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Drug information

MabThera

POM
Read time: 99 mins
Last updated: 06 May 2020
Published: 01 Apr 2021

4.1 Therapeutic indications

MabThera is indicated in adults for the following indications:

Non-Hodgkin's lymphoma (NHL)

MabThera is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy.

MabThera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.

MabThera 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.

MabThera 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.

MabThera 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)

MabThera 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 or patients refractory to previous MabThera plus chemotherapy.

See section 5.1 for further information.

Rheumatoid arthritis

MabThera 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 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, 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).

MabThera, 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

MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

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Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).