Aduhelm 100 mg/mL intravenous solution

Generic name:
Aducanumab - injection

Pronunciation
(A-due-KAN-ue-mab)

Brand name(s)
Aduhelm

This medication may increase your risk of serious (possibly fatal) side effects such as temporary swelling of the brain, or small spots of bleeding in or on the surface of the brain. These side effects are also known as amyloid-related imaging abnormalities (ARIA). Your doctor may order a genetic test to measure your risk for ARIA before you start this medication. If the genetic test shows you are at greater risk, your doctor should discuss with you the risks and benefits of starting aducanumab. Your doctor will do magnetic resonance imaging (MRI) scans before and during treatment to check for these side effects. If you are also taking medications that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran), your doctor will monitor you more closely for bleeding. ARIA usually go away over time. They do not always cause symptoms, but tell your doctor right away if you develop symptoms such as headache, dizziness, nausea, confusion, seizures, trouble walking, or vision changes.

This medication is used to treat Alzheimer's disease. It is thought to work by decreasing a certain substance (amyloid beta) that builds up in the brain of people with Alzheimer's disease. Aducanumab belongs to a class of drugs known as monoclonal antibodies. This medication is not a cure for Alzheimer's disease. It may help slow down worsening of this disease and may delay disability.

Read the Medication Guide provided by your pharmacist before you start using aducanumab and each time you receive an injection. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually every 4 weeks. The injection is given by a health care professional, usually over 1 hour. The dosage is based on your medical condition, weight, and response to treatment. To reduce your risk of side effects, your doctor may start this medication at a low dose and gradually increase your dose.

Use this medication regularly to get the most benefit from it. To help you remember, it may help to mark your calendar with a reminder.

See also Warning section.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using aducanumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as genetic testing, MRI scans, cognitive assessment) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.