What is Blitzima - Rituximab and what is it used for?
Blitzima is a medicine used in adults to treat 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 cancer);
- chronic lymphocytic leukemia (CLL, 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 the blood vessels.
Depending on the condition being treated, Blitzima can be given in combination with chemotherapy (other anticancer medicines) or medicines used for inflammatory disorders (corticosteroids). Blitzima contains the active substance rituximab.
Blitzima is a 'biosimilar medicine'. This means that it is very similar to a biological medicine (the 'reference medicine') that is already authorized in the European Union (EU). The reference medicine for Blitzima is MabThera. For more information on biosimilar medicines, please see the questions. and answers by clicking here.
How is Blitzima used?
Blitzima can only be obtained with a prescription. It is available as a concentrate to make a solution for infusion (drip) into a vein. Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an antipyretic (a fever-lowering medicine). Blitzima should be administered under the close supervision of an experienced healthcare professional and in a place where resuscitation equipment for patients is readily available.
For more information, see the package leaflet.
How does Blitzima - Rituximab work?
The active substance in Blitzima, rituximab, is a monoclonal antibody (a type of protein) designed to recognize and attach to a protein called CD20, found on the surface of B cells (types of white blood cells). When rituximab binds to CD20, it causes B cell death, benefiting lymphoma and CLL, where B cells have become cancerous. In the case of GPA and MPA, the destruction of B cells reduces the production of antibodies, which are thought to play a role in attacking blood vessels and causing inflammation.
What benefit has Blitzima - Rituximab shown during the studies?
Laboratory studies that compared Blitzima and MabThera have shown that the active ingredient of Blitzima is very similar to that of MabThera in terms of structure, purity and biological activity. Studies have also shown that administration of Blitzima produces levels of the active substance in the body similar to those of MabThera.
In addition, Blitzima was compared with MabThera given into a vein in one main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease). The study showed that Blitzima and MabThera had comparable 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 Blitzima and 73% (43 of 59 patients) with MabThera.
Additional evidence emerged from supportive studies including one involving 121 patients with advanced follicular lymphoma, in which adding Blitzima to chemotherapy drugs was at least as effective as adding Rituxan, the US version of MabThera. In this study, an improvement was observed in 96% of cases (67 of 70 patients) with Blitzima and in 90% (63 of 70 patients) with Rituxan.
Since Blitzima is a biosimilar medicine, the studies performed with MabThera regarding the efficacy and safety of rituximab do not all need to be repeated for Blitzima.
What are the risks associated with Blitzima - Rituximab?
The most common side effects of rituximab are infusion-related reactions (such as fever, chills and tremors) which occur in the majority of cancer patients and in more than 1 in 10 patients with GPA or MPA at the time of the first infusion. risk of these reactions decreases with 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 (recurrence of a "liver virus infection" previously active hepatitis B) and a rare serious brain infection known as progressive multifocal leukoencephalopathy (PML). For the full list of side effects reported with Blitzima, see the package leaflet.
Blitzima must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins, or any of the other ingredients. It should also not be used in patients with a severe infection or severely weakened immune system. Even patients with GPA or MPA should not take Blitzima if they have severe heart problems.
Why has Blitzima - Rituximab been approved?
The European Medicines Agency has decided that, in accordance with EU requirements for biosimilar medicines, Blitzima has very similar structure, purity and biological activity to MabThera and is distributed in the body in the same way. In addition, a study has put comparing Blitzima with MabThera in patients with rheumatoid arthritis (which may support its use in other inflammatory disorders such as GPA and MPA) has shown that both medicines are equally effective and a supportive study in follicular lymphoma has proven efficacy in cancer. Consequently, all of these data were considered sufficient to conclude that Blitzima will behave in the same way as MabThera in terms of efficacy in the approved indications. Therefore, the Agency considered that, as in the case of MabThera, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Blitzima.
What measures are being taken to ensure the safe and effective use of Blitzima - Rituximab?
The company that markets Blitzima will provide doctors and patients using the medicine for non-cancer conditions with educational material including information on the need to administer the medicine where resuscitation equipment is available and on the risk of infection, including progressive multifocal leukoencephalopathy. Patients should also be given an alert card to carry with them at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection.
Doctors prescribing Blitzima for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
The recommendations and precautions to be observed by healthcare professionals and patients for Blitzima to be used safely and effectively have also been reported in the summary of product characteristics and package leaflet.
More information about Blitzima - Rituximab
For the complete version of the EPAR and the summary of Blitzima's risk management plan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Blitzima therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Blitzima - Rituximab published on this page may be out of date or incomplete.For a correct use of this information, see the Disclaimer and useful information page.
