This is a summary of the European public assessment report (EPAR) for Ritemvia. 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 Ritemvia.
For practical information about using Ritemvia, patients should read the package leaflet or contact their doctor or pharmacist.
What is Ritemvia and what is it used for?
Ritemvia is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
•follicular lymphoma and diffuse large B cell
•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, Ritemvia may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids). Ritemvia contains the active substance rituximab.
Ritemvia is a ‘biosimilar medicine’. This means that Ritemvia 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 Ritemvia is MabThera. For more information on biosimilar medicines, see the
How is Ritemvia used?
Ritemvia 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
For further information, see the package leaflet.
How does Ritemvia work?
The active substance in Ritemvia, 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 Ritemvia have been shown in studies?
- Rituzena (tuxella) - Celltrion Healthcare Hungary Kft.
- Truxima - Celltrion Healthcare Hungary Kft.
- Blitzima - Celltrion Healthcare Hungary Kft.
- Remsima - Celltrion Healthcare Hungary Kft.
Prescription drugs listed. Manufacturer: "Celltrion Healthcare Hungary Kft."
Laboratory studies comparing Ritemvia with MabThera have shown that the active substance in Ritemvia is highly similar to that in MabThera in terms of structure, purity and biological activity. Studies have also shown that giving Ritemvia produces similar levels of the active substance in the body to giving MabThera.
In addition, Ritemvia 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 Ritemvia 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 Ritemvia 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 Ritemvia 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 Ritemvia and 90% (63 of 70 patients) with Rituxan.
Because Ritemvia is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Ritemvia.
What are the risks associated with Ritemvia?
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,
Ritemvia 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 Ritemvia if they have severe heart problems.
Why is Ritemvia approved?
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ritemvia 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 Ritemvia 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 Ritemvia 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 Ritemvia be given marketing authorisation.
What measures are being taken to ensure the safe and effective use of Ritemvia?
The company that markets Ritemvia 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 Ritemvia 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 Ritemvia have also been included in the summary of product characteristics and the package leaflet.
Other information about Ritemvia
The European Commission granted a marketing authorisation valid throughout the European Union for Ritemvia on 13 July 2017.
The full EPAR for Ritemvia can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Ritemvia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in