Rituzena (previously Tuxella)

rituximab

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This is a summary of the European public assessment report (EPAR) for Rituzena. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Rituzena.

For practical information about using Rituzena, patients should read the package leaflet or contact their doctor or pharmacist.

What is Rituzena (previously Tuxella) and what is it used for?

Rituzena (previously Tuxella) is a medicine used in adults 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);
  • granulomatosis with polyangiitis (GPA or Wegener’s granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels.

Depending on the condition it is used to treat, Rituzena (previously Tuxella) may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids). Rituzena (previously Tuxella) contains the active substance rituximab.

Rituzena (previously Tuxella) is a ‘biosimilar medicine’. This means that Rituzena (previously Tuxella) is highly similar to a biological medicine (also known as the ‘reference medicine’) that is already authorised in the European Union (EU). The reference medicine for Rituzena (previously Tuxella) is MabThera. For more information on biosimilar medicines, see 'Related content'.

How is Rituzena (previously Tuxella) used?

Rituzena (previously Tuxella) can only be obtained with a prescription. It is available as a concentrate for making a solution that must be given by infusion (drip) into a vein. Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine to reduce fever). Rituzena (previously Tuxella) should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.

For further information, see the package leaflet.

How does Rituzena (previously Tuxella) work?

The active substance in Rituzena (previously Tuxella), rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells). When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous. In GPA and MPA, destroying the B cells lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.

What benefits of Rituzena (previously Tuxella) have been shown in studies?

Laboratory studies comparing Rituzena (previously Tuxella) with MabThera have shown that the active substance in Rituzena (previously Tuxella) is highly similar to that in MabThera in terms of structure, purity and biological activity. Studies have also shown that giving Rituzena (previously Tuxella) produces similar levels of the active substance in the body to giving MabThera.

In addition, Rituzena (previously Tuxella) has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease). The study showed that Rituzena (previously Tuxella) and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Rituzena (previously Tuxella) and 73% (43 of 59 patients) with MabThera.

Further evidence came from supportive studies, including one involving 121 patients with advanced follicular lymphoma, where adding Rituzena (previously Tuxella) to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera. In this study improvement was seen in 96% of cases (67 of 70 patients) with Rituzena (previously Tuxella) and 90% (63 of 70 patients) with Rituxan.

Because Rituzena (previously Tuxella) is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Rituzena (previously Tuxella).

What are the risks associated with Rituzena (previously Tuxella)?

The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in most cancer patients and in more than 1 in 10 GPA or MPA patients at the time of the first infusion. The risk of such reactions decreases in subsequent infusions. The most common serious side effects are infusion reactions, infections and, in cancer patients, heart-related problems. Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare and severe brain infection known as progressive multifocal leukoencephalopathy (PML). For the full list of side effects reported with Rituzena (previously Tuxella), see the package leaflet.

Rituzena (previously Tuxella) must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients. It must also not be used in patients with a severe infection or a severely weakened immune system. Patients with GPA or MPA must also not receive Rituzena (previously Tuxella) if they have severe heart problems.

Why is Rituzena (previously Tuxella) approved?

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Rituzena (previously Tuxella) has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way. In addition, a study comparing Rituzena (previously Tuxella) to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer. Thus, all these data were considered sufficient to conclude that Rituzena (previously Tuxella) will behave in the same way in terms of effectiveness as MabThera in its approved indications. Therefore, the Agency’s view was that, as for MabThera, the benefit outweighs the identified risk and it recommended that Rituzena (previously Tuxella) be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Rituzena (previously Tuxella)?

The company that markets Rituzena (previously Tuxella) will provide doctors and patients using the medicine for non-cancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML. Patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection.

Doctors prescribing Rituzena (previously Tuxella) for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rituzena (previously Tuxella) have also been included in the summary of product characteristics and the package leaflet.

