Last reviewed 2026-05-28 · How we verify

TRUXIMA (RITUXIMAB-ABBS)

TRUXIMA (generic name: RITUXIMAB-ABBS) is a CD20-directed Cytolytic Antibody [EPC] drug developed by CELLTRION INC. It is currently FDA-approved.

TRUXIMA is a binding agent that targets the B-lymphocyte antigen CD20. It is used to treat various types of lymphoma, including Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System, Monomorphic B-Cell Post-Transplant Lymphoproliferative Disorder, Polymorphic Post-Transplant Lymphoproliferative Disorder, Recurrent Diffuse Large B-Cell Lymphoma, and Recurrent Follicular Lymphoma.

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• 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) ]. Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [ see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ].

Common side effects

• Infusion-related reactions
• Infection
• Lymphopenia
• Fever
• Chills
• Asthenia
• Neutropenia
• Nausea
• Vomiting
• Pruritus
• Rash
• Urticaria

Serious adverse events

• Sepsis
• Grade 3-4 Infusion-related reactions
• Serious infections (Grade 3-4)
• Fungal infections
• Viral infections
• Bacterial infections

Key clinical trials

• A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patie (Phase 3)
• Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Ibrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone Followed by Ibrutinib Maintenance in Patients Wit (Phase 2)
• Prospective Study of Incidence and Risk Factors of Infections and of Replacement Therapy With Intravenous Immunoglobulins for Secondary Immunodeficiency in Patients With Autoimmune Diseases Treated Wi (N/A)
• Safety and Efficacy of Zanubrutinib in Combination With Rituximab and Venetoclax in Previously Untreated Follicular Lymphoma: An Open Label, Phase 2 Study (Phase 2)
• A Prospective, Sequential Study to Assess the Efficacy of Rituximab Therapy in Maintaining Remission of Nephrotic Syndrome After Steroid and Immunosuppressive Therapy Withdrawal in Patients With Stero (Phase 3)
• The Efficacy and Safety of Zanubrutinib, Lenalidomide and Rituximab (ZR2) Regimen in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL) (Phase 2)
• Haploidentical Hematopoietic Stem Cell Transplantation Using A Novel Clofarabine Containing Conditioning Regimen For Patients With Refractory Hematologic Malignancies (Phase 1)
• Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy (Phase 3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• TRUXIMA CI brief — competitive landscape report
• TRUXIMA updates RSS · CI watch RSS
• CELLTRION INC portfolio CI

Frequently asked questions about TRUXIMA

Related

• Drug class: All CD20-directed Cytolytic Antibody [EPC] drugs
• Manufacturer: CELLTRION INC — full pipeline
• Therapeutic area: All drugs in Other

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing