RUXIENCE
RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of several B-cell malignancies and autoimmune conditions in adult patients. It is used to treat specific forms of Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia, either as a single agent or in combination with chemotherapy. The drug is also approved for the management of moderately-to-severely-active rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.
How RUXIENCE Works
RUXIENCE is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, the drug mediates B-cell lysis through mechanisms including complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity. By depleting B-cells, the drug addresses the underlying causes of certain cancers and autoimmune processes, such as the production of autoantibodies and proinflammatory cytokines.
Details
- Status
- Prescription
- First Approved
- 2019-07-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
RUXIENCE Approval History
What RUXIENCE Treats
6 indicationsRUXIENCE is approved for 6 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Hodgkin's Lymphoma
- Chronic Lymphocytic Leukemia
- Rheumatoid Arthritis
- Granulomatosis with Polyangiitis
- Microscopic Polyangiitis
- Pemphigus Vulgaris
RUXIENCE Boxed Warning
FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RUXIENCE infusion for s...
WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RUXIENCE infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] . Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products [see Warnings and Precautions (5.2) ] . Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RUXIENCE. Discontinue RUXIENCE and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML) Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [see Warnings and Precautions (5.4) , Adverse Reactions (6.3) ] . WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. • Fatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RUXIENCE infusion for severe reactions ( 5.1 , 6.1 ). • Severe mucocutaneous reactions, some with fata
RUXIENCE Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
RUXIENCE is a lower-cost alternative to Rituxan with no clinically meaningful differences. Requires prescriber approval to substitute.
RUXIENCE Competitors
Pro10 other drugs also target CD20. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD20). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to RUXIENCE
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RUXIENCE FDA Label Details
ProIndications & Usage
FDA Label (PDF)RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: • Adult patients with Non-Hodgkin's Lymphoma (NHL) . o Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. o Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. o Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-lin...
WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 2...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.