Aducanumab is used to treat adults with Alzheimer's disease.

Aducanumab may also be used for purposes not listed in this medication guide.

Aducanumab can cause temporary swelling or bleeding in the brain that usually clears up with time. This may cause no symptoms but can be serious. Call your doctor if you have headaches, dizziness, nausea, confusion, or vision changes.

Aducanumab is injected into a vein by a healthcare provider.

This medicine is injected slowly over 1 hour.

Aducanumab is usually given every 4 weeks, at least 21 days apart.

You will need brain MRIs while receiving aducanumab.

Usual Adult Dose for Alzheimer's Disease:

Titration is required for treatment initiation: Doses are infused over 1 hour every 4 weeks:
-Infusion 1 and 2: 1 mg/kg IV
-Infusion 3 and 4: 3 mg/kg IV
-Infusion 5 and 6: 6 mg/kg IV
Maintenance dose: 10 mg/kg IV once every 4 weeks

Comments:
-Administer via IV infusion approximately every 4 weeks and at least 21 days apart.
-Study patients in the clinical trials had mild cognitive impairment or mild dementia stage of disease; there are no safety or
effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
-This drug has been approved under an accelerated approval based on reduction in amyloid beta plaques observed in patients treated in clinical studies; continued approval may be contingent upon verification of clinical benefit in confirmatory trials.

Use: For the treatment of Alzheimer's disease in patients with mild cognitive impairment or mild dementia stage of disease.

Aducanumab can cause a condition called Amyloid Related Imaging Abnormalities or "ARIA."

ARIA is a temporary swelling or small spots of bleeding in the brain that usually clears up with time. Your doctor may perform an MRI of your brain before and during your treatment with aducanumab. Ask your doctor about your risk.

It is not known if aducanumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using aducanumab.

Call your doctor for instructions if you miss an appointment for your aducanumab injection.

In a medical setting an overdose would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Aducanumab can cause temporary swelling or bleeding in the brain. Call your doctor if you have:

• dizziness, confusion;

• trouble walking;

• seizures;

• nausea; or

• vision changes.

Common side effects of aducanumab may include:

• ARIA with symptoms, or with signs that appear on an MRI;

• headache; or

• falls.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially medicines to treat or prevent blood clots, including aspirin.

Other drugs may affect aducanumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.