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Aduhelm

Generic Name: Aducanumab (A-due-KANue-mab) A-due-KAN-ue-mab [ADUE –
Drug Class: Miscellaneous central nervous system agents

What is Aduhelm?

Aduhelm injections are used to decrease amyloid beta plaques, which are proteins found within the brains of individuals suffering from Alzheimer's disease (a neurodegenerative disease of the brain that gradually destroys memory and the ability to think and learn, as well as communicate and manage daily tasks).

Aduhelm is a treatment for patients with Alzheimer's disease who suffer from moderate cognitive impairment (MCI) or mild cognitive impairment.

Aduhelm injections are a class of drugs known as monoclonal antibodies. It is effective in preventing the creation of amyloid beta within the brain.

Warnings

Aduhelm can trigger some temporary swelling or bleeding in the brain, which is usually able to be cured over time. The condition may not cause any symptoms, but it could be severe. Contact your physician for nausea, headaches, dizziness, confusion, or a change in your vision.

To make sure that Aduhelm is safe for you, inform your doctor if you are:

  • If you have had any allergic reactions to the drug aducanumab or other medicines and/or any components in the Aduhelm injection,

  • You can also take other nonprescription or prescription medications, nutritional supplements, vitamins, or herbal supplements. Your physician may have to adjust the dosages of your medication or watch closely for any adverse effects.

  • Are currently suffering from or have suffered from any medical condition.

Before You Take This Drug

Aduhelm is a cause of a condition known as Amyloid Related Imaging Abnormalities, or "ARIA."

ARIA is an occasional swelling or tiny area of bleeding within the brain. It generally disappears over time. Your doctor might perform the MRI on your head prior to and during treatments with Aduhelm. Discuss with your doctor the potential risk.

It is unclear whether or not it will harm a baby who is not yet born. Consult your physician if you are expecting or planning to become pregnant.

Consult your doctor to determine whether it is safe to breastfeed while taking this medication.

How to Take Aduhelm?

Aduhelm injection is available as a liquid, which is administered into veins by a nurse or doctor in a clinic or hospital. It is usually administered slowly, over a period of one hour, every four weeks (at at least 21-day intervals).

You'll require brain MRIs when you receive Aduhelm.

Your doctor might have to stop or end your treatment based on the response you have to the medication as well as any adverse effects you encounter. Make sure you inform your doctor about what you're experiencing during treatment.

Details On Dosage

Usual Adult Dose for Alzheimer's Disease:

It is necessary to do a titration prior to treatment beginning. Doses are infused over 1 hour each week for 4 weeks:

Infusions 1 and 2: 1 mg/kg IV

Infusions 3 and 4: 3 mg/kg IV

Infusions 5 and 6: 6 mg/kg IV

Maintenance dose: 10 mg/kg IV once every 4 weeks

Comments:

Administration via IV infusions about every 4 weeks and at minimum 21-day intervals

Patients participating in the clinical trials suffered from moderate cognitive impairment, mild cognitive impairment,

or There are no risks or

Effectiveness data for initiating treatment at an earlier or later stage of disease were analyzed.

This drug was approved under an expedited approval process based on the reduction of amyloid beta plaques that were observed by patients in clinical trials; however, continuing approval could be contingent on evidence of clinical effectiveness through confirmatory studies.

Use: To treat Alzheimer's disease in patients with moderate cognitive impairment or mild dementia.

What Happens If I Miss a Dose?

Contact your doctor for advice. If you do not make an appointment to receive an appointment for an Aduhelm injection,

What Happens If I Overdose?

In a medical environment, an overdose could be immediately treated.

What Should Be Avoided?

Follow your doctor's advice regarding any restrictions regarding food, drinks, or any activity.

Side Effects Of Aduhelm

See a doctor immediately. If you are experiencing symptoms that you are experiencing an allergic reaction to Aduhelm, such as hives, breathing problems, or swelling of your lips, face, and tongue,

Certain side effects can occur when you inject. Contact your doctor if you are feeling faint, dizzy, nauseated, or sweaty. or if you experience a headache, chest tightness,

back

discomfort, breathing difficulties, or swelling on your face.

Aduhelm can trigger some temporary swelling or bleeding within the brain.

See your doctor if you are suffering from any of the following:

  • Dizziness, confusion;

  • Difficulty walking;

  • Seizures;

  • Nausea;

  • Vision shifts.

Common side effects of Aduhelm could include:

  • ARIA with symptoms or with signs that show to be present on MRI;

  • Headaches

  • Falls.

This isn't an exhaustive listing of all negative side consequences.

Other scenarios could occur.

Ask your doctor medical advice regarding adverse reactions.

If you have any concerns, report the allergic reactions or symptoms to FDA by calling 1-800-FDA-1088.

Interaction With Other Drugs

Inform your doctor about any other medications you take, particularly those to stop or treat blood clots, such as aspirin.

Other medications can be incompatible with the drug, such as prescription and over-the-counter medicines, vitamins, and herbal products. Discuss with your doctor all other medicines you take.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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