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Active Substance: rituximab
Common Name: rituximab
ATC Code: L01XC02
Marketing Authorisation Holder: Roche Registration Ltd
Active Substance: rituximab
Status: Authorised
Authorisation Date: 1998-06-02
Therapeutic Area: Arthritis, Rheumatoid Lymphoma, Non-Hodgkin Leukemia, Lymphocytic, Chronic, B-Cell
Pharmacotherapeutic Group: Antineoplastic agents

Therapeutic indication

MabThera is indicated in adults for the following indications:

Non-Hodgkin's lymphoma

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

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

MabThera 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 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

MabThera 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 MabThera or patients refractory to previous MabThera plus chemotherapy.

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 antirheumatic drugs (DMARDs) 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.

What is MabThera and what is it used for?

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

Depending on the condition it is used to treat, MabThera may be given on its own, or with chemotherapy, methotrexate or a corticosteroid. MabThera contains the active substance rituximab.

How is MabThera used?

MabThera is given as an infusion (drip) into a vein. Patients with blood cancers can switch to an injection given under the skin after they have received one full dose of the infusion.

Before each infusion or injection, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine for fever). In addition, the medicine should be given under the close supervision of an experienced healthcare professional and in an environment where facilities for resuscitating patients are immediately available.

MabThera is available as a concentrate that is made up into the solution for infusion and as a ready-made solution for the injection under the skin. It can only be obtained with a prescription.

How does MabThera work?

The active substance in MabThera, rituximab, is a monoclonal antibody designed to recognise and attach to a protein called CD20 present on the surface of B‑lymphocytes. When rituximab attaches to CD20, it causes the death of B‑lymphocytes, which helps in lymphoma and CLL (where B-lymphocytes have become cancerous) and in rheumatoid arthritis (where B‑lymphocytes are involved in joint inflammation). In GPA and MPA, destroying the B-lymphocytes lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.

What benefits of MabThera have been shown in studies?

Studies show:

MabThera to be effective in treating all the conditions for which it is approved. Some results from the main studies on the benefits of MabThera are described below:

What is the risk associated with MabThera?

The most common side effects with Mabthera intravenous infusions are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heart-related problems. Similar side effects are seen when Mabthera is injected under the skin, with the exception of reactions around the injections site (pain, swelling and rash), which occur more frequently with the skin injections. For the full list of side effects reported with MabThera, see the package leaflet.

MabThera must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients or in patients with a severe infection or a severely weakened immune system. The formulation injected under the skin must also not be used in patients who are allergic to a substance called hyaluronidase.

Patients with rheumatoid arthritis, GPA or MPA must not receive MabThera if they have severe heart problems.

Why has MabThera been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that MabThera’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of MabThera?

The company marketing MabThera will provide doctors and patients using the medicine for rheumatoid arthritis with educational material on the risk of infection including of a rare severe infection known as progressive multifocal leukoencephalopathy (PML). These 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 experience symptoms of infection.

All doctors administering MabThera under the skin will also receive educational material to minimise the risk of improper use or errors.

In addition, the company that markets MabThera will also submit reports from studies on the long-term safety of MabThera.

Finally, recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of MabThera have been included in the summary of product characteristics and the package leaflet.

Other information about MabThera

The European Commission granted a marketing authorisation valid throughout the European Union for MabThera on 2 June 1998.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.