Rituximab is the first therapeutic monoclonal antibody to target cells that have the CD20 marker on their surface.
Rituximab is sold under the brand name Mabthera and Rituxan among others. MabThera is market as Rituxan in USA, Japan and Canada.
MabThera/Rituxan (Rituximab) is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
MabThera/Rituxan (Rituximab) is indicated for:
Non-Hodgkin’s lymphoma (NHL)
MabThera/Rituxan (Rituximab) is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
MabThera/Rituxan (Rituximab) maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
MabThera/Rituxan (Rituximab) monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
MabThera/Rituxan (Rituximab) is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Chronic lymphocytic leukaemia (CLL)
MabThera/Rituxan (Rituximab) in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera/Rituxan (Rituximab) or patients refractory to previous MabThera plus chemotherapy.
See section 5.1 for further information.
Rheumatoid arthritis
MabThera/Rituxan (Rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
MabThera/Rituxan (Rituximab) has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Granulomatosis with polyangiitis and microscopic polyangiitis
MabThera/Rituxan (Rituximab), in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
