Riximyo

ATC：L01FA01

治疗领域：Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;Microscopic Polyangiitis;Wegener Granulomatosis

药理分类：Antineoplastic agents

修订号：18 · 最新影响 PI 的程序：VR/0000355500

适应症（原文）：Riximyo is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Riximyo is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. Riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. Riximyo monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. Riximyo is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ? 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL). Chronic lymphocytic leukaemia (CLL) Riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy. See section 5.1 for further information. Rheumatoid arthritis Riximyo 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. 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 Riximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). Riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ? 2 to < 18 years old) with severe, active GPA (Wegener’s) and MPA. Pemphigus vulgaris Riximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).