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Aducanumab-Avwa

Warning

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.

Precautions

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.

Side Effects

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.