Aduhelm (Aducanumab)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Product Details
Description
Aduhelm, known by the generic name aducanumab, is a medication used to treat Alzheimer's disease. Classified as a monoclonal antibody, it works by binding to amyloid beta plaques—a hallmark of Alzheimer's—to help clear them from the brain. Aduhelm comes as an injection and is typically recommended for early stage Alzheimer's. As a result, it may help slow down the cognitive decline associated with the disease.
Directions
Aduhelm is typically started at a dosage of 1 mg/kg over approximately one hour every four weeks.The dosage is then gradually increased to a maintenance dosage of 10 mg/kg infusion. It is recommended to receive monitoring during the infusion and for at least one hour afterward for any immediate reactions.
When beginning Aduhelm therapy, additional tests are needed, including an MRI, to ensure it's safe to use the medication. Healthcare professionals also do regular monitoring of MRI results throughout the treatment period to track any changes. Amyloid beta plaques must be confirmed to be present before starting treatment.
Ingredients
Aduhelm contains the active ingredient aducanumab. Along with the active substance, the formulation may include several inactive ingredients that help stabilize the solution and boost its delivery. The inactive ingredients may include polysorbate 80, water for injection, and others.
Contraindications
There are no known contraindications for Aduhelm indicated on the drug label.
Cautions
- Before starting Aduhelm, patients should inform their doctor about:
- Any allergies to medications, especially other monoclonal antibodies.
- Existing medical conditions.
- Current medications, as interactions can affect how Aduhelm works or increase side effect risks.
- If they are pregnant, planning to become pregnant, or breastfeeding, as it is not clear if Aduhelm can harm an unborn baby or pass into breast milk.
- Aduhelm may cause amyloid related imaging abnormalities (ARIA). These are usually asymptomatic but can sometimes lead to serious or life-threatening events, including significant bleeding in the brain or intracerebral hemorrhage.
- If you carry two copies of the ApoE e4 gene (homozygotes), you may have a higher risk of developing ARIA, including serious symptoms, compared to those with one copy (heterozygotes) or no copies of the gene. Discuss genetic testing for ApoE e4 status with your doctor to understand your risk before starting treatment. Weigh the benefits of Aduhelm in treating Alzheimer's disease against the potential risks of ARIA.
- Increased monitoring for ARIA is recommended during the first eight doses of Aduhelm, especially during dosage increases. Individuals with two copies of the ApoE e4 gene face a higher risk of symptomatic ARIA. If you experience symptoms suggestive of ARIA, seek immediate medical evaluation, including an MRI if necessary.
- Hypersensitivity reactions, like swelling or itching, may occur with Aduhelm. If you experience a hypersensitivity reaction, stop the treatment immediately and seek appropriate medical care.
Side Effects
Treatment with Aduhelm may lead to several side effects, though not everyone experiences them. The most common Aduhelm side effects involve brain-related changes, known as amyloid-related imaging abnormalities. These typically do not cause noticeable symptoms but can be detected through MRI scans. Some people may experience headaches, dizziness, confusion, nausea, or vision changes. Seek immediate medical attention if these side effects develop.
References:
- Aduhelm (Aducanumab) Product Monograph. Cambridge, MA: Biogen Inc; 2023.
- Aduhelm (Aducanumab) Drug Label Information. Cambridge, MA: Biogen Inc; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14421
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