ADUHELM 170 mg/1.7 ml Solution for Injection

What is ADUHELM 170 mg/1.7 ml

ADUHELM (generic name: Aducanumab) is a prescription medication formulated as a solution for injection. It is specifically designed for intravenous infusion and is presented in a single-dose glass vial containing 170 mg of Aducanumab in 1.7 ml solution. ADUHELM is primarily used in the treatment of Alzheimer’s disease, particularly targeting patients with mild cognitive impairment or mild dementia stage of the disease.

This medication represents a novel approach to Alzheimer’s treatment by aiming to reduce amyloid-beta plaques in the brain, which are believed to contribute to the progression of the disease. Aducanumab is a monoclonal antibody that selectively binds to aggregated forms of amyloid-beta, facilitating their clearance and potentially slowing cognitive decline.

Key points about ADUHELM include:

• Indication: Used for the treatment of Alzheimer’s disease at early stages.
• Formulation: Injectable solution for intravenous use only.
• Mechanism: Targets amyloid-beta plaques implicated in Alzheimer’s pathology.
• Administration: Administered by healthcare professionals under strict medical supervision.
• Innovative Therapy: One of the first disease-modifying therapies approved for Alzheimer’s.

How to use ADUHELM 170 mg/1.7 ml

ADUHELM must be administered strictly under medical supervision as an intravenous infusion. It is not a medication for self-administration and requires healthcare professionals trained in its handling and monitoring. Below are detailed instructions on how to use ADUHELM safely and effectively:

• Preparation: The single-dose vial should be inspected visually for particulate matter or discoloration before use. Use aseptic techniques to prepare the infusion.
• Administration: ADUHELM is given as a slow intravenous infusion, usually over a period determined by the prescribing physician, often around 1 hour.
• Frequency: The typical dosing schedule involves once-monthly infusions; however, the exact regimen will depend on patient-specific factors and physician guidance.
• Monitoring: Patients should be monitored during and after infusion for potential adverse reactions, including infusion-related reactions or signs of brain swelling (ARIA – amyloid-related imaging abnormalities).
• Imaging Requirements: Regular MRI scans may be required before and during treatment to monitor for ARIA.
• Patient Preparation: Patients and caregivers should be educated about the potential side effects and the importance of adherence to scheduled infusions.
• Storage and Handling: Vials must be stored under recommended conditions and only opened immediately prior to infusion to maintain medication integrity.

Mode of Action ADUHELM 170 mg/1.7 ml

ADUHELM (Aducanumab) functions as a human monoclonal antibody designed to selectively target aggregated amyloid-beta peptides in the brain. These aggregates form amyloid plaques, which are characteristic pathological hallmarks of Alzheimer’s disease. The drug's mode of action can be broken down as follows:

• Selective Binding: Aducanumab binds with high affinity to aggregated forms of amyloid-beta, including soluble oligomers and insoluble fibrils present in plaques.
• Immune-Mediated Clearance: After binding to amyloid aggregates, Aducanumab facilitates their clearance through activation of microglial cells, the brain's resident immune cells. This process promotes phagocytosis and removal of amyloid plaques.
• Reduction of Plaque Load: By decreasing the accumulation of amyloid plaques, Aducanumab aims to reduce neurotoxicity and neuronal damage associated with these deposits.
• Disease Modification: Unlike symptomatic treatments, ADUHELM targets a key pathological mechanism of Alzheimer’s disease, potentially slowing disease progression rather than just alleviating symptoms.
• Impact on Cognitive Decline: Clinical trials have suggested that reducing amyloid plaques correlates with a slowing of cognitive decline in certain patient populations.

Overall, ADUHELM represents a targeted immunotherapy approach that harnesses the body's immune system to tackle the underlying disease process in Alzheimer’s rather than only addressing symptoms.

ADUHELM 170 mg/1.7 ml Interactions ADUHELM 170 mg/1.7 ml

When considering the use of ADUHELM, understanding potential drug interactions is crucial for patient safety and therapeutic effectiveness. Though ADUHELM's interaction profile is not fully characterized due to its novel mechanism and biological nature, the following points are important:

• Immunosuppressants: Concomitant use of immunosuppressive agents may theoretically affect the efficacy or safety of ADUHELM, as it is an immune-mediated therapy.
• Anticoagulants and Antiplatelet Drugs: Patients on blood-thinning medications require careful monitoring since ADUHELM may increase the risk of cerebral microhemorrhages or brain swelling (ARIA).
• Other Alzheimer’s Medications: ADUHELM may be used alongside cholinesterase inhibitors or memantine, but no major direct interactions are known; monitoring for additive side effects is recommended.
• Vaccines or Biological Therapies: Caution is advised when combining with other monoclonal antibodies or biological agents, though specific interactions are not well-documented.
• General Considerations: Always inform healthcare providers of all medications, supplements, and herbal products to avoid unforeseen interactions or adverse effects.

