RITUXAN
Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of several B-cell malignancies and autoimmune disorders in adult and pediatric patients. It is used to treat various forms of Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia, frequently in combination with chemotherapy regimens. Additionally, the drug is approved for chronic inflammatory conditions, including rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.
How RITUXAN Works
Rituximab is a monoclonal antibody designed to target the CD20 antigen, which is expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to this antigen, the drug mediates B-cell lysis through mechanisms such as complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity. In autoimmune conditions, depleting B-cells helps interrupt the inflammatory process by reducing autoantibody production, antigen presentation, and proinflammatory cytokine production.
Details
- Status
- Prescription
- First Approved
- 1997-11-26
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
RITUXAN Approval History
What RITUXAN Treats
6 indicationsRITUXAN is approved for 6 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Hodgkin's Lymphoma
- Diffuse Large B-Cell Lymphoma
- Burkitt Lymphoma
- Mature B-Cell Acute Leukemia
- Chronic Lymphocytic Leukemia
- Rheumatoid Arthritis
RITUXAN Boxed Warning
FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY 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 RITUXAN infusion; approximately 80% of fatal reactions occurred with first infusion. Monit...
WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY 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 RITUXAN infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RITUXAN infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions RITUXAN administration can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN 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 RITUXAN [see Warnings and Precautions (5.2) ] . Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with RITUXAN, 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 RITUXAN. Discontinue RITUXAN and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur
RITUXAN 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.
RITUXAN Biosimilars
3 FDA-approvedThese 3 alternatives require prescriber approval to substitute for RITUXAN.
What are biosimilars? Lower-cost alternatives to RITUXAN with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
RITUXAN 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 RITUXAN
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
RITUXAN FDA Label Details
ProIndications & Usage
FDA Label (PDF)RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) . Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. 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. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cycloph...
WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALO...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.