Last reviewed 2026-04-20 · How we verify

Mabthera (Rituximab-Pvvr)

Monoclonal antibody targeting CD20 on B-lymphocytes, mediating cell lysis via CDC and ADCC.

Rituximab-pvvr is a CD20-directed monoclonal antibody indicated for NHL, CLL, RA, GPA/MPA, and pemphigus vulgaris in adult patients. It demonstrates robust clinical efficacy with half-lives ranging from 18-32 days depending on indication and disease state. Key safety considerations include potential renal toxicity with cisplatin co-administration and variable clearance based on disease burden and anti-drug antibodies. The drug has established clinical utility across multiple hematologic and autoimmune conditions with well-characterized pharmacokinetics.

At a glance

Mechanism of action

Rituximab-pvvr is a CD20-directed monoclonal antibody that binds to the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding, it mediates B-cell lysis through two primary mechanisms: complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC). In rheumatoid arthritis, B cells play a role in pathogenesis through multiple mechanisms including production of rheumatoid factor and other autoantibodies, antigen presentation, T-cell activation, and 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: 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 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 , 6.3 ).

Common side effects

• Fatigue
• Neutrophil count decreased
• Platelet count decreased
• Lymphocyte count decreased
• Hemoglobin decreased
• Nausea
• Leukocyte count decreased
• Alanine aminotransferase increased
• Diarrhea
• Constipation
• Blood glucose increased
• Aspartate aminotransferase increased

Drug interactions

• Fludarabine
• Cyclophosphamide
• Methotrexate
• Cisplatin

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)
• Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia (PHASE1,PHASE2)
• Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial (PHASE2)
• Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (PHASE2)

Primary sources

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