FDA approval controversy

There has been considerable controversy surrounding Aduhelm since the Food and Drug Administration (FDA) granted the drug accelerated approval in 2021.

The accelerated approval of Aduhelm has been controversial for several reasons, and the issue is ongoing. For more information, see this article.

Aduhelm (aducanumab-avwa) is a brand-name drug that’s prescribed for Alzheimer’s disease in some adults. Aduhelm comes as a liquid solution that’s given as an intravenous (IV) infusion by a healthcare professional.

Aduhelm is approved by the Food and Drug Administration (FDA) to treat early-stage Alzheimer’s disease. Early stage includes adults who have mild cognitive impairment or mild dementia.

Aduhelm is a biologic and belongs to a drug class called monoclonal antibodies. Aduhelm is not available in a biosimilar version.

Keep reading for specific information about the dosage of Aduhelm, including its strength and how you’ll receive the medication. For a comprehensive look at Aduhelm, see this article.

Note: This article describes typical dosages for Aduhelm provided by the drug’s manufacturer. However, your doctor will prescribe the Aduhelm dosage that’s right for you.

Read below for recommended dosages of Aduhelm and other details about the drug.

Aduhelm form

Aduhelm comes as a solution that’s given as an IV infusion. It’s always given by a healthcare professional.

Aduhelm strength

Aduhelm comes in one strength of 100 milligrams per milliliter of solution (mg/mL).

Typical dosages

Typically, your doctor will start you on a low dosage infusion based on your body weight. Then, they’ll increase it over time until the recommended dosage is reached.

Before starting Aduhelm, your doctor will likely have you complete an MRI scan. Your doctor may also have you complete additional MRI scans during your Aduhelm treatment to monitor for amyloid-related imaging abnormalities (ARIA) and to assess whether Aduhelm is helping your Alzheimer’s disease.

The following information describes dosages that are commonly used in adults. Your doctor will determine the best dosage to fit your needs.

Dosage for Alzheimer’s disease

Doctors may prescribe Aduhelm to treat Alzheimer’s disease.

Aduhelm dosage is based on your body weight in kilograms (kg). One kg equals about 2.2 pounds (lb). The dosage per kg is measured in milligrams per kilogram (mg/kg) and is calculated by your doctor.

For Alzheimer’s disease, your starting dose will likely be 1 mg/kg of body weight. Typically, you’ll receive this once every 4 weeks for your first two infusions. For infusions three and four, your doctor will likely increase your dosage to 3 mg/kg of body weight given every 4 weeks. Then, you’ll likely have another dose increase to 6 mg/kg at infusions five and six.

For infusion seven and beyond, you’ll receive a dosage of 10 mg/kg. You’ll continue to receive this dose every 4 weeks. This is the typical maintenance dosage for people receiving Aduhelm. This is also the maximum dose of Aduhelm that’s recommended.

The table below shows the typical dosage schedule, including the starting titration dosage schedule and maintenance dosage. Your doctor will choose a dose and schedule that suits your needs.

Dosing schedule for a 70-kg (about 154 lb) adult starting Aduhelm treatment:

Infusion session (Aduhelm is typically infused every 4 weeks)DosageDosage example for a 70-kg (about 154 lb) adult
infusions 1 and 21 mg/kg70 mg
infusions 3 and 43 mg/kg210 mg
infusions 5 and 66 mg/kg420 mg
infusion 7 and each infusion thereafter (maintenance doses)10 mg/kg700 mg

For more information about your specific dosage, talk with your doctor.

Long-term treatment

Aduhelm is meant to be used as a long-term treatment. If you and your doctor determine that Aduhelm is safe and effective for you, you’ll likely receive it long term.

Before starting treatment with Aduhelm, your doctor will discuss your treatment plan with you.

The Aduhelm dosage your doctor prescribes will depend on several factors. These include:

  • your body weight
  • how your body responds to Aduhelm
  • side effects you may have with Aduhelm

Other medical conditions you have can also affect your Aduhelm dosage.

Your doctor or another healthcare professional will give you the IV infusion of Aduhelm. First, they’ll prepare the liquid solution for infusion. You’ll likely go to your doctor’s office, infusion center, or a hospital to receive your infusion. The infusion takes about 1 hour.

If you have questions about how to use Aduhelm, talk with your doctor or pharmacist. There’s also information about getting started on Aduhelm on the manufacturer’s website.

ACCESSIBLE DRUG LABELS AND CONTAINERS

Some pharmacies offer labels with large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist might be able to recommend a pharmacy that does.

If you’re having trouble opening medication bottles, ask your pharmacist about putting Aduhelm in an easy-open container. They also may recommend tools that can make it easier to open bottles.

If you miss your appointment for an Aduhelm infusion, call your doctor’s office as soon as possible to reschedule. They’ll adjust your dosing schedule as needed.

If you need help remembering your appointments, try setting an alarm or downloading a reminder app on your phone.

Below are some frequently asked questions about Aduhelm.

How long does it take for Aduhelm to start working?

Aduhelm starts to work after your first dose. Because of how the drug works, you likely won’t feel the drug working in your body. But your doctor will monitor you during treatment to check whether the drug is working to treat your condition.

Talk with your doctor if you have questions about what to expect with Aduhelm treatment.

Is there a typical dosage range for Aduhelm?

Yes, depending on which infusion treatment session you are on and how your body is responding, the dosage for Aduhelm ranges anywhere from 1 milligram per kilogram (mg/kg) to 10 mg/kg.

The typical recommended dosage for Aduhelm during the maintenance phase of treatment is 10 mg/kg.

For more information about Aduhelm dosages, see the “Aduhelm dosage” section above. You can also talk with your doctor or pharmacist.

The dosages in this article are typical dosages provided by the drug’s manufacturer. If your doctor recommends Aduhelm for you, they will prescribe the dosage that’s right for you. Always follow the dosage that your doctor prescribes.

As with any drug, never change your dosage of Aduhelm without your doctor’s recommendation. If you have questions about the dosage of Aduhelm that’s best for you, talk with your doctor.

Besides learning about dosage, you may want other information about Aduhelm. These additional articles might be helpful:

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.