Last reviewed 2026-04-20 · How we verify

Mabthera (rituximab)

Mabthera works by binding to the CD20 antigen on B-lymphocytes, triggering their destruction.

Mabthera (rituximab) is a CD20-directed cytolytic antibody developed by Genentech, targeting B-lymphocytes. It is a small molecule modality approved by the FDA in 1997 for various B-cell malignancies and autoimmune diseases. Mabthera is a patented product with a commercial status, and its key safety considerations include infusion reactions, neutropenia, and increased risk of infections. It works by binding to the CD20 antigen on B-lymphocytes, marking them for destruction. Mabthera is used to treat conditions such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis.

At a glance

Mechanism of action

Rituximab is monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab mediates B-cell lysis. Possible mechanisms of cell lysis include complement dependent cytotoxicity (CDC) and antibody dependent cell mediated cytotoxicity (ADCC). cells are believed to play role in the pathogenesis of rheumatoid arthritis (RA) and associated chronic synovitis. In this setting, cells may be acting at multiple sites in the autoimmune/inflammatory process, including through production of rheumatoid factor (RF) and other autoantibodies, antigen presentation, T-cell activation, and/or proinflammatory cytokine production.

Approved indications

• Burkitt cell leukemia
• Burkitt's lymphoma
• CD20 positive diffuse large B cell non Hodgkin's lymphoma
• Chronic lymphoid leukemia, disease
• Follicular lymphoma
• Granulomatosis with polyangiitis
• Microscopic polyangiitis
• Microscopic polyarteritis nodosa
• Neuromyelitis optica
• Non-Hodgkin's lymphoma
• Pemphigus foliaceus
• Pemphigus vulgaris
• Rheumatoid arthritis
• Systemic sclerosis
• Thrombotic thrombocytopenic purpura

Boxed warnings

• WARNING: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Severe mucocutaneous reactions, some with fatal outcomes ( 5.1 ). Hepatitis B virus reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.2 ). Progressive multifocal leukoencephalopathy resulting in death ( 5.3 ). Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA [see Warnings and Precautions (5.1) ]. Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab-containing products, including RITUXAN HYCELA, 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 HYCELA. Discontinue RITUXAN HYCELA and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.2) ] . Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ].

Common side effects

• Infusion-related reactions
• Fever
• Lymphopenia
• Chills
• Infection
• Asthenia
• Neutropenia
• Stomatitis
• Enteritis
• Sepsis
• Alanine aminotransferase increased
• Hypokalemia

Key clinical trials

• A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy (PHASE3)
• A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis (PHASE3)
• A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate (PHASE3)
• A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis (PHASE3)
• Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
• Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (PHASE2)
• A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) (PHASE2,PHASE3)
• Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia (PHASE1,PHASE2)

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:

• Mabthera CI brief — competitive landscape report
• Mabthera updates RSS · CI watch RSS
• Roche portfolio CI