Other information about Rituzena (previously Tuxella)

The European Commission granted a marketing authorisation valid throughout the European Union for Rituzena (previously Tuxella) on 13 July 2017.

For more information about treatment with Rituzena (previously Tuxella), read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Rituzena : EPAR - Summary for the public BG = bălgarski 2017-08-15  
Rituzena : EPAR - Summary for the public ES = español 2017-08-15  
Rituzena : EPAR - Summary for the public CS = čeština 2017-08-15  
Rituzena : EPAR - Summary for the public DA = dansk 2017-08-15  
Rituzena : EPAR - Summary for the public DE = Deutsch 2017-08-15  
Rituzena : EPAR - Summary for the public ET = eesti keel 2017-08-15  
Rituzena : EPAR - Summary for the public EL = elliniká 2017-08-15  
Rituzena : EPAR - Summary for the public EN = English 2017-08-15  
Rituzena : EPAR - Summary for the public FR = français 2017-08-15  
Rituzena : EPAR - Summary for the public IT = italiano 2017-08-15  
Rituzena : EPAR - Summary for the public LV = latviešu valoda 2017-08-15  
Rituzena : EPAR - Summary for the public LT = lietuvių kalba 2017-08-15  
Rituzena : EPAR - Summary for the public HU = magyar 2017-08-15  
Rituzena : EPAR - Summary for the public MT = Malti 2017-08-15  
Rituzena : EPAR - Summary for the public NL = Nederlands 2017-08-15  
Rituzena : EPAR - Summary for the public PL = polski 2017-08-15  
Rituzena : EPAR - Summary for the public PT = português 2017-08-15  
Rituzena : EPAR - Summary for the public RO = română 2017-08-15  
Rituzena : EPAR - Summary for the public SK = slovenčina 2017-08-15  
Rituzena : EPAR - Summary for the public SL = slovenščina 2017-08-15  
Rituzena : EPAR - Summary for the public FI = suomi 2017-08-15  
Rituzena : EPAR - Summary for the public SV = svenska 2017-08-15  
Rituzena : EPAR - Summary for the public HR = Hrvatski 2017-08-15  

This EPAR was last updated on 15/08/2017 .

Authorisation details

Product details

Product details for Rituzena (previously Tuxella)
NameRituzena (previously Tuxella)
Agency product numberEMEA/H/C/004724
Active substance

rituximab

International non-proprietary name (INN) or common name

rituximab

Therapeutic area Wegener GranulomatosisMicroscopic PolyangiitisLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code L01XC02
Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Rituzena (previously Tuxella)
Marketing-authorisation holder

Celltrion Healthcare Hungary Kft.

Revision0
Date of issue of marketing authorisation valid throughout the European Union13/07/2017

Contact address:

Celltrion Healthcare Hungary Kft.
Bajcsy-Zsilinszky ut 12 
4. em. 410
1051 Budapest
Hungary

Product information

Product information

13/07/2017  Rituzena (previously Tuxella) -EMEA/H/C/004724 --

Name Language First published Last updated
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  
Rituzena : EPAR - Product Information HR = Hrvatski 2017-08-15  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  
Rituzena : EPAR - All Authorised presentations HR = Hrvatski 2017-08-15  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Rituzena is indicated in adults for the following indications:

  • Non-Hodgkin’s lymphoma (NHL) Rituzena is indicated for the treatment of previously untreated patients with stage III, IV follicular lymphoma in combination with chemotherapy.
  • Rituzena monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.
  • Rituzena 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) Rituzena 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 Rituzena or patients refractory to previous Rituzena plus chemotherapy. See section 5.1 for further information.
  • Granulomatosis with polyangiitis and microscopic polyangiitis Rituzena, 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).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Rituzena : EPAR - Public assessment report HR = Hrvatski 2017-08-15  
CHMP summary of positive opinion for Tuxella HR = Hrvatski 2017-05-19  

Authorised

This medicine is approved for use in the European Union

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