What is Tuxella and what is Rituximab used for?
Tuxella 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 lymphocytic leukemia (LLC, another blood cancer that affects white blood cells);
- granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of blood vessels.
Depending on the condition to be treated, Tuxella can be given in combination with chemotherapy (other anticancer medicines) or medicines used for inflammatory disorders (corticosteroids).
Tuxella contains the active ingredient rituximab. Tuxella 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 Tuxella is MabThera. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Tuxella - Rituximab used?
Tuxella can only be obtained with a prescription. It is available as a concentrate for the preparation of a solution to be administered by infusion (drop by drop) into a vein. Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an antipyretic (a fever-lowering medicine). Tuxella should be administered under the strict control of an experienced healthcare professional and in a place where resuscitation equipment is immediately available.
For more information, see the package leaflet.
How does Tuxella - Rituximab work?
The active substance in Tuxella, rituximab, is a monoclonal antibody (a type of protein) designed to recognize a protein called CD20, present on the surface of B cells (types of white blood cells), and bind to it. When it binds to CD20, rituximab causes B cells to die, which is beneficial in the case of lymphoma and CLL, in which B cells have become cancerous. In the case of GPA and MPA, the destruction of B cells reduces the production of antibodies, which are believed to play a decisive role in attacking blood vessels and causing inflammation.
What benefit has Tuxella - Rituximab shown during the studies?
Laboratory studies that have compared Tuxella and MabThera have shown that the active ingredient of Tuxella is very similar to that of MabThera in terms of structure, purity and biological activity. Some studies have also shown that the administration of Tuxella produces levels of active ingredient in the body similar to those of MabThera.
Furthermore, Tuxella was compared with a vein-administered MabThera in one main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease). The study showed that Tuxella and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the percentage of patients with a 20% improvement in symptom score (referred to as ACR20) was 74% (114 of 155 patients) with Tuxella and 73% (43 patients out of 59) with MabThera.
Additional evidence came from supportive studies, including one involving 121 patients with advanced follicular lymphoma, in which the addition of Tuxella to chemotherapy drugs was at least as effective as the addition of Rituxan, the US version of MabThera. In this study improvements were observed in 96% of cases (67 of 70 patients) with Tuxella and in 90% (63 of 70 patients) with Rituxan.
Because Tuxella is a biosimilar medicine, studies of MabThera regarding the efficacy and safety of rituximab should not all be repeated for Tuxella.
What are the risks associated with Tuxella - Rituximab?
The most common side effects of rituximab are infusion-related reactions (such as fever, chills and tremors) that occur in most cancer patients and in more than 1 in 10 patients with GPA or MPA 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 problems. Other serious side effects include reactivation of hepatitis B (reappearance of a previously active hepatitis B virus infection) and a rare severe brain infection known as progressive multifocal leukoencephalopathy (PML). For the full list of all side effects reported with Tuxella, see the package leaflet.
Tuxella should 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 strongly weakened immune system. Not even patients with GPA or MPA should take Tuxella if they have severe heart problems.
Why has Tuxella - Rituximab been approved?
The European Medicines Agency has decided that, in accordance with EU requirements for biosimilar medicines, Tuxella has structure, purity and biological activity very similar to MabThera and is distributed in the body in the same way. Furthermore, a study that compared Tuxella with MabThera in patients with rheumatoid arthritis (which may support its use in other inflammatory disorders such as GPA and MPA) showed that the two medicines have similar efficacy and a supportive study on follicular lymphoma has shown its efficacy for cancer. Consequently, all these data were considered sufficient to conclude that Tuxella will behave in the same way as MabThera in terms of effectiveness in the approved indications. Therefore, the Agency considered that, as in the case of MabThera, the benefits outweigh the identified risks and recommended that Tuxella be given marketing authorization.
What measures are being taken to ensure the safe and effective use of Tuxella - Rituximab?
The company that markets Tuxella will provide doctors and patients who use the medicine for non-oncological conditions material including information on the need to administer the medicine where resuscitation equipment is available and the risk of infection, including progressive multifocal leukoencephalopathy. Patients must also be given an alert card, which they must always have with them, containing the instruction to immediately contact their doctor if they experience any of the listed infection symptoms.
Doctors who prescribe Tuxella for cancer will be provided with material that reminds them of the need to use the medicine only for infusion into a vein.
Recommendations and precautions to be followed by healthcare professionals and patients for Tuxella to be used safely and effectively have also been included in the summary of product characteristics and the package leaflet.
More information on Tuxella - Rituximab
The full EPAR for Tuxella can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Tuxella therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
