Aduhelm injection is used to reduce amyloid beta plaque, a protein found in the brain of people with Alzheimer's disease (a brain disease that slowly destroys the memory and ability to think, learn, communicate and handle daily activities).

Aduhelm is used to treat people with Alzheimer’s disease who have mild cognitive impairment (MCI) or mild dementia.

Aduhelm injection belongs to a class of medications called monoclonal antibodies. It works by blocking the formation of amyloid beta in the brain.

Aduhelm 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.

To make sure Aduhelm is safe for you, tell your doctor if you:

• have ever had an allergic reaction to aducanumab, any other medications, or any of the ingredients in Aduhelm injection.
• take any other prescription or nonprescription medications, vitamins, nutritional supplements, and herbal products. Your doctor may need to change the doses of your medications or monitor you carefully for side effects; or
• have or have ever had any medical conditions.

Before taking this medicine

Aduhelm 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 Aduhelm. 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 this medicine.

Aduhelm injection comes as a solution (liquid) and is injected into a vein by a doctor or nurse in a hospital or clinic. It is usually given slowly over one hour, once every 4 weeks (at least 21 days apart).

You will need brain MRIs while receiving Aduhelm.

Your doctor may need to interrupt your treatment or stop your treatment depending on your response to the medication and any side effects that you experience. Be sure to tell your doctor how you are feeling during your treatment.

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.

Aduhelm 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 Aduhelm. 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 this medicine.

Call your doctor for instructions if you miss an appointment for your Aduhelm 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 to Aduhelm: 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.

Aduhelm 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 Aduhelm side effects 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 interact with aducanumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.