Ruxience

• Ruxience is a biosimilar to rituximab, targeting CD20-positive B-cells.
• It is approved for treating specific types of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and certain vasculitides.
• The medication works by binding to CD20 proteins on B-cells, leading to their destruction and reducing inflammation or tumor growth.
• Common side effects include infusion-related reactions, infections, and fatigue.
• Patients should be monitored for serious adverse events such as severe infections, progressive multifocal leukoencephalopathy (PML), and cardiac issues.

What is Ruxience and How It Works

Ruxience is a biologic medication, specifically a biosimilar to rituximab. It is a monoclonal antibody designed to target the CD20 protein found on the surface of B-lymphocytes, a type of white blood cell. By binding to CD20, Ruxience initiates a cascade of immune responses that lead to the destruction of these B-cells. This mechanism is crucial in treating conditions where an overabundance or dysfunction of B-cells contributes to disease progression, such as in certain lymphomas and autoimmune disorders.

The therapeutic action of Ruxience involves several pathways, including antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct induction of apoptosis (programmed cell death) in CD20-positive B-cells. This targeted approach helps to reduce the number of abnormal B-cells in cancer or modulate the immune system in autoimmune conditions. Understanding this mechanism is key to comprehending the broader Ruxience drug information and its clinical applications.

What is Ruxience Used For?

Ruxience is approved for the treatment of several conditions, primarily focusing on specific hematologic malignancies and autoimmune diseases. To answer what is Ruxience used for, its indications include:

• Non-Hodgkin’s Lymphoma (NHL): It is used in combination with chemotherapy for previously untreated or relapsed/refractory CD20-positive diffuse large B-cell, follicular, and low-grade or follicular CD20-positive B-cell non-Hodgkin’s lymphoma. NHL is a type of cancer that starts in white blood cells called lymphocytes, with an estimated 81,180 new cases in the U.S. in 2024, according to the American Cancer Society.
• Chronic Lymphocytic Leukemia (CLL): Ruxience is indicated in combination with fludarabine and cyclophosphamide for previously untreated and previously treated CD20-positive CLL. CLL is a slow-growing cancer of the blood and bone marrow, affecting approximately 20,160 new individuals in the U.S. annually.
• Rheumatoid Arthritis (RA): For adult patients with moderately to severely active RA who have had an inadequate response to one or more TNF inhibitor therapies, Ruxience can be used in combination with methotrexate. RA is a chronic inflammatory disorder affecting joints, impacting about 1.5 million Americans.
• Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): Ruxience is used in combination with glucocorticoids for adult patients with active GPA and MPA. These are rare, serious autoimmune diseases characterized by inflammation of small blood vessels.

The specific usage and dosage of Ruxience vary depending on the condition being treated and other factors, always determined by a healthcare professional.

Ruxience Side Effects and Warnings

Like all medications, Ruxience can cause side effects, ranging from mild to severe. Patients receiving this medication should be aware of potential Ruxience side effects and warnings and report any unusual symptoms to their healthcare provider promptly. The most common side effects often occur during or shortly after the infusion and include:

• Infusion-related reactions (e.g., fever, chills, nausea, rash, headache, dizziness)
• Infections (e.g., upper respiratory tract infections, urinary tract infections)
• Fatigue and weakness
• Nausea and diarrhea
• Headache
• Muscle spasms

More serious side effects and warnings associated with Ruxience include:

Severe Infusion Reactions: These can be life-threatening and may include angioedema, bronchospasm, hypotension, and anaphylaxis. Patients are closely monitored during and after infusions.

Serious Infections: Ruxience can increase the risk of severe bacterial, fungal, and viral infections, including reactivation of hepatitis B virus (HBV). Screening for HBV is typically performed before treatment initiation.

Progressive Multifocal Leukoencephalopathy (PML): This is a rare but very serious brain infection that can lead to severe disability or death. Symptoms may include changes in thinking, vision, strength, or balance.

Tumor Lysis Syndrome (TLS): This can occur in patients with certain cancers, particularly after the first infusion, due to the rapid breakdown of cancer cells. It can lead to kidney failure and heart problems.

Cardiac Toxicity: Patients with pre-existing cardiac conditions may be at increased risk of cardiac adverse events, including arrhythmia, angina, and heart failure.

It is crucial for patients to discuss their full medical history with their doctor before starting Ruxience, especially if they have a history of infections, heart conditions, or kidney problems. Regular monitoring and communication with the healthcare team are essential throughout the treatment period.