drugs

Riximyo - Rituximab

What is Riximyo and what is it used for?

Riximyo 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 forms of non-Hodgkin's lymphoma, a blood tumor);
  • 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 blood vessels.

Depending on the condition to be treated, Riximyo can be given as monotherapy or in combination with chemotherapy (other anticancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid). Riximyo contains the active ingredient rituximab.

Riximyo 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 Riximyo is MabThera. For more information on biosimilar medicines, see the questions and answers by clicking here.

How is Riximyo used - Rituximab?

Riximyo 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 medicine). The medicine should be administered under the strict supervision of an experienced healthcare professional and where resuscitation equipment for patients is readily available.

For more information, see the package leaflet.

How does Riximyo - Rituximab work?

The active substance in Riximyo, 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 (where B cells have become cancerous) and rheumatoid arthritis (where B cells contribute to joint inflammation). 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 Riximyo - Rituximab shown during the studies?

Laboratory studies that have compared Riximyo and MabThera have shown that the active ingredient of Riximyo is very similar to that of MabThera in terms of structure, purity and biological activity.

Because Riximyo is a biosimilar medicine, studies of MabThera regarding the efficacy and safety of rituximab should not all be repeated for Riximyo. Studies have been conducted to show that the administration of Riximyo produces levels of active substance in the body similar to those of MabThera.

Furthermore, Riximyo was as effective as MabThera in a main study of 629 patients with advanced untreated follicular lymphoma, in which Riximyo or MabThera were added to other chemotherapy for part of the treatment. Cancer responded to treatment in 87% of patients given Riximyo (271 of 311 patients) and in a similar number of those who received MabThera (274 of 313 patients). A supportive study in patients with rheumatoid arthritis also indicated similar efficacy between MabThera and Riximyo.

What are the risks associated with Riximyo - 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 about a quarter of patients with rheumatoid arthritis 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 Riximyo, see the package leaflet.

Riximyo 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 rheumatoid arthritis, GPA or MPA should take Riximyo if they have severe heart problems.

Why has Riximyo been approved - Rituximab?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Riximyo has structure, purity and biological activity very similar to MabThera and is distributed in the body in the same way . Furthermore, a study comparing Riximyo and MabThera in patients with follicular lymphoma has shown that the two medicines have similar efficacy. Consequently, all these data were considered sufficient to conclude that Riximyo will behave in the same way as MabThera in terms of efficacy in the approved indications. Therefore, the CHMP considered that, as in the case of MabThera, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Riximyo.

What measures are being taken to ensure the safe and effective use of Riximyo - Rituximab?

The company that markets Riximyo will provide doctors and patients who use the non-cancer medicine with information material including instructions 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 Riximyo 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 Riximyo to be used safely and effectively have also been included in the summary of product characteristics and the package leaflet.

More information on Riximyo - Rituximab

For the full version of the EPAR and the summary of the Riximyo risk management plan, see the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Riximyo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.