TRUXIMA (rituximab-abbs)
TRUXIMA is indicated for the treatment of Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Rheumatoid Arthritis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Pemphigus Vulgaris.
How TRUXIMA Works
Truxima is a monoclonal antibody designed to target the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to this antigen, the drug mediates B-cell lysis through mechanisms including complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity. In autoimmune settings like rheumatoid arthritis, the depletion of B-cells helps interrupt the inflammatory process by reducing autoantibody production and proinflammatory cytokine release. This targeted action allows for the reduction of B-cell populations involved in both malignancy and autoimmune-mediated tissue damage.
Details
- Status
- Prescription
- First Approved
- 2018-11-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TRUXIMA Approval History
What TRUXIMA Treats
6 indicationsTRUXIMA is approved for 6 conditions since its original approval in 2018. 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
TRUXIMA Boxed Warning
FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) 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 infusio...
WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) 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 TRUXIMA 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 Administration of rituximab products, including TRUXIMA, 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 TRUXIMA 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 TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation [ see Warnings and Precautions (5.3) ]. Progre
TRUXIMA 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.
TRUXIMA is a lower-cost alternative to Rituxan with no clinically meaningful differences. Requires prescriber approval to substitute.
TRUXIMA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TRUXIMA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRUXIMA treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05624554 | 1026-008 2022-501481-21-00, MK-1026-008 | Ph 3 | active not recruiting | A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008) |
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.
TRUXIMA FDA Label Details
Indications & Usage
FDA Label (PDF)TRUXIMA is indicated for the treatment of Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Rheumatoid Arthritis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Pemphigus Vulgaris.
WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENC...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.