swallowing, dizziness, fast heartbeat, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, rash, itching, trouble breathing, or unusual tiredness or weakness after receiving this medicine.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have back pain, blurred vision, chest tightness, chills, confusion, cough, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, drowsiness, fever, flushing, general feeling of discomfort or illness, headache, joint pain, muscle aches and pains, nausea and vomiting, nervousness, pale skin, pounding in the ears, runny nose, shivering, slow or fast heartbeat, sore throat, sweating, trouble breathing, trouble sleeping, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Back pain

chest pain or tightness

chills

confusion

fainting

fever

flushing, redness of the skin

headache

increased blood pressure

nausea and vomiting

pale skin

sweating

trouble breathing

unusually warm skin

weakness

Less common

Cough

difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Rare

Severe constipation

stomach pain

Incidence not known

Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.