Aducanumab-avwa (Intravenous)

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.

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.

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.

Pediatric

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.

Geriatric

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

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.

In the U.S.

• Aduhelm

Available Dosage Forms:

• Solution

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Aducanumab

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.

• What drugs can help improve or slow down memory loss?