Rixathon

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rituximab

Authorised
This medicine is authorised for use in the European Union.

Overview

Rixathon is a medicine used to treat the following blood cancers and inflammatory conditions:

  • follicular lymphoma and diffuse large B cell non-Hodgkin’s lymphoma (two types of non-Hodgkin’s lymphoma, a blood cancer);
  • chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells);
  • severe rheumatoid arthritis (an inflammatory condition of the joints);
  • granulomatosis with polyangiitis (GPA or Wegener’s granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels;
  • pemphigus vulgaris, a serious condition involving widespread blistering of the skin and lining of the mouth, nose, throat and genitals.

Depending on the condition it is used to treat, Rixathon may be given on its own, or with chemotherapy (cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).

Rixathon contains the active substance rituximab.

Rixathon is a ‘biosimilar medicine’. This means that Rixathon is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Rixathon is MabThera. For more information on biosimilar medicines, see here.

This EPAR was last updated on 10/09/2021

Authorisation details

Product details
Name
Rixathon
Agency product number
EMEA/H/C/003903
Active substance
rituximab
International non-proprietary name (INN) or common name
rituximab
Therapeutic area (MeSH)
  • Lymphoma, Non-Hodgkin
  • Arthritis, Rheumatoid
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Wegener Granulomatosis
  • Microscopic Polyangiitis
  • Pemphigus
Anatomical therapeutic chemical (ATC) code
L01XC02
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Sandoz GmbH
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
15/06/2017
Contact address
Biochemiestrasse 10
6250 Kundl
Austria

Product information

20/08/2021 Rixathon - EMEA/H/C/003903 - PSUSA/00002652/202011

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Rixathon is indicated in adults for the following indications:

Non-Hodgkin’s lymphoma (NHL)
Rixathon is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy.

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

Rixathon 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.

Rixathon 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.

Rixathon 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)
Rixathon 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
Rixathon 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
Rixathon, 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).

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

Assessment history

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