What is Truxima and what is Rituximab used for?
Truxima is a medicine used in adults for the treatment of blood cancers and inflammatory conditions described below:
- follicular lymphoma and diffuse large B-cell non-Hodgkin's lymphoma (two forms of non-Hodgkin's lymphoma, a blood tumor);
- chronic lymphatic leukemia (LLC, another blood cancer that affects white blood cells);
- rheumatoid arthritis (an inflammatory condition of the joints) of severe grade;
- granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis (MPA), or inflammatory conditions of blood vessels.
Depending on the condition to be treated, Truxima can be given as monotherapy or in combination with chemotherapy (other anticancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid). Truxima contains the active ingredient rituximab.
Truxima is a "biosimilar medicine". This means that it is very similar to a biological medicine (the "reference medicine") that has already been authorized in the European Union (EU). The reference medicine for Truxima is MabThera. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Truxima - Rituximab used?
Truxima can only be obtained with a prescription. It is available as a concentrate for the preparation of a solution for infusion (drip) into a vein. Before each infusion the patient must receive an antihistamine (to prevent allergic reactions) and an antipyretic (a fever medicine). In addition, the medicine must be administered under the strict control of an experienced healthcare professional and in an environment with immediate availability of resuscitation equipment.
For more information, see the package leaflet.
How does Truxima - Rituximab work?
The active substance in Truxima, rituximab, is a monoclonal antibody (a type of protein) designed to recognize a protein called CD20, present on the surface of B lymphocytes (a type of white blood cell), and bind to it. When rituximab binds to CD20, it causes the death of B lymphocytes, benefiting lymphoma and CLL (where B lymphocytes have become cancerous) and rheumatoid arthritis (where B lymphocytes contribute to joint inflammation) . In the treatment of GPA and MPA, the destruction of B lymphocytes reduces the production of antibodies, which are believed to contribute significantly to attacking blood vessels and causing inflammation.
What benefit has Truxima - Rituximab shown during the studies?
Large-scale laboratory studies that compared Truxima and MabThera showed that the rituximab contained in Truxima is very similar to the rituximab contained in MabThera in terms of chemical structure, purity and biological activity.
Because Truxima is a biosimilar medicine, studies on MabThera regarding efficacy and safety should not be repeated for Truxima. Truxima was compared with intravenously administered MabThera in a study involving 372 patients with active rheumatoid arthritis. The study showed that Truxima and MabThera produced similar levels of rituximab in the blood. Furthermore, the two medicines had similar effects on arthritis symptoms: after 24 weeks the percentage of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Truxima and 73 % (43 of 59 patients) with MabThera. Supportive studies in patients with rheumatoid arthritis and in patients with advanced follicular lymphoma also indicated that the drugs produced similar responses.
What are the risks associated with Truxima - Rituximab?
The most common side effects of rituximab are infusion-related reactions (such as fever, chills and tremors) that occur in most patients after the first infusion. The risk of such reactions decreases in subsequent infusions. The most common serious side effects are infusion reactions, infections (which can affect more than half of all patients) and heart problems. Other serious side effects include reactivation of hepatitis B (reappearance of a previous active liver infection with hepatitis B virus) and a severe rare infection known as progressive multifocal leukoencephalopathy. For the full list of all side effects reported with Truxima, see the package leaflet.
Truxima should not be used in people who are hypersensitive (allergic) to rituximab, protein in mice or any of the other ingredients. It must not be used in patients with a serious ongoing infection or a strongly weakened immune system. Patients with rheumatoid arthritis, GPA or MPA should not take Truxima if they have severe heart problems.
Why has Truxima - Rituximab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has decided that, in accordance with EU requirements for biosimilar medicines, Truxima has structure, purity and biological activity very similar to MabThera and is distributed in the body in the same way . Furthermore, a study comparing Truxima and MabThera in adult patients with rheumatoid arthritis has shown that the two medicines have similar efficacy. Consequently, all these data were considered sufficient to conclude that Truxima will behave in the same way as MabThera in terms of effectiveness in the approved indications. Therefore, the CHMP considered that, as in the case of MabThera, the benefits outweigh the identified risks and recommended that Truxima be given marketing authorization.
What measures are being taken to ensure the safe and effective use of Truxima - Rituximab?
The company that markets Truxima will provide doctors and patients who use the medicine for rheumatoid arthritis with information material on the need to administer the medicine where resuscitation equipment and the risk of infection are available, including progressive multifocal leukoencephalopathy. Patients must also be given an alert card, which they must always have with them, with instructions on how to immediately contact their doctor if they show the listed infection symptoms.
Doctors who prescribe Truxima for cancer will be provided with information material that reminds them of the need to use the medicine only as an intravenous infusion.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truxima have also been included in the summary of product characteristics and the package leaflet.
More information on Truxima - Rituximab
For the full EPAR of Truxima, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Truxima, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist
