Pronunciation:

a-due-KAN-ue-mab - avwa

Brand Names:

• Aduhelm

Warnings:

Warning: Amyloid Related Imaging AbnormalitiesMonoclonal antibodies directed against aggregated forms of beta amyloid, including aducanumab-avwa, 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, some of which have been fatal, have been observed in patients treated with class of medications.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 aducanumab-avwa, 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 aducanumab-avwa; however, it cannot be determined if they are ApoE e4 homozygotes and at higher risk for ARIA.Consider the benefit of aducanumab-avwa for the treatment of Alzheimer's disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with aducanumab-avwa .

Classifications:

Pharmacologic—

Aducanumab

Uses of This Medicine:

Aducanumab-avwa 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 aducanumab-avwa 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 aducanumab-avwa injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 1 hour. This medicine is usually given every 4 weeks at least 21 days apart.

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.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

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 angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have hives, welts, or itching, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, or redness of the skin.

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

Blurred or changes in vision

confusion

confusion as to time, place, or person

dizziness

falls

hallucinations

headache

holding false beliefs that cannot be changed by fact

mental depression or anxiety

nausea

nightmares or unusually vivid dreams

problems with movement, walking, or speech

seizures

sleepiness or unusual drowsiness

unusual excitement, nervousness, or restlessness

vomiting

Incidence not known

Hives, welts, or itching

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

redness of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

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.