Because ADUHELM is administered in a controlled clinical setting, the healthcare team will assess potential drug interactions based on the patient’s full medication profile to minimize risks.

Dosage of ADUHELM 170 mg/1.7 ml

The dosing of ADUHELM is carefully tailored to each patient and administered intravenously. The usual dose involves incremental titration to achieve an effective maintenance dose while monitoring for safety. Details include:

• Initial Dose: Treatment typically begins with a lower dose to assess tolerability, with gradual increases over subsequent infusions.
• Maintenance Dose: The target dose is generally 10 mg/kg body weight administered once every four weeks.
• Administration Schedule: ADUHELM is infused once monthly under medical supervision.
• Dose Adjustments: Adjustments or temporary suspension may be necessary if adverse effects such as ARIA occur.
• Treatment Duration: The duration depends on patient response and tolerability; ongoing assessment by a neurologist is critical.
• Special Populations: Dosing may require modification in patients with specific medical conditions; however, detailed data is limited.

Strict adherence to the prescribed dosing regimen and close monitoring is essential for achieving the best outcomes and minimizing risks associated with ADUHELM therapy.

Possible side effects of ADUHELM 170 mg/1.7 ml

ADUHELM, like many monoclonal antibody therapies, can cause side effects that range from mild to potentially serious. Patients receiving this medication must be closely monitored for adverse events. Common and significant side effects include:

• Amyloid-Related Imaging Abnormalities (ARIA): This includes brain edema (ARIA-E) and microhemorrhages (ARIA-H). These are the most serious side effects and require MRI monitoring.
• Infusion Reactions: Symptoms such as chills, fever, rash, flushing, headache, and nausea may occur during or after infusion.
• Headache and Dizziness: Patients may experience headaches or dizziness, often mild to moderate in severity.
• Falls and Injuries: Due to dizziness or cognitive impairment, there is an increased risk of falls.
• Other Neurological Symptoms: Confusion or worsening cognitive symptoms can occur in some cases.
• Allergic Reactions: Though rare, hypersensitivity reactions including rash, itching, or swelling may happen.

Because some side effects, especially ARIA, can be asymptomatic but serious, regular brain imaging and clinical assessments are critical during treatment. Prompt reporting of any new neurological symptoms to the healthcare provider is essential for timely management.

ADUHELM 170 mg/1.7 ml Contraindications ADUHELM 170 mg/1.7 ml

ADUHELM is contraindicated in patients with certain conditions or risk factors where the treatment's risks outweigh the potential benefits. Contraindications include:

• Known Hypersensitivity: Patients with a history of allergic or hypersensitivity reactions to Aducanumab or any components of ADUHELM should not receive this medication.
• Active Brain Hemorrhage or Significant Cerebral Microhemorrhages: Use is contraindicated in patients with active bleeding in the brain or extensive microbleeds due to increased risk of severe complications.
• Severe Brain Edema: Patients exhibiting significant brain swelling should not be treated until resolved.
• Uncontrolled Cardiovascular or Neurological Disorders: Conditions that could increase the risk of adverse events or interfere with treatment safety may serve as relative contraindications.
• Pregnancy and Lactation: Safety has not been established in pregnant or breastfeeding women, so use is generally avoided unless clearly necessary.

Each patient should be evaluated individually, and the decision to initiate ADUHELM therapy must be based on a thorough assessment of contraindications and potential risks.

Storage of ADUHELM 170 mg/1.7 ml

Proper storage of ADUHELM is essential to maintain its stability and effectiveness. The following storage guidelines should be observed:

• Temperature: Store the vials refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze the medication.
• Protection from Light: Keep the vials in the original carton to protect from light until the time of use.
• Handling: Handle vials carefully to avoid damage. Use aseptic techniques when preparing for infusion.
• Expiration: Check the expiration date on the vial; do not use expired medication.
• After Opening: Once opened, the solution should be used promptly. Any unused portions must be discarded as per medical guidelines.
• Transport: During transport, maintain cold chain conditions to ensure stability.

Following these storage instructions ensures that ADUHELM maintains its quality and therapeutic efficacy up to the point of administration.